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Trial record 1 of 1 for:    NCT02723175
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The Effects of CBT and tDCS on Fibromyalgia Patients

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ClinicalTrials.gov Identifier: NCT02723175
Recruitment Status : Completed
First Posted : March 30, 2016
Results First Posted : November 28, 2018
Last Update Posted : November 28, 2018
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by (Responsible Party):
Medical University of South Carolina

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Fibromyalgia
Chronic Pain
Intervention Device: Transcranial Direct Current Stimulation
Enrollment 15
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Sham tDCS Stimulation Anodal tDCS Stimulation of DLPFC
Hide Arm/Group Description

30 minutes of the sham transcranial Direct Current Stimulation

Transcranial Direct Current Stimulation: Transcranial Direct Current Stimulation is a minimally invasive technique that uses a small amount of electricity (2mA) to temporarily stimulate specific brain areas in awake people.

30 minutes of the active transcranial Direct Current Stimulation (tDCS)

Transcranial Direct Current Stimulation: Transcranial Direct Current Stimulation is a minimally invasive technique that uses a small amount of electricity (2mA) to temporarily stimulate specific brain areas in awake people.

Period Title: Overall Study
Started 8 7
Completed 4 4
Not Completed 4 3
Reason Not Completed
Lost to 1 Month Follow Up             3             2
Lost to 3 Month Follow Up             1             1
Arm/Group Title Sham tDCS Stimulation Anodal tDCS Stimulation of DLPFC Total
Hide Arm/Group Description

30 minutes of the sham transcranial Direct Current Stimulation

Transcranial Direct Current Stimulation: Transcranial Direct Current Stimulation is a minimally invasive technique that uses a small amount of electricity (2mA) to temporarily stimulate specific brain areas in awake people.

30 minutes of the active transcranial Direct Current Stimulation (tDCS)

Transcranial Direct Current Stimulation: Transcranial Direct Current Stimulation is a minimally invasive technique that uses a small amount of electricity (2mA) to temporarily stimulate specific brain areas in awake people.

Total of all reporting groups
Overall Number of Baseline Participants 8 7 15
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 7 participants 15 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
8
 100.0%
7
 100.0%
15
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 8 participants 7 participants 15 participants
50.75  (10.25) 48  (14.69) 49.47  (12.12)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 7 participants 15 participants
Female 7 6 13
Male 1 1 2
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 7 participants 15 participants
American Indian or Alaska Native 0 0 0
Asian 0 0 0
Native Hawaiian or Other Pacific Islander 0 0 0
Black or African American 1 0 1
White 7 7 14
More than one race 0 0 0
Unknown or Not Reported 0 0 0
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 8 participants 7 participants 15 participants
8 7 15
1.Primary Outcome
Title Baseline Quantitative Sensory Testing (QST)
Hide Description Before treatment, Quantitative Sensory Testing (QST) will be completed for all participants. The QST involves a comprehensive laboratory pain assessment including heat stimuli using a Pathway Thermo-sensory Analyzer System which is specifically designed for assessing laboratory pain testing. The QST collects the temperature in celsius of when the participant first begins to feel the stimuli (Sensory), starts to feel pain (average pain threshold), and when the participant can no longer tolerate the stimuli (Tolerance). The temperature ranges from 37 degrees celsius to 50 degrees celsius. The minimum temperature on the scale is 37 degrees celsius and the maximum temperature on the scale is 50 degrees celsius. Average pain threshold: A lower temperature represents a lower pain threshold and a higher temperature represents a higher pain threshold. Tolerance: A lower temperature represents a lower pain tolerance and a higher temperature represents a higher pain tolerance.
Time Frame Before Treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sham tDCS Stimulation Anodal tDCS Stimulation of DLPFC
Hide Arm/Group Description:

30 minutes of the sham transcranial Direct Current Stimulation

Transcranial Direct Current Stimulation: Transcranial Direct Current Stimulation is a minimally invasive technique that uses a small amount of electricity (2mA) to temporarily stimulate specific brain areas in awake people.

30 minutes of the active transcranial Direct Current Stimulation (tDCS)

Transcranial Direct Current Stimulation: Transcranial Direct Current Stimulation is a minimally invasive technique that uses a small amount of electricity (2mA) to temporarily stimulate specific brain areas in awake people.

Overall Number of Participants Analyzed 8 7
Mean (Standard Deviation)
Unit of Measure: Degrees Celsius
Sensory 39.7063  (2.37354) 39.8286  (1.85452)
Average Pain Threshold 43.9563  (3.19553) 45.2036  (3.08134)
Tolerance 46.1531  (3.53357) 47.2036  (2.24743)
2.Primary Outcome
Title Post Baseline Quantitative Sensory Testing (QST)
Hide Description After treatment, Quantitative Sensory Testing (QST) will be completed for all participants. The QST involves a comprehensive laboratory pain assessment including heat stimuli using a Pathway Thermo-sensory Analyzer System which is specifically designed for assessing laboratory pain testing. The QST collects the temperature in celsius of when the participant first begins to feel the stimuli (Sensory), starts to feel pain (average pain threshold), and when the participant can no longer tolerate the stimuli (Tolerance). The temperature ranges from 37 degrees celsius to 50 degrees celsius. The minimum temperature on the scale is 37 degrees celsius and the maximum temperature on the scale is 50 degrees celsius. Average pain threshold: A lower temperature represents a lower pain threshold and a higher temperature represents a higher pain threshold. Tolerance: A lower temperature represents a lower pain tolerance and a higher temperature represents a higher pain tolerance.
Time Frame One week Post Treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sham tDCS Stimulation Anodal tDCS Stimulation of DLPFC
Hide Arm/Group Description:

30 minutes of the sham transcranial Direct Current Stimulation

Transcranial Direct Current Stimulation: Transcranial Direct Current Stimulation is a minimally invasive technique that uses a small amount of electricity (2mA) to temporarily stimulate specific brain areas in awake people.

30 minutes of the active transcranial Direct Current Stimulation (tDCS)

Transcranial Direct Current Stimulation: Transcranial Direct Current Stimulation is a minimally invasive technique that uses a small amount of electricity (2mA) to temporarily stimulate specific brain areas in awake people.

Overall Number of Participants Analyzed 5 6
Mean (Standard Deviation)
Unit of Measure: Degrees Celsius
Sensory 39.2350  (3.53613) 38.9083  (2.63726)
Average Pain Threshold 42.3050  (4.94057) 44.1042  (4.10668)
Tolerance 44.1050  (5.50248) 46.0417  (4.35634)
3.Secondary Outcome
Title The Beck Depression Inventory (BDI) at Baseline
Hide Description The Beck Depression Inventory (BDI) will be used for screening purposes to characterize depression in each participant at baseline. The BDI is a 21 item participant rated inventory that evaluates depression symptoms, cognition, and physical symptoms of fatigue, weight loss, lack of interest in sex. The BDI scale also assesses suicidal ideation, those patients exhibiting suicidal ideations will be referenced to a therapist in order to further manage their depressive symptoms. The Total score range is 0 to 63; higher score indicates more depression. Individual items are scored on a 4 point scale (0 to 3), with 0=none/absent and 3=most severe.
Time Frame Before Treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sham tDCS Stimulation Anodal tDCS Stimulation of DLPFC
Hide Arm/Group Description:

30 minutes of the sham transcranial Direct Current Stimulation

Transcranial Direct Current Stimulation: Transcranial Direct Current Stimulation is a minimally invasive technique that uses a small amount of electricity (2mA) to temporarily stimulate specific brain areas in awake people.

30 minutes of the active transcranial Direct Current Stimulation (tDCS)

Transcranial Direct Current Stimulation: Transcranial Direct Current Stimulation is a minimally invasive technique that uses a small amount of electricity (2mA) to temporarily stimulate specific brain areas in awake people.

Overall Number of Participants Analyzed 8 7
Mean (Standard Deviation)
Unit of Measure: units on a scale
21.38  (14.55) 23.86  (11.82)
4.Secondary Outcome
Title The Beck Anxiety Inventory (BAI) at Baseline
Hide Description The Beck Anxiety Inventory (BAI) is a well-researched, brief self-report anxiety-screening instrument that assesses different aspects of anxiety experience (e.g., physiological, cognitive, behavioral). It was designed to measure participant's level of anxiety. The scale is unidimensional and the total score rages from 0 to 63. Low scores are associated with low levels of anxiety, while high scores are associated with high levels of anxiety.
Time Frame Before Treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sham tDCS Stimulation Anodal tDCS Stimulation of DLPFC
Hide Arm/Group Description:

30 minutes of the sham transcranial Direct Current Stimulation

Transcranial Direct Current Stimulation: Transcranial Direct Current Stimulation is a minimally invasive technique that uses a small amount of electricity (2mA) to temporarily stimulate specific brain areas in awake people.

30 minutes of the active transcranial Direct Current Stimulation (tDCS)

Transcranial Direct Current Stimulation: Transcranial Direct Current Stimulation is a minimally invasive technique that uses a small amount of electricity (2mA) to temporarily stimulate specific brain areas in awake people.

Overall Number of Participants Analyzed 8 7
Mean (Standard Deviation)
Unit of Measure: units on a scale
12.75  (12.67) 23.00  (11.33)
5.Secondary Outcome
Title Brief Pain Inventory-Average Pain at Baseline
Hide Description To assess each participant's average pain at baseline, the Brief Pain Inventory (BPI)-short form will be administered. The BPI rapidly assesses the severity of pain and its impact on functioning and has been widely used in both research and clinical settings. Participants rate their average pain in the past 24 hours using a 0-10 numerical rating scale, where 0=no pain and 10=extreme pain.
Time Frame Before Treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sham tDCS Stimulation Anodal tDCS Stimulation of DLPFC
Hide Arm/Group Description:

30 minutes of the sham transcranial Direct Current Stimulation

Transcranial Direct Current Stimulation: Transcranial Direct Current Stimulation is a minimally invasive technique that uses a small amount of electricity (2mA) to temporarily stimulate specific brain areas in awake people.

30 minutes of the active transcranial Direct Current Stimulation (tDCS)

Transcranial Direct Current Stimulation: Transcranial Direct Current Stimulation is a minimally invasive technique that uses a small amount of electricity (2mA) to temporarily stimulate specific brain areas in awake people.

Overall Number of Participants Analyzed 8 7
Mean (Standard Deviation)
Unit of Measure: units on a scale
5.69  (2.39) 7.06  (2.27)
6.Secondary Outcome
Title Percent Change in Average Daily Pain at Treatment Visit 3
Hide Description Participants were asked to rate their pain on average every day from the start of Treatment 1 until Treatment 3. Average pain ratings were on 0-10 scale. 0=No Pain at all and 10=Extreme Pain. Daily ratings were averaged at treatment 1 and treatment 3. The change in average daily pain ratings from treatment 1 to treatment 3 was calculated below. Time points at week 1 and week 3 were included to calculate percent change.
Time Frame Treatment Session 3 (week 3)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sham tDCS Stimulation Anodal tDCS Stimulation of DLPFC
Hide Arm/Group Description:

30 minutes of the sham transcranial Direct Current Stimulation

Transcranial Direct Current Stimulation: Transcranial Direct Current Stimulation is a minimally invasive technique that uses a small amount of electricity (2mA) to temporarily stimulate specific brain areas in awake people.

30 minutes of the active transcranial Direct Current Stimulation (tDCS)

Transcranial Direct Current Stimulation: Transcranial Direct Current Stimulation is a minimally invasive technique that uses a small amount of electricity (2mA) to temporarily stimulate specific brain areas in awake people.

Overall Number of Participants Analyzed 7 6
Mean (Standard Deviation)
Unit of Measure: percent change
-13.29  (24.66) -3.73  (12.64)
7.Secondary Outcome
Title Affective Subscale of McGill Pain Questionnaire at Baseline
Hide Description Participants completed the McGill Pain Questionnaire-short form (MPQ) at Baseline. The possible total range of scores (Sensory and Affective subscales together) is 0 to 45. The MPQ has two pain dimensions: 1.Sensory subscale awith 11 words, and 2.Affective subscale with 4 words from the original MPQ. The range of scores for the sensory dimension of pain is 0-33. The data below report the mean score for the affective subscale for both groups. The range of scores for the affective subscale being 0-12 with Higher scores indicating worse pain.
Time Frame Before Treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sham tDCS Stimulation Anodal tDCS Stimulation of DLPFC
Hide Arm/Group Description:

30 minutes of the sham transcranial Direct Current Stimulation

Transcranial Direct Current Stimulation: Transcranial Direct Current Stimulation is a minimally invasive technique that uses a small amount of electricity (2mA) to temporarily stimulate specific brain areas in awake people.

30 minutes of the active transcranial Direct Current Stimulation (tDCS)

Transcranial Direct Current Stimulation: Transcranial Direct Current Stimulation is a minimally invasive technique that uses a small amount of electricity (2mA) to temporarily stimulate specific brain areas in awake people.

Overall Number of Participants Analyzed 8 7
Mean (Standard Deviation)
Unit of Measure: units on a scale
5.625  (3.24) 6.714  (2.91)
8.Secondary Outcome
Title The Short-Form 12 Healthy Survey at Baseline
Hide Description To assess each participant's mental and physical functioning at Baseline, The Short-Form 12 Healthy Survey (SF-12) will be administered. The SF-12 is a multipurpose short form survey with 12 questions, all selected from the SF-36 Health Survey (Ware, Kosinski, and Keller, 1996). The questions were combined, scored, and weighted to create two scales that provide glimpses into mental and physical functioning and overall health-related-quality of life. Total score range for the summary scores = 0-100, where higher score represents higher level of functioning.
Time Frame Before Treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sham tDCS Stimulation Anodal tDCS Stimulation of DLPFC
Hide Arm/Group Description:

30 minutes of the sham transcranial Direct Current Stimulation

Transcranial Direct Current Stimulation: Transcranial Direct Current Stimulation is a minimally invasive technique that uses a small amount of electricity (2mA) to temporarily stimulate specific brain areas in awake people.

30 minutes of the active transcranial Direct Current Stimulation (tDCS)

Transcranial Direct Current Stimulation: Transcranial Direct Current Stimulation is a minimally invasive technique that uses a small amount of electricity (2mA) to temporarily stimulate specific brain areas in awake people.

Overall Number of Participants Analyzed 8 7
Mean (Standard Deviation)
Unit of Measure: units on a scale
30.13  (1.55) 31.14  (2.73)
9.Secondary Outcome
Title The Fibromyalgia (FM) Impact Questionnaire at Baseline
Hide Description To assess the impact of fibromyalgia on each participant's function at baseline, The Fibromyalgia (FM) Impact Questionnaire will be administered. The FM assesses the following symptoms; physical Impairment, well-being, pain, fatigue, rested, stiffness, anxiety, and depression within the past 24 hours. Each symptom scale ranges from 0 to 10. For example, 0=no pain and 10=extreme pain, 0=not fatigued and 10=extremely fatigued. The final score is the total score which ranges from 0 to 80. Higher scores indicate greater impact of fibromyalgia on functioning.
Time Frame Before Treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sham tDCS Stimulation Anodal tDCS Stimulation of DLPFC
Hide Arm/Group Description:

30 minutes of the sham transcranial Direct Current Stimulation

Transcranial Direct Current Stimulation: Transcranial Direct Current Stimulation is a minimally invasive technique that uses a small amount of electricity (2mA) to temporarily stimulate specific brain areas in awake people.

30 minutes of the active transcranial Direct Current Stimulation (tDCS)

Transcranial Direct Current Stimulation: Transcranial Direct Current Stimulation is a minimally invasive technique that uses a small amount of electricity (2mA) to temporarily stimulate specific brain areas in awake people.

Overall Number of Participants Analyzed 8 7
Mean (Standard Deviation)
Unit of Measure: units on a scale
3.46  (1.61) 3.96  (0.79)
10.Secondary Outcome
Title The Beck Depression Inventory (BDI) at 1 Month Follow up
Hide Description The Beck Depression Inventory (BDI) will be used for screening purposes to characterize depression in each participant at the one month follow up visit. The BDI is a 21 item participant rated inventory that evaluates depression symptoms, cognition, and physical symptoms of fatigue, weight loss, lack of interest in sex. The BDI scale also assesses suicidal ideation, those patients exhibiting suicidal ideations will be referenced to a therapist in order to further manage their depressive symptoms. The Total score range is 0 to 63; higher score indicates more depression. Individual items are scored on a 4 point scale (0 to 3), with 0=none/absent and 3=most severe.
Time Frame 1 month follow up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sham tDCS Stimulation Anodal tDCS Stimulation of DLPFC
Hide Arm/Group Description:

30 minutes of the sham transcranial Direct Current Stimulation

Transcranial Direct Current Stimulation: Transcranial Direct Current Stimulation is a minimally invasive technique that uses a small amount of electricity (2mA) to temporarily stimulate specific brain areas in awake people.

30 minutes of the active transcranial Direct Current Stimulation (tDCS)

Transcranial Direct Current Stimulation: Transcranial Direct Current Stimulation is a minimally invasive technique that uses a small amount of electricity (2mA) to temporarily stimulate specific brain areas in awake people.

Overall Number of Participants Analyzed 5 5
Mean (Standard Deviation)
Unit of Measure: units on a scale
15.40  (18.96) 17.40  (13.69)
11.Secondary Outcome
Title The Beck Anxiety Inventory (BAI) at 3 Month Follow Up
Hide Description The Beck Anxiety Inventory (BAI) is a well-researched, brief self-report anxiety-screening instrument that assesses different aspects of anxiety experience (e.g., physiological, cognitive, behavioral). It was designed to measure participant's level of anxiety. The scale is unidimensional and the total score rages from 0 to 63. Low scores are associated with low levels of anxiety, while high scores are associated with high levels of anxiety.
Time Frame 3 Month Follow Up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sham tDCS Stimulation Anodal tDCS Stimulation of DLPFC
Hide Arm/Group Description:

30 minutes of the sham transcranial Direct Current Stimulation

Transcranial Direct Current Stimulation: Transcranial Direct Current Stimulation is a minimally invasive technique that uses a small amount of electricity (2mA) to temporarily stimulate specific brain areas in awake people.

30 minutes of the active transcranial Direct Current Stimulation (tDCS)

Transcranial Direct Current Stimulation: Transcranial Direct Current Stimulation is a minimally invasive technique that uses a small amount of electricity (2mA) to temporarily stimulate specific brain areas in awake people.

Overall Number of Participants Analyzed 4 4
Mean (Standard Deviation)
Unit of Measure: units on a scale
14.75  (23.09) 16.75  (14.41)
12.Secondary Outcome
Title Brief Pain Inventory-Average Pain at 1 Month Follow Up
Hide Description At the one month follow up visit, The Brief Pain Inventory (BPI)-short form will be administered to assess each participant's pain on average in the past 30 days. The BPI rapidly assesses the severity of pain and its impact on functioning and has been widely used in both research and clinical settings. Participants rate their pain on average in the past 30 days using a 0-10 numerical rating scale, where 0=no pain and 10=extreme pain.
Time Frame 1 Month Follow Up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sham tDCS Stimulation Anodal tDCS Stimulation of DLPFC
Hide Arm/Group Description:

30 minutes of the sham transcranial Direct Current Stimulation

Transcranial Direct Current Stimulation: Transcranial Direct Current Stimulation is a minimally invasive technique that uses a small amount of electricity (2mA) to temporarily stimulate specific brain areas in awake people.

30 minutes of the active transcranial Direct Current Stimulation (tDCS)

Transcranial Direct Current Stimulation: Transcranial Direct Current Stimulation is a minimally invasive technique that uses a small amount of electricity (2mA) to temporarily stimulate specific brain areas in awake people.

Overall Number of Participants Analyzed 5 5
Mean (Standard Deviation)
Unit of Measure: units on a scale
3.78  (3.21) 3.53  (1.91)
13.Secondary Outcome
Title Percent Change in Average Daily Pain at Treatment Visit Six
Hide Description Participants were asked to rate their pain on average every day from the start of Treatment 3 until Treatment 6. Average pain ratings were on 0-10 scale. 0=No Pain at all and 10=Extreme Pain. Daily ratings were averaged at treatment 3 and treatment 6. The change in average daily pain ratings from treatment 3 to treatment 6 was calculated below. Time points at week 3, and week 6 were included to calculate percent change.
Time Frame Treatment Session 6 (week 6)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sham tDCS Stimulation Anodal tDCS Stimulation of DLPFC
Hide Arm/Group Description:

30 minutes of the sham transcranial Direct Current Stimulation

Transcranial Direct Current Stimulation: Transcranial Direct Current Stimulation is a minimally invasive technique that uses a small amount of electricity (2mA) to temporarily stimulate specific brain areas in awake people.

30 minutes of the active transcranial Direct Current Stimulation (tDCS)

Transcranial Direct Current Stimulation: Transcranial Direct Current Stimulation is a minimally invasive technique that uses a small amount of electricity (2mA) to temporarily stimulate specific brain areas in awake people.

Overall Number of Participants Analyzed 5 6
Mean (Standard Deviation)
Unit of Measure: percent change
-24.17  (31.51) -5.32  (16.28)
14.Secondary Outcome
Title Percent Change in Average Daily Pain at 1 Month Follow Up
Hide Description Participants were asked to rate their pain on average every day 30 days post treatment 6 (1 month follow up). Average pain ratings were on 0-10 scale. 0=No Pain at all and 10=Extreme Pain. The 30 Daily ratings (Post Treatment 6) were averaged and The change in average daily pain ratings from treatment 6 to the 1 month follow up (30 days post completion of treatment visit 6) was calculated below. Time points week 6, and the 1 month follow up were included to calculate percent change.
Time Frame 1 Month Follow Up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sham tDCS Stimulation Anodal tDCS Stimulation of DLPFC
Hide Arm/Group Description:

30 minutes of the sham transcranial Direct Current Stimulation

Transcranial Direct Current Stimulation: Transcranial Direct Current Stimulation is a minimally invasive technique that uses a small amount of electricity (2mA) to temporarily stimulate specific brain areas in awake people.

30 minutes of the active transcranial Direct Current Stimulation (tDCS)

Transcranial Direct Current Stimulation: Transcranial Direct Current Stimulation is a minimally invasive technique that uses a small amount of electricity (2mA) to temporarily stimulate specific brain areas in awake people.

Overall Number of Participants Analyzed 5 5
Mean (Standard Deviation)
Unit of Measure: percent change
-36.11  (29.33) -23.71  (28.74)
15.Secondary Outcome
Title Percent Change in Average Daily Pain at 3 Month Follow Up
Hide Description Participants were asked to rate their pain on average every day for 60 days, post 1 month follow up visit. Average pain ratings were on 0-10 scale. 0=No Pain at all and 10=Extreme Pain. The 3 Month Follow Up included 60 Daily Pain ratings (Collected Post 1 Month Follow Up) that were averaged. The change in average daily pain ratings from the 1 month follow up (30 days post completion of treatment visit 6) to the 3 Month Follow Up (60 days post completion of the 1 month follow up visit) was calculated below. Time points 1 month follow up, and 3 month follow up were included to calculate percent change.
Time Frame 3 Month Follow Up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sham tDCS Stimulation Anodal tDCS Stimulation of DLPFC
Hide Arm/Group Description:

30 minutes of the sham transcranial Direct Current Stimulation

Transcranial Direct Current Stimulation: Transcranial Direct Current Stimulation is a minimally invasive technique that uses a small amount of electricity (2mA) to temporarily stimulate specific brain areas in awake people.

30 minutes of the active transcranial Direct Current Stimulation (tDCS)

Transcranial Direct Current Stimulation: Transcranial Direct Current Stimulation is a minimally invasive technique that uses a small amount of electricity (2mA) to temporarily stimulate specific brain areas in awake people.

Overall Number of Participants Analyzed 4 4
Mean (Standard Deviation)
Unit of Measure: percent change
-31.15  (42.72) -48.93  (37.73)
16.Secondary Outcome
Title Affective Subscale of McGill Pain Questionnaire at 1 Month Follow Up
Hide Description Participants completed the McGill Pain Questionnaire-short form (MPQ) at Baseline. The possible total range of scores is 0 to 45. The MPQ has two pain dimensions: 1.Sensory subscale with 11 words, and 2.Affective subscale with 4 words from the original MPQ. The range of scores for the sensory dimension of pain is 0-33. The data below report the mean score for the affective subscale of the McGill Pain Questionnaire for both groups. The range of scores for the affective subscale being 0-12 with Higher scores indicating worse pain.
Time Frame 1 Month Follow Up
Hide Outcome Measure Data
Hide Analysis Population Description

3 Sham tDCS Participants dropped out leaving 5 total participants in Sham group.

2 Anodal tDCS Participants dropped out leaving 5 total participants in Anodal group.

Arm/Group Title Sham tDCS Stimulation Anodal tDCS Stimulation of DLPFC
Hide Arm/Group Description:

30 minutes of the sham transcranial Direct Current Stimulation

Transcranial Direct Current Stimulation: Transcranial Direct Current Stimulation is a minimally invasive technique that uses a small amount of electricity (2mA) to temporarily stimulate specific brain areas in awake people.

30 minutes of the active transcranial Direct Current Stimulation (tDCS)

Transcranial Direct Current Stimulation: Transcranial Direct Current Stimulation is a minimally invasive technique that uses a small amount of electricity (2mA) to temporarily stimulate specific brain areas in awake people.

Overall Number of Participants Analyzed 5 5
Mean (Standard Deviation)
Unit of Measure: units on a scale
4.2  (2.64) 5.0  (3.29)
17.Secondary Outcome
Title The Short-Form 12 Healthy Survey at 1 Month Follow Up
Hide Description To assess each participant's mental and physical functioning at the 1 Month Follow Up visit, The Short-Form 12 Healthy Survey (SF-12) will be administered. The SF-12 is a multipurpose short form survey with 12 questions, all selected from the SF-36 Health Survey (Ware, Kosinski, and Keller, 1996). The questions were combined, scored, and weighted to create two scales that provide glimpses into mental and physical functioning and overall health-related-quality of life. Total score range for the summary scores = 0-100, where higher score represents higher level of functioning.
Time Frame 1 Month Follow Up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sham tDCS Stimulation Anodal tDCS Stimulation of DLPFC
Hide Arm/Group Description:

30 minutes of the sham transcranial Direct Current Stimulation

Transcranial Direct Current Stimulation: Transcranial Direct Current Stimulation is a minimally invasive technique that uses a small amount of electricity (2mA) to temporarily stimulate specific brain areas in awake people.

30 minutes of the active transcranial Direct Current Stimulation (tDCS)

Transcranial Direct Current Stimulation: Transcranial Direct Current Stimulation is a minimally invasive technique that uses a small amount of electricity (2mA) to temporarily stimulate specific brain areas in awake people.

Overall Number of Participants Analyzed 5 5
Mean (Standard Deviation)
Unit of Measure: units on a scale
29.60  (2.61) 31.20  (1.92)
18.Secondary Outcome
Title The Fibromyalgia (FM) Impact Questionnaire at 1 Month Follow Up
Hide Description To assess the impact of fibromyalgia on each participant's function at the 1 Month Follow Up visit, The Fibromyalgia (FM) Impact Questionnaire will be administered. The FM assesses the following symptoms; physical Impairment, well-being, pain, fatigue, rested, stiffness, anxiety, and depression within the past 24 hours. Each symptom scale ranges from 0 to 10. For example, 0=no pain and 10=extreme pain, 0=not fatigued and 10=extremely fatigued. The final score is the total score which ranges from 0 to 80. Higher scores indicate greater impact of fibromyalgia on functioning.
Time Frame 1 Month Follow Up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sham tDCS Stimulation Anodal tDCS Stimulation of DLPFC
Hide Arm/Group Description:

30 minutes of the sham transcranial Direct Current Stimulation

Transcranial Direct Current Stimulation: Transcranial Direct Current Stimulation is a minimally invasive technique that uses a small amount of electricity (2mA) to temporarily stimulate specific brain areas in awake people.

30 minutes of the active transcranial Direct Current Stimulation (tDCS)

Transcranial Direct Current Stimulation: Transcranial Direct Current Stimulation is a minimally invasive technique that uses a small amount of electricity (2mA) to temporarily stimulate specific brain areas in awake people.

Overall Number of Participants Analyzed 5 5
Mean (Standard Deviation)
Unit of Measure: units on a scale
3.31  (1.51) 2.69  (1.23)
Time Frame 2 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Sham tDCS Stimulation Anodal tDCS Stimulation of DLPFC
Hide Arm/Group Description

30 minutes of the sham transcranial Direct Current Stimulation

Transcranial Direct Current Stimulation: Transcranial Direct Current Stimulation is a minimally invasive technique that uses a small amount of electricity (2mA) to temporarily stimulate specific brain areas in awake people.

30 minutes of the active transcranial Direct Current Stimulation (tDCS)

Transcranial Direct Current Stimulation: Transcranial Direct Current Stimulation is a minimally invasive technique that uses a small amount of electricity (2mA) to temporarily stimulate specific brain areas in awake people.

All-Cause Mortality
Sham tDCS Stimulation Anodal tDCS Stimulation of DLPFC
Affected / at Risk (%) Affected / at Risk (%)
Total   0/8 (0.00%)   0/7 (0.00%) 
Hide Serious Adverse Events
Sham tDCS Stimulation Anodal tDCS Stimulation of DLPFC
Affected / at Risk (%) Affected / at Risk (%)
Total   0/8 (0.00%)   0/7 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Sham tDCS Stimulation Anodal tDCS Stimulation of DLPFC
Affected / at Risk (%) Affected / at Risk (%)
Total   0/8 (0.00%)   0/7 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Jeffrey Borckardt
Organization: Medical University of South Carolina
Phone: 843-792-3295
EMail: borckard@musc.edu
Layout table for additonal information
Responsible Party: Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT02723175    
Other Study ID Numbers: Pro00039603
1R21AR066428-01 ( U.S. NIH Grant/Contract )
First Submitted: December 14, 2015
First Posted: March 30, 2016
Results First Submitted: May 23, 2018
Results First Posted: November 28, 2018
Last Update Posted: November 28, 2018