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Transcranial Direct Stimulation in Chronic Pelvic Pain

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ClinicalTrials.gov Identifier: NCT01143636
Recruitment Status : Completed
First Posted : June 14, 2010
Results First Posted : March 15, 2017
Last Update Posted : March 15, 2017
Sponsor:
Information provided by (Responsible Party):
Felipe Fregni, Spaulding Rehabilitation Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Pelvic Pain
Healthy
Intervention Device: Transcranial Direct Current Stimulation
Enrollment 35
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Pelvic Pain, Active tDCS Pelvic Pain, Sham tDCS Healthy Controls: Active tDCS/Sham tDCS Healthy Subjects: Sham tDCS/Active tDCS
Hide Arm/Group Description Experimental Group: Subjects received a total of 10 consecutive sessions of active tDCS over a two-week period (administered Monday - Friday). During each session, the anode electrode was placed over the primary motor cortex of the predominantly painful side. tDCS was delivered for 20 minutes at an intensity of 2mA. In the active group current was applied for the full 20 minutes. Sham Comparator: Subjects received a total of 10 consecutive sessions of sham tDCS over a two-week period (administered Mon-Fri). During each session, the anode was placed over the primary motor cortex of the predominantly painful side. Each tDCS session lasts 20 minutes. However, during sham stimulation current was only applied for 30 seconds at an intensity of 2mA. Healthy Controls: These subjects received one single session of active tDCS and one one single session of sham tDCS. There was a time interval of at least one week in between the randomized stimulation sessions to prevent a carryover effect. This group received active stimulation first. Subjects received stimulation for 20 minutes at an intensity of 2mA. In the sham condition, current was only applied for the first 30 seconds and remained off for the rest of the 20 minute period. Healthy Controls: These subjects received one single session of sham tDCS and one single session of active tDCS. There was a time interval of at least one week in between the randomized stimulation sessions to prevent a carryover effect. This group received sham stimulation first. Subjects received stimulation for 20 minutes at an intensity of 2mA. In the sham condition, current was only applied for the first 30 seconds and remained off for the rest of the 20 minute period.
Period Title: Overall Study
Started 6 5 8 7
Completed 5 4 8 7
Not Completed 1 1 0 0
Arm/Group Title Active tDCS - Pelvic Pain Sham tDCS - Pelvic Pain Active tDCS&Sham tDCS - Healthy Controls Total
Hide Arm/Group Description Experimental Group: Subjects received a total of 10 consecutive sessions of active tDCS over a two-week period (administered Monday - Friday). During each session, the anode electrode was placed over the primary motor cortex of the predominantly painful side. tDCS was delivered for 20 minutes at an intensity of 2mA. In the active group current was applied for the full 20 minutes. Sham Comparator: Subjects received a total of 10 consecutive sessions of sham tDCS over a two-week period (administered Mon-Fri). During each session, the anode was placed over the primary motor cortex of the predominantly painful side. Each tDCS session lasts 20 minutes. However, during sham stimulation current was only applied for 30 seconds at an intensity of 2mA. Healthy Controls: These subjects received one single session of active tDCS and one one single session of sham tDCS. There was a time interval of at least one week in between the randomized stimulation sessions to prevent a carryover effect. This group received active stimulation first. Subjects received stimulation for 20 minutes at an intensity of 2mA. In the sham condition, current was only applied for the first 30 seconds and remained off for the rest of the 20 minute period. Total of all reporting groups
Overall Number of Baseline Participants 6 5 15 26
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 5 participants 15 participants 26 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
6
 100.0%
5
 100.0%
15
 100.0%
26
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Sex/Gender, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 6 participants 5 participants 15 participants 26 participants
Female 5 4 9 18
Male 1 1 6 8
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 6 participants 5 participants 15 participants 26 participants
6 5 15 26
1.Primary Outcome
Title Pain Assessment
Hide Description We use the Visual analogue scale (VAS) to measure pain. The VAS is ranged from 0 to 10, with 0 reffering to no pain and 10 reffering the the worst possible pain. We used the difference between post treatment minus baseline to compare the two treatments (active versus sham tDCS).
Time Frame baseline and at 2 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The VAS is performed in patients with pelvic pain (Experiment 1).
Arm/Group Title Pelvic Pain, Active tDCS Pelvic Pain, Sham tDCS
Hide Arm/Group Description:
Experimental Group: Subjects received a total of 20 consecutive sessions of active tDCS over a four-week period (administered Monday - Friday). During each session, the anode electrode was placed over the primary motor cortex of the predominantly painful side. tDCS was delivered for 20 minutes at an intensity of 2mA. In the active group current was applied for the full 20 minutes.
Sham Comparator: Subjects received a total of 20 consecutive sessions of sham tDCS over a four-week period (administered Mon-Fri). During each session, the anode was placed over the primary motor cortex of the predominantly painful side. Each tDCS session lasts 20 minutes. However, during sham stimulation current was only applied for 30 seconds at an intensity of 2mA.
Overall Number of Participants Analyzed 5 4
Mean (Standard Deviation)
Unit of Measure: units on a scale
-2.375  (1.79) -1.625  (2.46)
2.Primary Outcome
Title Pressure Pain Threshold
Hide Description

Pressure pain threshold (PPT) is defined as the minimum force applied which induces pain.

The change in pressure pain threshold (post minus pre intervention) is use for the analysis.

Time Frame baseline and at 2 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The pain pressure test is performed in healthy participants (exp 2).
Arm/Group Title Healthy Controls: Active tDCS Healthy Subjects: Sham tDCS
Hide Arm/Group Description:
Healthy Controls: These subjects received one single session of active tDCS and one one single session of sham tDCS. There was a time interval of at least one week in between the randomized stimulation sessions to prevent a carryover effect. This group received active stimulation first. Subjects received stimulation for 20 minutes at an intensity of 2mA. In the sham condition, current was only applied for the first 30 seconds and remained off for the rest of the 20 minute period.
Healthy Controls: These subjects received one single session of sham tDCS and one single session of active tDCS. There was a time interval of at least one week in between the randomized stimulation sessions to prevent a carryover effect. This group received sham stimulation first. Subjects received stimulation for 20 minutes at an intensity of 2mA. In the sham condition, current was only applied for the first 30 seconds and remained off for the rest of the 20 minute period.
Overall Number of Participants Analyzed 15 15
Mean (Standard Deviation)
Unit of Measure: lb
1.25  (0.75) -1  (0.5)
3.Secondary Outcome
Title Quality of Life Scale (QOLS)
Hide Description The questionnaire on quality of life was performed at the end of the treatment session and compared between the two groups (active and sham) in patients with pelvic pain (Exp. 1). The QOLS has 16 items (total scores ranging from 16 to 112) the highest scores corresponding the best QOL.
Time Frame 2 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
We compared active and sham groups (Exp. 1)
Arm/Group Title Pelvic Pain, Active tDCS Pelvic Pain, Sham tDCS
Hide Arm/Group Description:
Experimental Group: Subjects received a total of 20 consecutive sessions of active tDCS over a four-week period (administered Monday - Friday). During each session, the anode electrode was placed over the primary motor cortex of the predominantly painful side. tDCS was delivered for 20 minutes at an intensity of 2mA. In the active group current was applied for the full 20 minutes.
Sham Comparator: Subjects received a total of 20 consecutive sessions of sham tDCS over a four-week period (administered Mon-Fri). During each session, the anode was placed over the primary motor cortex of the predominantly painful side. Each tDCS session lasts 20 minutes. However, during sham stimulation current was only applied for 30 seconds at an intensity of 2mA.
Overall Number of Participants Analyzed 5 4
Mean (Standard Deviation)
Unit of Measure: units on a scale
81.2  (15.4) 78  (11.43)
4.Secondary Outcome
Title Clinical Global Impression - CGI
Hide Description This scale measures illness severity and was performed on patients with pelvic pain (Exp. 1). The scale was performed at end of the treatment and compared between the two groups (real and sham). The scale is divided in 3 sub-scales: Severity of illness (0-7), global improvement (0-7) and efficacy index (0-16), total scores ranging from 0 to 30. The highest scores corresponding to lowest clinical improvement.
Time Frame 2 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients with pelvic pain (Exp 1)
Arm/Group Title Pelvic Pain, Active tDCS Pelvic Pain, Sham tDCS
Hide Arm/Group Description:
Experimental Group: Subjects received a total of 20 consecutive sessions of active tDCS over a four-week period (administered Monday - Friday). During each session, the anode electrode was placed over the primary motor cortex of the predominantly painful side. tDCS was delivered for 20 minutes at an intensity of 2mA. In the active group current was applied for the full 20 minutes.
Sham Comparator: Subjects received a total of 20 consecutive sessions of sham tDCS over a four-week period (administered Mon-Fri). During each session, the anode was placed over the primary motor cortex of the predominantly painful side. Each tDCS session lasts 20 minutes. However, during sham stimulation current was only applied for 30 seconds at an intensity of 2mA.
Overall Number of Participants Analyzed 5 4
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.8  (0.4) 3.3  (1.2)
5.Secondary Outcome
Title Visual Analogue Scale - Anxiety.This Scale Measures Patients' Level of Anxiety on a Scale (0-no Anxiety to 10-worst Anxiety Ever). It Was Performed at the End of the Treatment and Compared Between the 2 Groups (Real and Sham) in Patients With Pelvic Pain
Hide Description The scale was performed at the end of the treatment and compared between the 2 groups (real and sham) in patients with pelvic pain (Exp. 1).
Time Frame 2 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
This outcome measure was performed in patients with pelvic pain (Exp 1).
Arm/Group Title Pelvic Pain, Active tDCS Pelvic Pain, Sham tDCS
Hide Arm/Group Description:
Experimental Group: Subjects received a total of 20 consecutive sessions of active tDCS over a four-week period (administered Monday - Friday). During each session, the anode electrode was placed over the primary motor cortex of the predominantly painful side. tDCS was delivered for 20 minutes at an intensity of 2mA. In the active group current was applied for the full 20 minutes.
Sham Comparator: Subjects received a total of 20 consecutive sessions of sham tDCS over a four-week period (administered Mon-Fri). During each session, the anode was placed over the primary motor cortex of the predominantly painful side. Each tDCS session lasts 20 minutes. However, during sham stimulation current was only applied for 30 seconds at an intensity of 2mA.
Overall Number of Participants Analyzed 5 4
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.8  (0.9) 2.5  (2.1)
6.Secondary Outcome
Title Mini Mental Scale - MMS
Hide Description This scale measures patients cognitive impairment. It was performed at the end of the treatment and compared between the 2 groups (real and sham) in patients with pelvic pain (Exp. 1). It is a 30 points scale (total scores ranging from 0 to 30), the highest score corresponds to the highest cognitive status.
Time Frame 2 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients with pelvic pain (Exp. 1).
Arm/Group Title Pelvic Pain, Active tDCS Pelvic Pain, Sham tDCS
Hide Arm/Group Description:
Experimental Group: Subjects received a total of 20 consecutive sessions of active tDCS over a four-week period (administered Monday - Friday). During each session, the anode electrode was placed over the primary motor cortex of the predominantly painful side. tDCS was delivered for 20 minutes at an intensity of 2mA. In the active group current was applied for the full 20 minutes.
Sham Comparator: Subjects received a total of 20 consecutive sessions of sham tDCS over a four-week period (administered Mon-Fri). During each session, the anode was placed over the primary motor cortex of the predominantly painful side. Each tDCS session lasts 20 minutes. However, during sham stimulation current was only applied for 30 seconds at an intensity of 2mA.
Overall Number of Participants Analyzed 5 4
Mean (Standard Deviation)
Unit of Measure: units on a scale
29.4  (0.8) 28.75  (1.1)
7.Secondary Outcome
Title Beck Depression Inventory - BDI.
Hide Description BDI is a questionnaire used for detecting depression. It was performed at the end of the treatment and compared between the 2 groups (real and sham) in patients with pelvic pain (Exp. 1). It is a 21-question multiple-choice self-report inventory (scores ranging from 0 to 63 - 0 corresponds to no symptom of depression).
Time Frame 2 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients with pelvic pain (Exp. 1).
Arm/Group Title Pelvic Pain, Active tDCS Pelvic Pain, Sham tDCS
Hide Arm/Group Description:
Experimental Group: Subjects received a total of 20 consecutive sessions of active tDCS over a four-week period (administered Monday - Friday). During each session, the anode electrode was placed over the primary motor cortex of the predominantly painful side. tDCS was delivered for 20 minutes at an intensity of 2mA. In the active group current was applied for the full 20 minutes.
Sham Comparator: Subjects received a total of 20 consecutive sessions of sham tDCS over a four-week period (administered Mon-Fri). During each session, the anode was placed over the primary motor cortex of the predominantly painful side. Each tDCS session lasts 20 minutes. However, during sham stimulation current was only applied for 30 seconds at an intensity of 2mA.
Overall Number of Participants Analyzed 5 4
Mean (Standard Deviation)
Unit of Measure: units on a scale
10  (9.7) 6.75  (6.8)
8.Secondary Outcome
Title Patient Global Assessment - PGA
Hide Description This scale measures patient's assessment of general health. It was performed at the end of the treatment and compared between the 2 groups (real and sham) in patients with pelvic pain (Exp 1). The patient has to answer the question "how is your health overall" on a scale going from 0 to 10 (0 being the worst, 10 being the best).
Time Frame 2 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients with pelvic pain (Exp. 1).
Arm/Group Title Pelvic Pain, Active tDCS Pelvic Pain, Sham tDCS
Hide Arm/Group Description:
Experimental Group: Subjects received a total of 20 consecutive sessions of active tDCS over a four-week period (administered Monday - Friday). During each session, the anode electrode was placed over the primary motor cortex of the predominantly painful side. tDCS was delivered for 20 minutes at an intensity of 2mA. In the active group current was applied for the full 20 minutes.
Sham Comparator: Subjects received a total of 20 consecutive sessions of sham tDCS over a four-week period (administered Mon-Fri). During each session, the anode was placed over the primary motor cortex of the predominantly painful side. Each tDCS session lasts 20 minutes. However, during sham stimulation current was only applied for 30 seconds at an intensity of 2mA.
Overall Number of Participants Analyzed 5 4
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.8  (0.9) 2.75  (1.3)
9.Secondary Outcome
Title Von Frey
Hide Description This test is used to test subjects' sensitivity to a mechanical stimulus. It was performed before and and after the treatment and the difference (post minus pre) was compared between the 2 groups (real and sham) in patients with pelvic pain (Exp. 1). A set of filaments, typically from 0.008 grams force up to 300 grams force, is applied on the patients' skin. The mechanical threshold is defined as the moment when the patient detects the stimulus.
Time Frame baseline and at 2 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients with pelvic pain (Exp. 1).
Arm/Group Title Pelvic Pain, Active tDCS Pelvic Pain, Sham tDCS
Hide Arm/Group Description:
Experimental Group: Subjects received a total of 20 consecutive sessions of active tDCS over a four-week period (administered Monday - Friday). During each session, the anode electrode was placed over the primary motor cortex of the predominantly painful side. tDCS was delivered for 20 minutes at an intensity of 2mA. In the active group current was applied for the full 20 minutes.
Sham Comparator: Subjects received a total of 20 consecutive sessions of sham tDCS over a four-week period (administered Mon-Fri). During each session, the anode was placed over the primary motor cortex of the predominantly painful side. Each tDCS session lasts 20 minutes. However, during sham stimulation current was only applied for 30 seconds at an intensity of 2mA.
Overall Number of Participants Analyzed 5 4
Mean (Standard Deviation)
Unit of Measure: grams
0.7  (0.76) -0.29  (0.48)
10.Secondary Outcome
Title Pain Pressure Threshold Test - PPT
Hide Description Pressure pain threshold (PPT) is defined as the minimum force applied which induces pain.This test was applied before and after the treatment and the difference (post minus pre) was compared between the 2 groups (real and sham) in patients with pelvic pain (Exp 1).
Time Frame baseline and at 2 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients with pelvic pain (Exp. 1).
Arm/Group Title Pelvic Pain, Active tDCS Pelvic Pain, Sham tDCS
Hide Arm/Group Description:
Experimental Group: Subjects received a total of 20 consecutive sessions of active tDCS over a four-week period (administered Monday - Friday). During each session, the anode electrode was placed over the primary motor cortex of the predominantly painful side. tDCS was delivered for 20 minutes at an intensity of 2mA. In the active group current was applied for the full 20 minutes.
Sham Comparator: Subjects received a total of 20 consecutive sessions of sham tDCS over a four-week period (administered Mon-Fri). During each session, the anode was placed over the primary motor cortex of the predominantly painful side. Each tDCS session lasts 20 minutes. However, during sham stimulation current was only applied for 30 seconds at an intensity of 2mA.
Overall Number of Participants Analyzed 5 4
Mean (Standard Deviation)
Unit of Measure: lb
2.21  (3.93) 1.41  (2.31)
11.Secondary Outcome
Title Diffuse Noxious Inhibitory Controls - DNIC.
Hide Description DNIC occurs when response from a painful stimulus (pain pressure threshold - PPT) is inhibited by another noxious stimulus (cold water). The difference between baseline and post treatment was compared between the 2 groups (real and sham) in patients with pelvic pain (Exp. 1).
Time Frame baseline and at 2 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
patients with pelvic pain (Exp. 1).
Arm/Group Title Pelvic Pain, Active tDCS Pelvic Pain, Sham tDCS
Hide Arm/Group Description:
Experimental Group: Subjects received a total of 20 consecutive sessions of active tDCS over a four-week period (administered Monday - Friday). During each session, the anode electrode was placed over the primary motor cortex of the predominantly painful side. tDCS was delivered for 20 minutes at an intensity of 2mA. In the active group current was applied for the full 20 minutes.
Sham Comparator: Subjects received a total of 20 consecutive sessions of sham tDCS over a four-week period (administered Mon-Fri). During each session, the anode was placed over the primary motor cortex of the predominantly painful side. Each tDCS session lasts 20 minutes. However, during sham stimulation current was only applied for 30 seconds at an intensity of 2mA.
Overall Number of Participants Analyzed 5 4
Mean (Standard Deviation)
Unit of Measure: lb
2.46  (4.84) 0.66  (2.39)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title SHAM tDCS - Pelvic Pain Patients ACTIVE tDCS - Pelvic Pain Patients SHAM tDCS - Healthy ACTIVE tDCS - Sham
Hide Arm/Group Description

SHAM tDCS: Subjects will receive a total of 10 consecutive sessions of sham tDCS. During each session, the anode electrode will be placed on the primary motor cortex of the predominant painful side.

For sham-controlled tDCS subjects, the current will be applied only for 30 seconds.

Transcranial Direct Current Stimulation: Stimulation will be given at 2 mA for a period of 20 minutes.

ACTIVE tDCS: Subjects will receive a total of 10 consecutive sessions of active tDCS. During each session, the anode electrode will be placed on the primary motor cortex of the predominant painful side.

Transcranial Direct Current Stimulation: Stimulation will be given at 2 mA for a period of 20 minutes.

SHAM tDCS: Subjects will receive a single session of sham tDCS. The anode electrode will be placed on the primary motor cortex.

For sham-controlled tDCS subjects, the current will be applied only for 30 seconds.

Transcranial Direct Current Stimulation: Stimulation will be given at 2 mA for a period of 20 minutes.

ACTIVE tDCS: Subjects will receive a single session of active tDCS. The anode electrode will be placed on the primary motor cortex.

Transcranial Direct Current Stimulation: Stimulation will be given at 2 mA for a period of 20 minutes.

All-Cause Mortality
SHAM tDCS - Pelvic Pain Patients ACTIVE tDCS - Pelvic Pain Patients SHAM tDCS - Healthy ACTIVE tDCS - Sham
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
SHAM tDCS - Pelvic Pain Patients ACTIVE tDCS - Pelvic Pain Patients SHAM tDCS - Healthy ACTIVE tDCS - Sham
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/4 (0.00%)   0/5 (0.00%)   0/15 (0.00%)   0/15 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
SHAM tDCS - Pelvic Pain Patients ACTIVE tDCS - Pelvic Pain Patients SHAM tDCS - Healthy ACTIVE tDCS - Sham
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/4 (75.00%)   5/5 (100.00%)   11/15 (73.33%)   15/15 (100.00%) 
General disorders         
Nausea   0/4 (0.00%)  1/5 (20.00%)  0/15 (0.00%)  0/15 (0.00%) 
Nervous system disorders         
Headache   1/4 (25.00%)  1/5 (20.00%)  1/15 (6.67%)  1/15 (6.67%) 
Neck pain   1/4 (25.00%)  1/5 (20.00%)  0/15 (0.00%)  0/15 (0.00%) 
Sleepiness   1/4 (25.00%)  3/5 (60.00%)  6/15 (40.00%)  5/15 (33.33%) 
Diziness   2/4 (50.00%)  0/5 (0.00%)  0/15 (0.00%)  0/15 (0.00%) 
Trouble concentrating   0/4 (0.00%)  1/5 (20.00%)  0/15 (0.00%)  0/15 (0.00%) 
Acute mood change   0/4 (0.00%)  1/5 (20.00%)  0/15 (0.00%)  0/15 (0.00%) 
Skin and subcutaneous tissue disorders         
Tingling   3/4 (75.00%)  5/5 (100.00%)  10/15 (66.67%)  11/15 (73.33%) 
Skin redness   2/4 (50.00%)  4/5 (80.00%)  8/15 (53.33%)  7/15 (46.67%) 
Scalp burning sensation   0/4 (0.00%)  1/5 (20.00%)  0/15 (0.00%)  1/15 (6.67%) 
Itching   0/4 (0.00%)  1/5 (20.00%)  1/15 (6.67%)  2/15 (13.33%) 
Indicates events were collected by systematic assessment
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
Name/Title: Dr. Felipe Fregni, Director of the Laboratory of Neuromodulation
Organization: Spaulding Rehabilitation Hospital, Boston, MA.
Phone: 617.952.6153
Responsible Party: Felipe Fregni, Spaulding Rehabilitation Hospital
ClinicalTrials.gov Identifier: NCT01143636     History of Changes
Other Study ID Numbers: 2009-P-002048
First Submitted: April 20, 2010
First Posted: June 14, 2010
Results First Submitted: August 4, 2014
Results First Posted: March 15, 2017
Last Update Posted: March 15, 2017