Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effects of Transcranial Direct Current Stimulation (tDCS) on Neuropathic Symptoms Following Burn Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01795079
Recruitment Status : Completed
First Posted : February 20, 2013
Results First Posted : March 17, 2021
Last Update Posted : March 17, 2021
Sponsor:
Collaborator:
U.S. Department of Education
Information provided by (Responsible Party):
Felipe Fregni, Spaulding Rehabilitation Hospital

Brief Summary:

The purpose of this study is to see the effects of transcranial direct current stimulation (tDCS) on the pain and itching associated with burn injury. This study is part of the Boston-Harvard Burn Model System. The investigators hypothesize that there will be a decrease in pain levels with active stimulation, when compared to sham stimulation, using a 3 week stimulation schedule- 2 weeks of stimulation (10 consecutive days) followed by 1 week of stimulation (5 consecutive days) after three follow up visits at 2, 4 and 8 weeks after initial course of stimulation. The subject will also have follow ups at 2, 4 and 8 weeks after the second course of stimulation.

If a subject receives sham during the experiment, he/she may enroll in an open-label portion of the study and receive 10 days of active stimulation.


Condition or disease Intervention/treatment Phase
Burn Injury Chronic Pain Pruritus Itching Device: Transcranial direct current stimulation (tDCS) Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Boston-Harvard Burn Injury Model System: Cortical Modulation With Transcranial Direct Current Stimulation (tDCS) for Neuropathic Symptoms Following Burn Injury
Study Start Date : January 2013
Actual Primary Completion Date : July 2019
Actual Study Completion Date : April 15, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Burns Itching

Arm Intervention/treatment
Experimental: Active tDCS
Subjects will undergo 20 minutes active tDCS.
Device: Transcranial direct current stimulation (tDCS)
Subjects will undergo 15 sessions of tDCS stimulation (either active or sham), 1x per day at 20 minutes per session.
Other Names:
  • 1x1 low-intensity direct current stimulator
  • Soterix Medical

Sham Comparator: Sham tDCS
Subjects will undergo 20 minutes of sham stimulation.
Device: Transcranial direct current stimulation (tDCS)
Subjects will undergo 15 sessions of tDCS stimulation (either active or sham), 1x per day at 20 minutes per session.
Other Names:
  • 1x1 low-intensity direct current stimulator
  • Soterix Medical




Primary Outcome Measures :
  1. Change in Pain Scale [ Time Frame: 2 weeks ]
    Determine whether anodal transcranial direct current stimulation is effective in reducing pain in subjects with neuropathic pain due to burn injury, as measured by changes in the Brief Pain Inventory (BPI). Brief Pain Inventory (BPI) consist consists of a 9 part questionnaire. The questions include the severity of pain levels (worst, least, average, & current), the impact of pain on daily functioning in different areas (mood, walking, relationships, sleep, normal work, & general activity), current treatments and perceived effectiveness of current treatments. The VAS Pain scale is a simple 10- point scale (0 = ''no pain'', 10 = ''pain as bad as you can imagine'') measuring patients' worst pain and least pain, on average and at present time.

  2. Change in Itch Severity/Activity Scale [ Time Frame: 2 weeks ]
    Determine whether anodal transcranial direct current stimulation is effective in reducing itch severity/activity in subjects with neuropathic itching due to burn injury, as measured by changes in the Visual Analog Scale (VAS) .This is a 0 to 10 scale, where 0 indicates no intensity and a 10 indicates unbearable intensity of itching.


Secondary Outcome Measures :
  1. Change in Depression Scale [ Time Frame: 2 weeks ]
    Determine whether anodal transcranial direct current stimulation is effective in decreasing severity of depression in subjects with neuropathic pain and itching due to burn injury, as measured by changes in the Beck Depression Inventory (BDI). The Beck Depression Inventory (BDI) contains 21 questions, each answer being scored on a scale value of 0 to 3 (total from 0-63). Higher total scores indicate more severe depressive symptoms.

  2. Change in Post-Traumatic Stress Symptoms Scale [ Time Frame: 2 weeks ]
    Determine whether anodal transcranial direct current stimulation is effective in decreasing post-traumatic stress symptoms in subjects with neuropathic pain and itching due to burn injury, as measured by changes in the Impact of Event Scale Revised (IES-R).This 22-item scale is designed to measure severity of PTS symptoms associated with a traumatic event. Subjects rate their level of distress associated with the event on a 0-4 scale (0 means not at all distressed, 4 means extremely distressed). The IES-R yields a total score (ranging from 0 to 88) where higher scores represent higher stress

  3. Change in Anxiety Scale [ Time Frame: 2 weeks ]
    Determine whether anodal transcranial direct current stimulation is effective in decreasing severity of anxiety in subjects with neuropathic pain and itching due to burn injury, as measured by changes in the Visual Analog Scale (VAS).This is a self-evaluation scale that ranges from 0 to 10, where 0 means no anxiety and 10 means the worst anxiety ever.


Other Outcome Measures:
  1. Change in Quality of Life Scale [ Time Frame: 2 weeks ]
    Determine whether anodal transcranial direct current stimulation is effective in increasing quality of life in subjects with neuropathic pain and itching due to burn injury, as measured by changes in the Veterans RAND 36 Item Health Survey (VR-36). There are eight domains total including: bodily pain, role limitations due to physical problems, physical functioning, general health perception, vitality, social functioning, and role limitations due to mental health issues. Scores for each domain are from 0-100 with a higher score defining a more favorable health outcome.

  2. Change in Community Integration Scale [ Time Frame: 2 weeks ]
    Determine whether anodal transcranial direct current stimulation is effective in increasing community integration functional outcomes in subjects with neuropathic pain and itching due to burn injury, as measured by changes in the Community Integration Questionnaire (CIQ). Total CIQ scores were used as the outcome measure. Contains 15 itms assessing community integrations across three domains (Home integration, social integration, productive activity) . The total score can range from 0 to 29 points (0 - minimal integration to 29 -maximal integration). A positive change indicates an improvement in integration.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Providing informed consent to participate in the study
  • Age 18 or older
  • Burn injury with pain and/or itch that is moderate to severe
  • Burn injury occurring at least 3 weeks prior to enrollment

Exclusion Criteria:

  • Subjects with burns in scalp in the area of electrode placement
  • Psychiatric disorders that have led to hospitalization within the past 6 months or signs of suicidality
  • Learning disorders that may prevent patient's ability to complete assessments
  • Unstable conditions preventing travel to study site
  • Current use of any of the following anti-epileptic medications or dopaminergic medications known to reduce or inhibit the benefits of tDCS treatment: carbamazepine, oxcarbazepine, phenytoin
  • Contraindications to tDCS including implanted metal plates in the head or implanted brain medical devices
  • Pregnancy at time of enrollment
  • History of other neurological conditions associated with structural anatomical changes (i.e. stroke, brain injury, Parkinson's)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01795079


Locations
Layout table for location information
United States, Massachusetts
Spaulding Rehabilitation Hospital
Boston, Massachusetts, United States, 02129
Sponsors and Collaborators
Spaulding Rehabilitation Hospital
U.S. Department of Education
Investigators
Layout table for investigator information
Principal Investigator: Felipe Fregni, MD PhD MPH Spaulding Rehabilitation Hospital
  Study Documents (Full-Text)

Documents provided by Felipe Fregni, Spaulding Rehabilitation Hospital:
Additional Information:
Layout table for additonal information
Responsible Party: Felipe Fregni, Associate Professor, Spaulding Rehabilitation Hospital
ClinicalTrials.gov Identifier: NCT01795079    
Other Study ID Numbers: 2012-p-001996
First Posted: February 20, 2013    Key Record Dates
Results First Posted: March 17, 2021
Last Update Posted: March 17, 2021
Last Verified: February 2021
Keywords provided by Felipe Fregni, Spaulding Rehabilitation Hospital:
transcranial stimulation
direct current
Additional relevant MeSH terms:
Layout table for MeSH terms
Pruritus
Chronic Pain
Wounds and Injuries
Burns
Pain
Neurologic Manifestations
Skin Diseases
Skin Manifestations