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

This study is currently recruiting participants.
Verified April 2014 by Spaulding Rehabilitation Hospital
Sponsor:
Collaborator:
U.S. Department of Education
Information provided by (Responsible Party):
Felipe Fregni, Spaulding Rehabilitation Hospital
ClinicalTrials.gov Identifier:
NCT01795079
First received: February 15, 2013
Last updated: April 14, 2014
Last verified: April 2014
  Purpose

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 Intervention Phase
Burn Injury
Chronic Pain
Pruritus
Itching
Device: Transcranial direct current stimulation (tDCS)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Spaulding Rehabilitation Hospital:

Primary Outcome Measures:
  • Change in Pain Scale [ Time Frame: Approximately one year ] [ Designated as safety issue: No ]
    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) from baseline to follow-up (up to 7 months after the final stimulation session).


Secondary Outcome Measures:
  • Change in Depression Scale [ Time Frame: Approximately one year ] [ Designated as safety issue: No ]
    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), from baseline to follow-up (up to 7 months after the final stimulation session).

  • Change in Post-Traumatic Stress Symptoms Scale [ Time Frame: Approximately one year ] [ Designated as safety issue: No ]
    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), from baseline to follow-up (up to 7 months after the final stimulation session).

  • Change in Anxiety Scale [ Time Frame: Approximately one year ] [ Designated as safety issue: No ]
    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), from baseline to follow-up (up to 7 months after the final stimulation session).

  • Change in Itch Severity/Activity Scale [ Time Frame: Approximately one year ] [ Designated as safety issue: No ]
    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) from baseline to follow-up (up to 7 months after the final stimulation session).


Other Outcome Measures:
  • Change in Quality of Life Scale [ Time Frame: Approximately one year ] [ Designated as safety issue: No ]
    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), from baseline to follow-up (up to 7 months after the final stimulation session).

  • Change in Community Integration Scale [ Time Frame: Approximately one year ] [ Designated as safety issue: No ]
    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), from baseline to follow-up (up to 7 months after the final stimulation session).


Estimated Enrollment: 60
Study Start Date: January 2013
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01795079

Contacts
Contact: Felipe Fregni, MD PhD MPH 617-952-6151 ffregni@partners.org
Contact: Kayleen M Weaver, BA 617-952-6156 kmweaver@partners.org

Locations
United States, Massachusetts
Spaulding Rehabilitation Hospital Recruiting
Boston, Massachusetts, United States, 02129
Sponsors and Collaborators
Spaulding Rehabilitation Hospital
U.S. Department of Education
Investigators
Principal Investigator: Felipe Fregni, MD PhD MPH Spaulding Rehabilitation Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: Felipe Fregni, Associate Professor, Spaulding Rehabilitation Hospital
ClinicalTrials.gov Identifier: NCT01795079     History of Changes
Other Study ID Numbers: 2012-p-001996
Study First Received: February 15, 2013
Last Updated: April 14, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Spaulding Rehabilitation Hospital:
transcranial stimulation
direct current

Additional relevant MeSH terms:
Burns
Pruritus
Wounds and Injuries
Skin Diseases
Skin Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on April 22, 2014