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

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ClinicalTrials.gov Identifier: NCT01795079
Recruitment Status : Active, not recruiting
First Posted : February 20, 2013
Last Update Posted : October 25, 2018
Sponsor:
Collaborator:
U.S. Department of Education
Information provided by (Responsible Party):
Felipe Fregni, Spaulding Rehabilitation Hospital

Tracking Information
First Submitted Date  ICMJE February 15, 2013
First Posted Date  ICMJE February 20, 2013
Last Update Posted Date October 25, 2018
Study Start Date  ICMJE January 2013
Estimated Primary Completion Date July 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 15, 2013)
Change in Pain Scale [ Time Frame: Approximately one year ]
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01795079 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 15, 2013)
  • Change in Depression Scale [ Time Frame: Approximately one year ]
    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 ]
    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 ]
    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 ]
    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).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Outcome Measures  ICMJE
 (submitted: February 15, 2013)
  • Change in Quality of Life Scale [ Time Frame: Approximately one year ]
    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 ]
    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).
Original Other Outcome Measures  ICMJE Same as current
 
Descriptive Information
Brief Title  ICMJE Effects of Transcranial Direct Current Stimulation (tDCS) on Neuropathic Symptoms Following Burn Injury
Official Title  ICMJE Boston-Harvard Burn Injury Model System: Cortical Modulation With Transcranial Direct Current Stimulation (tDCS) for Neuropathic Symptoms Following Burn Injury
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Burn Injury
  • Chronic Pain
  • Pruritus
  • Itching
Intervention  ICMJE 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
Study Arms
  • Experimental: Active tDCS
    Subjects will undergo 20 minutes active tDCS.
    Intervention: Device: Transcranial direct current stimulation (tDCS)
  • Sham Comparator: Sham tDCS
    Subjects will undergo 20 minutes of sham stimulation.
    Intervention: Device: Transcranial direct current stimulation (tDCS)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: January 26, 2018)
34
Original Estimated Enrollment  ICMJE
 (submitted: February 15, 2013)
60
Estimated Study Completion Date July 2019
Estimated Primary Completion Date July 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01795079
Other Study ID Numbers  ICMJE 2012-p-001996
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Felipe Fregni, Spaulding Rehabilitation Hospital
Study Sponsor  ICMJE Spaulding Rehabilitation Hospital
Collaborators  ICMJE U.S. Department of Education
Investigators  ICMJE
Principal Investigator: Felipe Fregni, MD PhD MPH Spaulding Rehabilitation Hospital
PRS Account Spaulding Rehabilitation Hospital
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP