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

Primary Purpose

Pain, Burn Injury

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transcranial Direct Current Stimulation (tDCS)
Sponsored by
Spaulding Rehabilitation Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Pain focused on measuring Transcranial Direct Current Stimulation

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

STUDY ELIGIBILITY CRITERIA:

  1. Providing informed consent to participate in the study
  2. 18 to 64 years old

  3. Any size closed wound from burn injury, occurring at least 3 weeks prior to enrollment in the study.

    - Subjects with burns in scalp area will be excluded from the study as the electrode may cause irritation to the injuries

  4. Use of regular medications for pain and/or itching control at stable doses for at least 3 weeks prior to enrollment in the study

  5. No contraindications to tDCS:

    • metallic implants in the head
    • implanted brain medical devices
  6. Subject is not pregnant at the time of enrollment
  7. Neuropathic pain or itching (rated at least 4 on the VAS) within the burn scar or donor site, (pain can be described as burning, stabbing, piercing, pins and needles, tearing sensation) for at least 3 weeks.

Please note: If a patient reports pain and itching, we will enroll the patient based upon their most dominant symptom.

Sites / Locations

  • Spaulding Rehabilitation Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Active tDCS

Sham tDCS

Arm Description

Subjects will undergo 20 minutes of active tDCS stimulation.

Subjects will undergo sham tDCS stimulation, where the current is only active for 30 seconds.

Outcomes

Primary Outcome Measures

Effect of tDCS on pain/itch perception
Determine whether active tDCS offers a greater benefit on pain reduction in patients with neuropathic symptoms (itch/pain) following burns as compared with sham tDCS. We hypothesize that active tDCS will be associated with a larger pain/itch reduction, as indexed by the Visual Analogue Scale for Pain/Itch (VAS). The subject's VAS score will be measured immediately before the tDCS stimulation sessions and after the tDCS stimulation sessions for the duration of their participation in the trial.

Secondary Outcome Measures

Effect of tDCS on motor cortex excitability
To investigate whether active tDCS induces changes in motor cortex and spinal cord excitability as indexed by single and paired-pulse transcranial magnetic stimulation (TMS) as compared with sham tDCS. We will also determine whether these changes are correlated with the clinical outcome (pain/itch reduction). The subject's cortical excitability will be measured immediately before the tDCS stimulation sessions and after the tDCS stimulation sessions for the duration of their participation in the trial.

Full Information

First Posted
June 29, 2011
Last Updated
April 23, 2020
Sponsor
Spaulding Rehabilitation Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01404026
Brief Title
Effects of Transcranial Direct Current Stimulation (tDCS) on Neuropathic Symptoms Due to Burn Injury
Official Title
Cortical Modulation With Transcranial Direct Current Stimulation (tDCS) for Neuropathic Symptoms Following Burn Injury.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Spaulding Rehabilitation Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to investigate the effects of transcranial direct current stimulation (tDCS) on the neuropathic symptoms (pain/itch) due to a burn injury. The investigators hypothesize that the active tDCS group will show a significant pain/itch reduction when compared to sham stimulation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Burn Injury
Keywords
Transcranial Direct Current Stimulation

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active tDCS
Arm Type
Active Comparator
Arm Description
Subjects will undergo 20 minutes of active tDCS stimulation.
Arm Title
Sham tDCS
Arm Type
Sham Comparator
Arm Description
Subjects will undergo sham tDCS stimulation, where the current is only active for 30 seconds.
Intervention Type
Device
Intervention Name(s)
Transcranial Direct Current Stimulation (tDCS)
Other Intervention Name(s)
low intensity 1x1 direct current stimulator
Intervention Description
Subjects will undergo tDCS stimulation. For both active and sham stimulation we will use electrodes at 35cm^2, with an intensity of 2mA. The anodal electrode will be placed over the primary motor cortex, and the cathode will be placed over the contralateral supraorbital area. For active stimulation, the current will be active for the duration of 20 minutes. For sham stimulation, the current will only be active for 30 seconds, simulating the sensations of active stimulation.
Primary Outcome Measure Information:
Title
Effect of tDCS on pain/itch perception
Description
Determine whether active tDCS offers a greater benefit on pain reduction in patients with neuropathic symptoms (itch/pain) following burns as compared with sham tDCS. We hypothesize that active tDCS will be associated with a larger pain/itch reduction, as indexed by the Visual Analogue Scale for Pain/Itch (VAS). The subject's VAS score will be measured immediately before the tDCS stimulation sessions and after the tDCS stimulation sessions for the duration of their participation in the trial.
Time Frame
Measured for approximately 2 weeks
Secondary Outcome Measure Information:
Title
Effect of tDCS on motor cortex excitability
Description
To investigate whether active tDCS induces changes in motor cortex and spinal cord excitability as indexed by single and paired-pulse transcranial magnetic stimulation (TMS) as compared with sham tDCS. We will also determine whether these changes are correlated with the clinical outcome (pain/itch reduction). The subject's cortical excitability will be measured immediately before the tDCS stimulation sessions and after the tDCS stimulation sessions for the duration of their participation in the trial.
Time Frame
Measured for approximately 2 weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
STUDY ELIGIBILITY CRITERIA: Providing informed consent to participate in the study 18 to 64 years old Any size closed wound from burn injury, occurring at least 3 weeks prior to enrollment in the study. - Subjects with burns in scalp area will be excluded from the study as the electrode may cause irritation to the injuries Use of regular medications for pain and/or itching control at stable doses for at least 3 weeks prior to enrollment in the study No contraindications to tDCS: metallic implants in the head implanted brain medical devices Subject is not pregnant at the time of enrollment Neuropathic pain or itching (rated at least 4 on the VAS) within the burn scar or donor site, (pain can be described as burning, stabbing, piercing, pins and needles, tearing sensation) for at least 3 weeks. Please note: If a patient reports pain and itching, we will enroll the patient based upon their most dominant symptom.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Felipe Fregni, MD, PhD, MPH
Organizational Affiliation
Spaulding Rehabilitation Hospital (SRH)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Spaulding Rehabilitation Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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