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

NCT01795079 | Completed Results DMC

• 1 other identifier: 2012-p-001996
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Burn Injury; Chronic Pain; Pruritus; Itching

Keywords

transcranial stimulation; direct current

Outcome Measures

Primary Outcomes (2)

• Change in Pain Scale

  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 weeks

• Change in Itch Severity/Activity Scale

  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.

  2 weeks

Secondary Outcomes (3)

• Change in Depression Scale

  2 weeks

• Change in Post-Traumatic Stress Symptoms Scale

  2 weeks

• Change in Anxiety Scale

  2 weeks

Other Outcomes (2)

• Change in Quality of Life Scale

  2 weeks

• Change in Community Integration Scale

  2 weeks

Study Arms (2)

Active tDCS

EXPERIMENTAL

Subjects will undergo 20 minutes active tDCS.

Device: Transcranial direct current stimulation (tDCS)

Sham tDCS

SHAM COMPARATOR

Subjects will undergo 20 minutes of sham stimulation.

Device: Transcranial direct current stimulation (tDCS)

Interventions

Transcranial direct current stimulation (tDCS) DEVICE

Subjects will undergo 15 sessions of tDCS stimulation (either active or sham), 1x per day at 20 minutes per session.

Also known as: 1x1 low-intensity direct current stimulator, Soterix Medical

Active tDCS; Sham tDCS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Spaulding Rehabilitation Hospital: lead
• U.S. Department of Education: collaborator

Study Sites (1)

Spaulding Rehabilitation Hospital

Boston, Massachusetts, 02129, United States

Location

Related Links

• Boston-Harvard Burn Injury Model System Website

MeSH Terms

Conditions

Burns; Chronic Pain; Pruritus

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Wounds and Injuries; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Results Point of Contact

• Title: Felipe Fregni
• Organization: Spaulding Rehabilitation Hospital

fregni.felipe@mhg.harvard.edu

6179526158

Study Officials

• Felipe Fregni, MD PhD MPH

  Spaulding Rehabilitation Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 15, 2013
• First Posted: February 20, 2013
• Study Start: January 1, 2013
• Primary Completion: July 1, 2019
• Study Completion: April 15, 2020
• Last Updated: March 17, 2021
• Results First Posted: March 17, 2021

Record last verified: 2021-02

Locations

US (1)