N/A
N=31
Effects of Transcranial Direct Current Stimulation (tDCS) on Neuropathic Symptoms Following Burn Injury
Burn Injury · Chronic Pain · Pruritus · Itching
Bottom Line
View on ClinicalTrials.gov: NCT01795079 ↗Enrolled (actual)
31
Serious AEs
0.0%
Results posted
Mar 2021
Primary outcome: Primary: Change in Pain Scale — 4.45; 4.19 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Transcranial direct current stimulation (tDCS) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Spaulding Rehabilitation Hospital
- Primary completion
- Jul 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Pain Scale |
4.45; 4.19 | — |
| PRIMARY Change in Itch Severity/Activity Scale |
3.65; 1.83 | — |
| SECONDARY Change in Depression Scale |
9.1; 9.2 | — |
| SECONDARY Change in Post-Traumatic Stress Symptoms Scale |
10.8; 36.3 | — |
| SECONDARY Change in Anxiety Scale |
3.25; 2.92 | — |
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.
Eligibility 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)
Data sourced from ClinicalTrials.gov (NCT01795079). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.