Clinical trial NCT01795079: Effects of Transcranial Direct Current Stimulation (tDCS) on Neuropathic Symptoms Following Burn Injury
Official title: Boston-Harvard Burn Injury Model System: Cortical Modulation With Transcranial Direct Current Stimulation (tDCS) for Neuropathic Symptoms Following Burn Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Burn Injury
Chronic Pain
Pruritus
Itching
Keywords: transcranial stimulation
direct current
Lead sponsor: Spaulding Rehabilitation Hospital
Sponsor class: OTHER
Collaborators: name: U.S. Department of Education
First posted: 2013-02-20
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Change in Pain Scale
timeFrame: 2 weeks
measure: Change in Itch Severity/Activity Scale
timeFrame: 2 weeks
Secondary outcomes:
measure: Change in Depression Scale
timeFrame: 2 weeks
measure: Change in Post-Traumatic Stress Symptoms Scale
timeFrame: 2 weeks
measure: Change in Anxiety Scale
timeFrame: 2 weeks
Other outcomes:
measure: Change in Quality of Life Scale
timeFrame: 2 weeks
measure: Change in Community Integration Scale
timeFrame: 2 weeks
Locations:
city: Boston
country: United States
facility: Spaulding Rehabilitation Hospital
state: Massachusetts
Study officials:
affiliation: Spaulding Rehabilitation Hospital
name: Felipe Fregni, MD PhD MPH
role: PRINCIPAL_INVESTIGATOR
References: