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

Chronic Pain Clinical Trial

Official title:

Boston-Harvard Burn Injury Model System: Cortical Modulation With Transcranial Direct Current Stimulation (tDCS) for Neuropathic Symptoms Following Burn Injury

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01795079
• Other study ID #: 2012-p-001996
• Status: Completed
• Phase: N/A
• Start date: January 2013
• Est. completion date: April 15, 2020

Study information

• Verified date: February 2021
• Source: Spaulding Rehabilitation Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: April 15, 2020
• Est. primary completion date: July 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Burn Injury
• Burns
• Chronic Pain
• Itching
• Pruritus
• Wounds and Injuries

Intervention

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.

Locations

Country	Name	City	State
United States	Spaulding Rehabilitation Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Spaulding Rehabilitation Hospital	U.S. Department of Education

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Quality of Life Scale	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). There are eight domains total including: bodily pain, role limitations due to physical problems, physical functioning, general health perception, vitality, social functioning, and role limitations due to mental health issues. Scores for each domain are from 0-100 with a higher score defining a more favorable health outcome.	2 weeks
Other	Change in Community Integration Scale	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). Total CIQ scores were used as the outcome measure. Contains 15 itms assessing community integrations across three domains (Home integration, social integration, productive activity) . The total score can range from 0 to 29 points (0 - minimal integration to 29 -maximal integration). A positive change indicates an improvement in integration.	2 weeks
Primary	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
Primary	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	Change in Depression Scale	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). The Beck Depression Inventory (BDI) contains 21 questions, each answer being scored on a scale value of 0 to 3 (total from 0-63). Higher total scores indicate more severe depressive symptoms.	2 weeks
Secondary	Change in Post-Traumatic Stress Symptoms Scale	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).This 22-item scale is designed to measure severity of PTS symptoms associated with a traumatic event. Subjects rate their level of distress associated with the event on a 0-4 scale (0 means not at all distressed, 4 means extremely distressed). The IES-R yields a total score (ranging from 0 to 88) where higher scores represent higher stress	2 weeks
Secondary	Change in Anxiety Scale	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).This is a self-evaluation scale that ranges from 0 to 10, where 0 means no anxiety and 10 means the worst anxiety ever.	2 weeks

External Links

•   Boston-Harvard Burn Injury Model System Website