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

Pain Clinical Trial

Official title:

Cortical Modulation With Transcranial Direct Current Stimulation (tDCS) for Neuropathic Symptoms Following Burn Injury.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01404026
• Other study ID #: 2010-p-001209
• Status: Completed
• Phase: N/A
• Start date: June 2011
• Est. completion date: January 2012

Study information

• Verified date: April 2020
• Source: Spaulding Rehabilitation Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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.

Related Conditions & MeSH terms

• Burn Injury
• Burns
• Pain
• Wounds and Injuries

Intervention

Device:
• Transcranial Direct Current Stimulation (tDCS)
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.

Locations

Country	Name	City	State
United States	Spaulding Rehabilitation Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Spaulding Rehabilitation Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Measured for approximately 2 weeks
Secondary	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.	Measured for approximately 2 weeks.