Effects of Bodily Illusion and tDCS on SCI-related Neuropathic Pain

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effect of a combination of two procedures: (1) Bodily Illusion (BI) and (2) Transcranial direct electrical stimulation (tDCS) on neuropathic pain.

Official Title
-----------------
Effects of Bodily Illusion and tDCS on Spinal Cord Injury (SCI) Related Neuropathic Pain

Conditions
-----------------
Neuropathic Pain

Intervention / Treatment
-----------------
* Other: Bodily Illusions (BI) Procedure
* Device: Transcranial direct electrical stimulation (tDCS)
* Other: Sham Transcranial Direct Electrical Stimulation (tDCS)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants will be men or women, 18-70 years of age, with an incomplete cervical traumatic SCI. Participants must have experienced neuropathic pain for a minimum of six months. They must have neuropathic pain in the moderate to severe category, which will be defined as a score of at least 4 on a Numeric Rating Scale (NRS); (range of 0 to 10). Participants must be willing and able to sign informed consent Exclusion Criteria: Major psychiatric disease/disorder (self-reported) A significant neurological trauma besides SCI A recent (one-year) history of alcohol or drug abuse (selfreported) Any other medical conditions in which transcranial DCS is relatively contraindicated, such as pregnancy, epilepsy and/or seizures

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BI-TDCS Stimulation Group<br>Participants in this group will receive the BI and TDCS interventions for 10 sessions over two weeks. | Other: Bodily Illusions (BI) Procedure<br>* Each sessions will consists of two types of illusions that are 15 min each, the rubber hand illusion (RHI) and the walking illusion (WI) that involve both arms and legs.<br>Device: Transcranial direct electrical stimulation (tDCS)<br>* Each sessions will consists of electrical current delivered from a battery-driven, constant current stimulator using saline-soaked surface sponge electrodes. One electrode will be placed on your scalp on the right side and the other electrode over the left eye on your forehead. A weak current will be applied for 30 min at the same time as the BI.<br>|
| Sham Comparator: BI-TDCS (Sham) Stimulation Group<br>Participants in this group will receive the BI and TDCS (Sham) interventions for 10 sessions over two weeks. | Other: Bodily Illusions (BI) Procedure<br>* Each sessions will consists of two types of illusions that are 15 min each, the rubber hand illusion (RHI) and the walking illusion (WI) that involve both arms and legs.<br>Other: Sham Transcranial Direct Electrical Stimulation (tDCS)<br>* Each session of the Sham tDCS will be applied for 30 min at the same time as the BI.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in neuropathic pain severity | Assessed by the use of the Neuropathic Pain Symptom Inventory (NPSI). The NPSI has a total score ranging from 0 to 100 with the higher score indicating greater pain. | baseline, up to two weeks | 
| Change in performance of body part processing | Assessed by a customized computer task, where individual reaction times will be measured in response to mental rotation of body parts. Results will be reported in milliseconds. | baseline, up to two weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in sensory thresholds | Assessed by the Quantitative Sensory Testing. Pain thresholds will be assessed using a numeric rating of 0 (No pain) to 10 (worse pain imaginable). | baseline, up to two weeks |