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

University of Miami8 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

SINGLE

Enrollment

Conditions

Neuropathic Pain

Interventions

Bodily Illusions (BI) ProcedureOTHER

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.

Transcranial direct electrical stimulation (tDCS)DEVICE

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.

Sham Transcranial Direct Electrical Stimulation (tDCS)OTHER

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Participants will be men or women, 18-70 years of age, with an incomplete cervical traumatic SCI. 2. 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). 3. Participants must be willing and able to sign informed consent Exclusion Criteria: 1. Major psychiatric disease/disorder (self-reported) 2. A significant neurological trauma besides SCI 3. A recent (one-year) history of alcohol or drug abuse (selfreported) 4. Any other medical conditions in which transcranial DCS is relatively contraindicated, such as pregnancy, epilepsy and/or seizures

Locations (1)

University of Miami

Miami, Florida, United States

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: baseline, up to two weeks

Secondary Outcomes

Change in Sensory Thresholds

Assessed by the Quantitative Sensory Testing. Pain thresholds are evaluated using Medoc machine (Medoc Ltd,Ramat Yishai, Israel and FDA approved. It assesses participants' ability to feel change in temperature (0°C to 50°C). The temperatures in this range may be felt as cool, cold, warm, and hot. A probe is placed on the skin and it feels either cool, cold, warm or hot. Participants' thresholds are recorded for cool or warm sensation, and for cold or hot painful thresholds.

Time frame: baseline, up to two weeks

Data from ClinicalTrials.gov

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