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

Not Applicable

Completed

• Conditions: Neuropathic Pain
• Interventions: Other: Bodily Illusions (BI) Procedure; Device: Transcranial direct electrical stimulation (tDCS); Other: Sham Transcranial Direct Electrical Stimulation (tDCS)

• Registration Number: NCT04578574
• Lead Sponsor: University of Miami

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-10-02
• Study First Submitted QC: 2020-10-02
• Study First Posted: 2020-10-08
• Study Start: 2021-01-13
• Primary Completion: 2023-03-10
• Study Completion: 2023-03-10
• Results First Submitted: 2024-01-22
• Status Verified: 2024-02
• Results First Submitted QC: 2024-02-21
• Last Update Submitted: 2024-02-21
• Results First Posted: 2024-03-19
• Last Update Posted: 2024-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BI-TDCS Stimulation Group	Transcranial direct electrical stimulation (tDCS)	Participants in this group will receive the BI and TDCS interventions for 10 sessions over two weeks.
BI-TDCS (Sham) Stimulation Group	Sham Transcranial Direct Electrical Stimulation (tDCS)	Participants in this group will receive the BI and TDCS (Sham) interventions for 10 sessions over two weeks.
BI-TDCS Stimulation Group	Bodily Illusions (BI) Procedure	Participants in this group will receive the BI and TDCS interventions for 10 sessions over two weeks.
BI-TDCS (Sham) Stimulation Group	Bodily Illusions (BI) Procedure	Participants in this group will receive the BI and TDCS (Sham) interventions for 10 sessions over two weeks.

Primary Outcome Measures

Name	Time	Method
Change in Neuropathic Pain Severity	baseline, up to two weeks	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.
Change in Performance of Body Part Processing	baseline, up to two weeks	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.

Secondary Outcome Measures

Name	Time	Method
Change in Sensory Thresholds	baseline, up to two weeks	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.

Trial Locations

Locations (1)

University of Miami; 🇺🇸 Miami, Florida, United States