MedTrace Logo

Long-term Effects of Repetitive TMS in Chronic Neuropathic Pain in People With SCI

NCT05226676 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2023-08-04

No results posted yet for this study

Summary

Around 80% of people with spinal cord injury (SCI) develop chronic neuropathic pain (CNP). This is a debilitating condition with major negative impacts on people's quality of life. Many treatment options have been offered (invasive stimulation, drugs) but provide limited effects and many secondary effects. There is a critical need to develop a new generation of therapies. Transcranial magnetic stimulation (TMS) is a non-invasive and painless brain stimulation technique that allows researchers to explore and change brain excitability that has shown promising effects in neuropathic pain. However there is not enough evidence of what are the long lasting effects of the different protocols. In this study, 30 SCI subjects with CNP in their hands will participate in the study. The objective is to evaluate the efficacy of real versus sham repetitive transcranial magnetic stimulation (rTMS) and investigate 1) short and long term effects on pain and 2) the behavioral and neurophysiological qualities of responders and non-responders to this treatment.This will be a randomized sham controlled trial with two groups: real or sham high frequency repetitive TMS protocol (20Hz). The protocol will be done daily for two weeks. Clinical, functional and neurophysiological evaluations will be assessed at baseline, post intervention and at 6-week follow up.

Conditions

Interventions

DEVICE

Transcranial Magnetic Stimulation

Transcranial magnetic stimulation (TMS) is a non-invasive and painless brain stimulation technique that allows the brain excitability to change based on Faraday's Law of Electromagnetic induction . Since the presentation of the CNP is usually bilateral, the coil will be targeting the dominant hand abductor pollicis brevis (APB) muscle. If the pain is more intense in one of the arms, that arm will be targeted. This protocol was developed in accordance with the guidelines for the safe use of rTMS.

Sponsors & Collaborators

Principal Investigators

  • Mar Cortes, M.D. · Icahn School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-31
Primary Completion
2023-12-31
Completion
2023-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05226676 on ClinicalTrials.gov