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

Withdrawn before enrolling · Not applicable · Has a placebo group

Conditions studied: Spinal Cord Injuries, Neuralgia, Chronic Pain

In brief

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.

Key facts

Study ID

NCT05226676

Run by

Icahn School of Medicine at Mount Sinai

People needed

0

Starts

2023-08-01

Expected to finish

2023-12-01

Last updated by the study team

2023-08-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• presence of chronic neuropathic pain at or below SCI level for at least 6 months following trauma or disease of the spinal cord.
• cervical lesion.
• CNP in the upper extremity.
• pain intensity of at least 4 out of 10 in the numerical rating scale (NRS) in the NPS both screening (baseline) and randomization (pre-evaluation).both screening (baseline) and randomization (pre-evaluation).
• stable pharmacological treatment for at least 2 weeks prior to the study and throughout the trial.
• complete or incomplete lesion.

Where it is running

• Abilities Research Center — New York, New York, United States

Full record on ClinicalTrials.gov

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