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

Mount Sinai Health System

Status: Withdrawn

Conditions: Spinal Cord Injuries; Chronic Pain; Neuralgia

Treatments: Device: Transcranial Magnetic Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT05226676

19-1382-00001-01-PD (Other Grant/Funding Number)

STUDY-20-00230

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria:

• 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.

Exclusion criteria:

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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0 participants in 2 patient groups

Real rTMS group

Experimental group

Description:

Repetitive TMS at 20Hz frequency over the M1 will be performed for five consecutive days for 2 weeks (using 90% of the resting motor threshold/total of 500 pulses). The rTMS will be applied through a figure-8 coil connected to a magnetic stimulator, which provides a biphasic pulse. This protocol was developed in accordance with the guidelines for the safe use of rTMS.

Treatment:

Device: Transcranial Magnetic Stimulation

Sham group

Sham Comparator group

Description:

Sham stimulation will be performed for five consecutive days for 2 weeks (using 90% of the resting motor threshold/total of 500 pulses). For the sham stimulation a sham coil will be used.

Treatment:

Device: Transcranial Magnetic Stimulation