Clinical trial NCT05226676: Long-term Effects of Repetitive TMS in Chronic Neuropathic Pain in People With SCI
Official title: Long-term Effects of Repetitive TMS in Chronic Neuropathic Pain in People With SCI
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Spinal Cord Injuries
Neuralgia
Chronic Pain
Keywords: Spinal Cord Injuries
Neuropathic
Chronic Pain
Transcranial Magnetic Stimulation
Neural Plasticity
Pain
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2022-02-07
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized double blinded sham controlled study
Primary purpose: TREATMENT

Brief 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.


Eligibility 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:

Primary outcomes:
measure: Neuropathic Pain Scale (NPS)
timeFrame: 6 weeks
Secondary outcomes:
measure: Numeric Rating Scale (NRS)
timeFrame: 6 weeks
measure: Short-Form McGill Pain Questionnaire. (SF-MPQ)
timeFrame: 6 weeks
measure: Present Pain Intensity (PPI) index
timeFrame: 6 weeks
measure: Visual Analogue Scale (VAS)
timeFrame: 6 weeks
measure: The American Spinal Injury Association Impairment Scale (ASIA scale)
timeFrame: 6 weeks
measure: Spinal cord independence measure (SCIM III)
timeFrame: 6 weeks
measure: Modified Ashworth Scale (MAS)
timeFrame: 6 weeks
measure: Beck Depression Inventory (BDI)
timeFrame: 6 weeks
measure: Patient's Global Impression of Change (PGIC)
timeFrame: 6 weeks
measure: Resting Motor Threshold (RMT)
timeFrame: 6 weeks
measure: Recruitment curve (RC)
timeFrame: 6 weeks
measure: Short intracortical inhibition (SICI)
timeFrame: 6 weeks
measure: Silent period (SP):
timeFrame: 6 weeks
measure: Sensory threshold (ST):
timeFrame: 6 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: Abilities Research Center
state: New York
Study officials:
affiliation: Icahn School of Medicine
name: Mar Cortes, M.D.
role: PRINCIPAL_INVESTIGATOR
References: