Long-term Effects of Repetitive TMS in Chronic Neuropathic Pain in People With SCI
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Spinal Cord Injuries
- Sponsor
- Icahn School of Medicine at Mount Sinai
- Locations
- 1
- Primary Endpoint
- Neuropathic Pain Scale (NPS)
- Status
- Withdrawn
- Last Updated
- 2 years ago
Overview
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.
Investigators
Maria Del Mar Cortes
Assistant Professor
Icahn School of Medicine at Mount Sinai
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Neuropathic Pain Scale (NPS)
Time Frame: 6 weeks
This scale was developed to assess both the quantitative and qualitative qualities of NP. It includes 11 items, assessing global pain intensity, unpleasantness, and one item which allows the patient to describe the temporal aspects of their pain and its qualities in their own words. The remaining 8 items assess specific NP qualities: "Sharp," "Hot," "Dull," "Cold," "Sensitive," "Itchy," "Deep," and "Surface." This is a sensitive tool for measuring changes in neuropathic pain after a therapeutic intervention. Total scale from 0-10, with higher score indicating more pain.
Secondary Outcomes
- The American Spinal Injury Association Impairment Scale (ASIA scale)(6 weeks)
- Modified Ashworth Scale (MAS)(6 weeks)
- Numeric Rating Scale (NRS)(6 weeks)
- Short-Form McGill Pain Questionnaire. (SF-MPQ)(6 weeks)
- Present Pain Intensity (PPI) index(6 weeks)
- Visual Analogue Scale (VAS)(6 weeks)
- Spinal cord independence measure (SCIM III)(6 weeks)
- Patient's Global Impression of Change (PGIC)(6 weeks)
- Beck Depression Inventory (BDI)(6 weeks)
- Resting Motor Threshold (RMT)(6 weeks)
- Recruitment curve (RC)(6 weeks)
- Silent period (SP):(6 weeks)
- Sensory threshold (ST):(6 weeks)
- Short intracortical inhibition (SICI)(6 weeks)