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Behavioural Intervention

rTMS + Rehabilitation for Complex Regional Pain Syndrome

N/A
Recruiting
Led By Adam Rufa, DPT, PhD
Research Sponsored by State University of New York - Upstate Medical University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up sessions 1 (week 1), 4 (week 1), 6 (week 2), 8 (week 3), 10 (week 4). surveys will also be sent at 4 weeks, 3 months, 6 months, and 1 year after last session.

Summary

This trial will test if rTMS and rehab can reduce pain from CRPS Type 1. Subjects get 4 rTMS treatments and 2 rehab treatments in 1st wk, then 2 rTMS and 2 rehab treatments in following wks. Outcome measured by pain ratings, PROMIS, GROC, grip strength/leg press.

Who is the study for?
This trial is for individuals with CRPS Type 1, a pain condition affecting limbs, who've had it for at least 6 months. They must have stable treatment plans and moderate pain levels. It's not suitable for those with mental disorders preventing consent, non-English speakers, seizure history, metallic brain devices, pacemakers, or pregnant women.
What is being tested?
The study tests if repeated transcranial magnetic stimulation (rTMS) combined with rehabilitation can reduce pain in CRPS Type 1 patients. Participants are randomly assigned to real rTMS or sham (fake) rTMS plus rehab over four weeks to compare the effects on pain and physical function.
What are the potential side effects?
Possible side effects of rTMS include discomfort at the stimulation site, headache, lightheadedness or seizures in very rare cases. Rehabilitation may cause muscle soreness or fatigue.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~sessions 1 (week 1), 4 (week 1), 6 (week 2), 8 (week 3), 10 (week 4). surveys will also be sent at 4 weeks, 3 months, 6 months, and 1 year after last session
This trial's timeline: 3 weeks for screening, Varies for treatment, and sessions 1 (week 1), 4 (week 1), 6 (week 2), 8 (week 3), 10 (week 4). surveys will also be sent at 4 weeks, 3 months, 6 months, and 1 year after last session for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Numeric Pain Rating Scale (NPRS) Weekly Average
Secondary study objectives
Global Rating of Change (GROC)
Global Rating of Change Impact (GROCi)
Grip Strength or 1 Rep Leg Press
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: rTMS and RehabilitationExperimental Treatment2 Interventions
Subjects in this arm will get rTMS to the contralateral motor cortex and best practice rehabilitation.
Group II: Sham rTMS and RehabilitationPlacebo Group2 Interventions
Subjects in this arm will get sham rTMS to the contralateral motor cortex and best practice rehabilitation.

Find a Location

Who is running the clinical trial?

State University of New York - Upstate Medical UniversityLead Sponsor
174 Previous Clinical Trials
27,450 Total Patients Enrolled
Reflex Sympathetic Dystrophy Syndrome Association (RSDSA)UNKNOWN
Adam Rufa, DPT, PhDPrincipal InvestigatorSUNY Upstate Medical Univerity

Media Library

Repeated Transcranial Magnetic Stimulation (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05745025 — N/A
Complex Regional Pain Syndrome Research Study Groups: rTMS and Rehabilitation, Sham rTMS and Rehabilitation
Complex Regional Pain Syndrome Clinical Trial 2023: Repeated Transcranial Magnetic Stimulation Highlights & Side Effects. Trial Name: NCT05745025 — N/A
Repeated Transcranial Magnetic Stimulation (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05745025 — N/A
~1 spots leftby Feb 2025
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