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Non-invasive Brain Stimulation

Sensorimotor Training + RTMS for Complex Regional Pain Syndrome

N/A
Recruiting
Research Sponsored by McMaster University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
A diagnosis of CRPS type 1 affecting one of their hands
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 week before intervention, immediately before intervention, immediately following intervention, 6 months after intervention
Awards & highlights

Study Summary

This trial will investigate whether combining a non-invasive brain stimulation technique with a sensorimotor training task can reduce pain symptoms in patients with complex regional pain syndrome.

Who is the study for?
This trial is for individuals with Complex Regional Pain Syndrome (CRPS) type 1 in one hand. Participants should not have moderate to severe chronic pain elsewhere, daily opioid use before CRPS diagnosis, contraindications to magnetic stimulation, or psychological issues affecting understanding.Check my eligibility
What is being tested?
The study tests if repetitive transcranial magnetic stimulation (rTMS), a non-invasive brain stimulation technique, combined with sensorimotor training can reduce pain in CRPS patients. It checks the feasibility of recruiting and maintaining patient adherence to this treatment.See study design
What are the potential side effects?
Potential side effects may include discomfort at the stimulation site, headache, lightheadedness or seizures from rTMS; and muscle fatigue or soreness from sensorimotor training. Individual experiences may vary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have been diagnosed with CRPS type 1 in one of your hands.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 week before intervention, immediately before intervention, immediately following intervention, 6 months after intervention
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 week before intervention, immediately before intervention, immediately following intervention, 6 months after intervention for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Ability to recruit 6 patients in each group over a 6-month period
Compliance of treatment sessions as proposed
Secondary outcome measures
Assessments of swelling and skin discolouration using pictures and videos
Brain derived neurotrophic factor (BDNF)
Complex Regional Pain Syndrome Severity Scale
+13 more

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Group C-Sensorimotor trainingExperimental Treatment1 Intervention
Participants will perform sensorimotor training intervention. Nerve stimulation will be applied to the second through fifth digits and the wrist of the affected limb to cue movement. This intervention will be performed approximately 4 days per week for 4 weeks. In addition, participants will experience their standard medical care.
Group II: Group B-rTMS and sensorimotor trainingExperimental Treatment2 Interventions
Repetitive transcranial magnetic stimulation (rTMS) will be delivered at 10 Hz, 2000 pulses targeting the hand representation of the left primary motor cortex. Immediately following rTMS, participants will perform sensorimotor training. Nerve stimulation will be applied to the second through fifth digits and the wrist of the affected limb to cue movement. This intervention will be performed approximately 4 days per week for 4 weeks. In addition, participants will experience their standard medical care.
Group III: Group A-ControlActive Control1 Intervention
Participants in this arm will not experience any intervention during a 4 week period of time. Participants will experience their standard medical care.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Repetitive transcranial magnetic stimulation
2008
Completed Phase 3
~920

Find a Location

Who is running the clinical trial?

McMaster UniversityLead Sponsor
876 Previous Clinical Trials
2,595,982 Total Patients Enrolled
St. Joseph's Healthcare HamiltonOTHER
195 Previous Clinical Trials
25,406 Total Patients Enrolled

Media Library

Repetitive transcranial magnetic stimulation (Non-invasive Brain Stimulation) Clinical Trial Eligibility Overview. Trial Name: NCT05197959 — N/A
Complex Regional Pain Syndrome Research Study Groups: Group C-Sensorimotor training, Group B-rTMS and sensorimotor training, Group A-Control
Complex Regional Pain Syndrome Clinical Trial 2023: Repetitive transcranial magnetic stimulation Highlights & Side Effects. Trial Name: NCT05197959 — N/A
Repetitive transcranial magnetic stimulation (Non-invasive Brain Stimulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05197959 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What specific goals is this research endeavor trying to accomplish?

"This trial's primary purpose is to evaluate the efficacy of a 4-week intervention over a 6-month period by recruiting 6 participants into each group. Other secondary outcomes that will be assessed include Von Frey Filament (measuring mechanical sensitivity on hand using decreasing diameter monofilaments until application cannot be felt), Rainbow Pain Scale (sensory assessments of affected limb with increasing force and size von Frey filaments until painful response is elicited) and Medication Use (quantity of daily narcotic or non-narcotic drugs)."

Answered by AI

May I volunteer to participate in this scientific experiment?

"This study is looking for 18 individuals within the ages of legal adulthood and 70 years old who have been diagnosed with Complex Regional Pain Syndrome (RSD). Additionally, they must be dealing with CRPS Type 1 in one hand."

Answered by AI

Are there any vacancies still available for this investigation?

"Contrary to clinicaltrials.gov's listing, this particular trial is no longer seeking patients - the posting was first published in May of 2022 and last edited at the end of March that same year. Despite this fact, there are over 1400 other medical studies accepting volunteers for enrollment presently."

Answered by AI

Is the age limit for this trial restricted to individuals under 55 years old?

"The minimum age for enrolment into this clinical trial is 18 years old and the maximum permissible age is 70."

Answered by AI
~8 spots leftby Mar 2025