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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
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
No Placebo-Only Group
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.
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.
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 week before intervention, immediately before intervention, immediately following intervention, 6 months after intervention
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 week before intervention, immediately before intervention, immediately following intervention, 6 months after intervention
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Ability to recruit 6 patients in each group over a 6-month period
Compliance of treatment sessions as proposed
Secondary study objectives
Assessments of swelling and skin discolouration using pictures and videos
Brain derived neurotrophic factor (BDNF)
Complex Regional Pain Syndrome Severity Scale
+13 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
~1000
Find a Location
Who is running the clinical trial?
McMaster UniversityLead Sponsor
916 Previous Clinical Trials
2,615,210 Total Patients Enrolled
St. Joseph's Healthcare HamiltonOTHER
201 Previous Clinical Trials
26,935 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a history of moderate to severe chronic pain in other parts of your body.You were taking opioids every day before being diagnosed with CRPS.You have conditions that make it unsafe for you to receive transcranial magnetic stimulation.You have a known mental health condition that affects your understanding.You have been diagnosed with CRPS type 1 in one of your hands.
Research Study Groups:
This trial has the following groups:- Group 1: Group B-rTMS and sensorimotor training
- Group 2: Group C-Sensorimotor training
- Group 3: Group A-Control
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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