Brain Stimulation for Complex Regional Pain Syndrome

Overseen By Stevie Foglia, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: McMaster University

Disqualifiers: Chronic CRPS, TMS contraindications, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: Approximately 15 minutes

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to help people with complex regional pain syndrome (CRPS) manage their pain. It uses repetitive transcranial magnetic stimulation (rTMS), which involves magnetic pulses to activate specific brain areas. Researchers aim to customize this treatment to each person's brain activity for greater effectiveness. The trial seeks participants who have experienced CRPS in their arms or legs for at least three months but less than three years. As an unphased trial, it offers a unique opportunity to contribute to innovative research that could lead to personalized pain management solutions.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team for guidance.

What prior data suggests that this technique is safe for treating complex regional pain syndrome?

Research has shown that repetitive transcranial magnetic stimulation (rTMS) is generally well-tolerated. This technique uses magnetic pulses to stimulate the brain non-invasively, aiming to reduce pain. Studies have found significant pain reduction following rTMS sessions. For instance, one study noted much lower pain levels a week after treatment. Another study reported immediate pain relief after treatment, with continued improvement a week later.

Regarding safety, many studies have used rTMS without any serious side effects. This evidence suggests that rTMS is both effective in reducing pain and safe for participants. However, individual responses may vary, so potential participants should discuss any concerns with the trial team. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Repetitive transcranial magnetic stimulation (rTMS) is unique because it uses magnetic fields to stimulate nerve cells in the brain, offering a non-invasive alternative for managing Complex Regional Pain Syndrome (CRPS). Unlike the standard treatments, which often rely on medications like pain relievers and nerve blocks, rTMS directly targets brain activity associated with pain perception. Researchers are excited about rTMS because it has the potential to provide pain relief without the side effects commonly associated with drugs, offering a new avenue for patients who have not found relief with existing therapies.

What evidence suggests that repetitive transcranial magnetic stimulation is effective for complex regional pain syndrome?

Research has shown that repetitive transcranial magnetic stimulation (rTMS) might help reduce pain in people with complex regional pain syndrome (CRPS). Studies have found that rTMS, when applied to a specific part of the brain called M1, can lower pain levels by 20% to 50%. In some cases, long-term follow-ups reported up to 90% relief from symptoms, including pain, and an improved quality of life. rTMS has also helped patients with CRPS who did not respond well to other treatments. Overall, early evidence suggests that rTMS could be a promising option for managing CRPS pain. Participants in this trial will receive rTMS brain stimulation as part of the BCI training and testing group. ^{6 7 8 9 10}

Who Is on the Research Team?

Aimee J Nelson, PhD

Principal Investigator

McMaster University

Are You a Good Fit for This Trial?

This trial is for individuals with Complex Regional Pain Syndrome (CRPS) who are interested in a non-drug treatment. Participants should be willing to undergo brain stimulation and have their brain activity measured. Specific eligibility details are not provided, but typically include age, health status, and CRPS severity.

Inclusion Criteria

I have been diagnosed with CRPS Type 1 in my arm or leg.

I have had CRPS for at least 3 months.

Exclusion Criteria

Prior experience with TMS

I was diagnosed with CRPS over 3 years ago.

I am unable to take part in the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

BCI Training

Participants undergo BCI training with 30 trials of the investigator's task

Approximately 45 minutes

1 visit (in-person)

Treatment

Real-time MRCP tailored rTMS intervention is administered

Approximately 15 minutes

1 visit (in-person)

Follow-up

Participants are monitored for changes in pain ratings and neurophysiological markers

Immediately after intervention

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Repetitive transcranial magnetic stimulation

Trial Overview The study tests repetitive transcranial magnetic stimulation (rTMS), a noninvasive procedure that stimulates the brain to reduce pain in CRPS patients. It will explore if rTMS can be personalized using EEG measurements and whether timing with EEG activity enhances its effectiveness.

How Is the Trial Designed?

Group I: BCI training and testing group Experimental Treatment 1 Intervention

This group will contain all participants. All participants will receive the same rTMS brain stimulation, a series of 90 triplet pulses at 100 Hz.

Who Is Running the Clinical Trial?

McMaster University

Lead Sponsor

Trials

936

Recruited

2,630,000+

Michael G. DeGroote Institute for Pain Research and Care (IPRC)

Collaborator

Trials

1

Recruited

100+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11760760/

Repetitive Transcranial Magnetic Stimulation for the Treatment ... For CRPS, data is limited, but initial studies demonstrate that rTMS delivered over M1 is effective at reducing pain by 20–50%. One study ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S305052912500087X

Use of deep repetitive transcranial magnetic (dTMS ... Long-term follow-up assessment (at 140 days) revealed 90 % alleviation of most of her symptoms including pain. It also resulted in better quality of her life.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT07208825

The Effectiveness of Conservative Treatment in Patients ... The aim of the study is to investigate and improve non-pharmacological rehabilitation methods for patients with Complex Regional Pain ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/20430702/

Repetitive transcranial magnetic stimulation is efficacious ... This study shows an efficacy of repetitive sessions of high-frequency rTMS as an add-on therapy to refractory CRPS type I patients.

5. journals.lww.com journals.lww.com/aacr/fulltext/2024/04000/repetitive_transcranial_magnetic_stimulation_with.1.aspx

Repetitive Transcranial Magnetic Stimulation with... Previous reports in CRPS have shown a 31% decrease in pain catastrophizing after graded motor imagery and transcranial direct current stimualtion. 14 rTMS has ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7711855/

The effect of rTMS in the management of pain associated with ... However, pain significantly reduced 1 week after the entire schedule of rTMS sessions (P < 0.001). Conclusion. rTMS appears to have a functional analgesic ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05197959

Treatment of Complex Regional Pain Syndrome This study will investigate the feasibility of using repetitive transcranial magnetic stimulation (rTMS) and a sensorimotor training task to treat symptoms ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1094715921022406

Advancing Transcranial Magnetic Stimulation Methods for ... Both groups demonstrated significant pain reduction after one session and one-week posttreatment; however, no group differences were present. From a single ...

9. e-hpr.org e-hpr.org/journal/view.php?number=917

Efficacy and Safety of Repetitive Transcranial Magnetic ... Meta-analysis showed significant pain reduction with rTMS compared to sham treatment. At 2 weeks post-treatment, the mean pain score difference ...

10. brainstimjrnl.com brainstimjrnl.com/article/S1935-861X(21)00166-2/fulltext

Utilizing Repetitive Transcranial Magnetic Stimulation (rTMS ... Results: At one month, the patient reported a 30% reduction in total pain and increased overall quality of life, functional mobility, and independence. Average ...