IPRP + rTMS for Chronic Pain

Recruiting in Palo Alto (17 mi)

Overseen by Jillian V Miller, PhD

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Calgary

Must not be taking: Opioids

Disqualifiers: Developmental delay, Brain injury, others

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial tests whether adding brain stimulation (rTMS) to an intensive pain rehabilitation program can help youth with severe chronic pain. The treatment uses magnetic fields to stimulate specific brain areas, aiming to reduce pain and improve mental health. The study focuses on youth who haven't responded to other treatments. Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive brain stimulation technique that has been used to treat various neuropsychiatric and pain conditions, including major depressive disorder, chronic pain, and epilepsy.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does exclude those who need to wean off opioids. It's best to discuss your specific medications with the trial team.

What data supports the effectiveness of the treatment Repeated Transcranial Magnetic Stimulation (rTMS) for chronic pain?

Research suggests that repetitive transcranial magnetic stimulation (rTMS) can help relieve chronic pain, although the effects may be temporary. Some studies show that rTMS can reduce pain in conditions like neuropathic pain and fibromyalgia, and regular sessions over several weeks might lead to longer-lasting relief. ^{1 2 3 4 5}

Is rTMS safe for humans?

Repetitive transcranial magnetic stimulation (rTMS) is generally considered safe for humans, with studies showing it can provide pain relief without significant adverse effects. However, the exact parameters for safe and effective use are still being researched. ^{1 4 6 7 8}

How does the IPRP + rTMS treatment for chronic pain differ from other treatments?

The IPRP + rTMS treatment is unique because it combines a non-invasive method called repetitive transcranial magnetic stimulation (rTMS) with an interdisciplinary pain rehabilitation program (IPRP). Unlike some other treatments that may require surgery, rTMS uses magnetic fields to stimulate the brain and can provide temporary pain relief without invasive procedures. ^{1 2 3 5 9}

Research Team

Jillian V Miller, PhD

Principal Investigator

University of Calgary

Eligibility Criteria

This trial is for young people aged 10-18 with severe chronic pain that disrupts their daily life and hasn't improved with standard pain treatments. They must understand the importance of actively managing their condition to restore function, but can't join if they have significant developmental delays, brain injuries, need opioid weaning or have untreated psychiatric illnesses.

Inclusion Criteria

I and my family agree to actively manage my recovery.

My pain severely affects my daily life and stops me from doing my usual activities.

Pain treatments haven't helped me get back to my normal activities.

Exclusion Criteria

I have been diagnosed with a functional neurological disorder.

I am a young person needing help to stop using opioids.

I do not have severe medical or psychiatric conditions that would prevent rehabilitation.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intensive Pain Rehabilitation Program (IPRP)

Participants undergo a three-week intensive day-treatment intervention provided by an interdisciplinary team to help resume engagement in normal daily functioning.

3 weeks

Daily visits (in-person)

Repeated Transcranial Magnetic Stimulation (rTMS)

Participants receive image-guided brain stimulation to enhance brain changes observed with IPRP, applied for 37.5 minutes per weekday.

3 weeks

15 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of pain, functional disability, anxiety, depressive and PTSD symptoms.

4 weeks

Treatment Details

Interventions

• Repeated Transcranial Magnetic Stimulation (rTMS) (Non-invasive Brain Stimulation)

Trial Overview The study tests whether adding Repeated Transcranial Magnetic Stimulation (rTMS) to an Intensive Pain Rehabilitation Program (IPRP) helps reduce chronic pain in youth. The rTMS targets a specific brain area affected by chronic pain and is given daily for three weeks alongside IPRP.

Participant Groups

Group I: rTMS + IPRP Experimental Treatment 2 Interventions

25 youth aged 10-18 years with severe chronic pain will be invited to partake in the Intensive Pain Rehabilitation Program, where they will receive Repeated Transcranial Magnetic Stimulation as one of their treatment interventions.

Group II: IPRP Active Control 1 Intervention

Youth within this arm will not be receiving the rTMS intervention. Rather, they will only be enrolled within the IPRP.

Who Is Running the Clinical Trial?

University of Calgary

Lead Sponsor

Trials

827

Recruited

902,000+

Dr. Shweta Patel

University of Calgary

Chief Medical Officer since 2020

MD from the University of Baroda Medical College, India

Dr. Edward McCauley

University of Calgary

President and Vice-Chancellor since 2018

PhD in Ecology and Evolutionary Biology from the University of California, Santa Barbara

Findings from Research

Repetitive transcranial magnetic stimulation (rTMS) has been shown to provide significant pain relief in chronic pain conditions, particularly with high-frequency stimulation over the primary motor cortex, achieving over 30% pain reduction compared to control treatments.

Despite the promising results, most studies did not utilize repetitive rTMS sessions, indicating a need for further research to explore the long-term effects and optimal treatment protocols for various chronic pain syndromes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Repetitive transcranial magnetic stimulation in chronic pain: a review of the literature. Galhardoni, R., Correia, GS., Araujo, H., et al.[2022]

Repetitive transcranial magnetic stimulation (rTMS) of the motor cortex significantly reduced pain levels in patients with drug-resistant neurogenic pain, showing a 22.9% reduction compared to only 7.8% with sham treatment, indicating its efficacy in pain management.

The effectiveness of rTMS was influenced by the origin and site of pain, with better outcomes for facial pain and poorer results in patients with brainstem strokes, suggesting that targeting adjacent cortical areas may be more beneficial than directly stimulating the painful zone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurogenic pain relief by repetitive transcranial magnetic cortical stimulation depends on the origin and the site of pain. Lefaucheur, JP., Drouot, X., Menard-Lefaucheur, I., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Repetitive transcranial magnetic stimulation in chronic pain: a review of the literature. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Use of repetitive transcranial magnetic stimulation in pain relief. [2022]

3. France pubmed.ncbi.nlm.nih.gov

Therapeutic impact of motor cortex rTMS in patients with chronic neuropathic pain even in the absence of an analgesic response. A case report. [2018]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Repetitive transcranial magnetic stimulation for the treatment of chronic pain - a pilot study. [2017]

5. United States pubmed.ncbi.nlm.nih.gov

Facilitation of A[delta]-fiber-mediated acute pain by repetitive transcranial magnetic stimulation. [2019]

6. France pubmed.ncbi.nlm.nih.gov

A practical algorithm for using rTMS to treat patients with chronic pain. [2020]

7. England pubmed.ncbi.nlm.nih.gov

Neurogenic pain relief by repetitive transcranial magnetic cortical stimulation depends on the origin and the site of pain. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Prolonged continuous theta-burst stimulation is more analgesic than 'classical' high frequency repetitive transcranial magnetic stimulation. [2018]

9. Japan pubmed.ncbi.nlm.nih.gov

[Repetitive Transcranial Magnetic Stimulation for Intractable Pain]. [2017]