IPRP Repeated Transcranial Magnetic Stimulation (rTMS)
Active, not recruitingNot applicableNCT04561401
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Brief summary (from the registry)
Severe chronic pain is defined as pain persisting for three months or more that significantly impacts daily functioning. It is highly prevalent, occurring in 100,000 to 160,000 youth. If left unmanaged it can lead to persistent pain and mental health problems in adulthood, posing enormous costs to society ($7.2 billion CAD/year). In 2014, health professionals at the Alberta Children's Hospital (ACH) established a pediatric Intensive Pain Rehabilitation Program (IPRP) to target youth with severe chronic pain and consequent functional disability who do not respond to outpatient pain therapies. The IPRP at the ACH is a three-week intensive day-treatment intervention provided by an interdisciplinary team, which helps youth resume engagement in normal daily functioning. Following IPRP, youth reported less anxiety, less depressive symptoms, and greater function, although their self-reported pain remained unchanged. In August 2016, the investigators began to explore brain areas related to severe chronic pain in youth. The investigators scanned a subset of youth at the start (baseline) and end (discharge) of IPRP (23 youth with 2 brain scans). From baseline to discharge, the investigators saw decreases in activity in the dorsolateral prefrontal cortex (DLPFC). Decrease in DLPFC activity was related to better mental health outcomes. The DLPFC is a well-known target for non-invasive brain stimulation. Repeated brain stimulation has been used to treat adults, but not youth with chronic pain. For the first time, the investigators will use image-guided brain stimulation (37 minutes/day, 5 days/week) to enhance the brain changes observed with IPRP. The investigators will examine whether three weeks of brain stimulation helps to reduce pain symptoms in youth. The investigators will also compare pain, brain, and mental health outcomes to our historical program data. By adding brain stimulation to our pain intervention, the investigators have the chance to target an area of the brai…
Study details
- Official title
- Can Brain Stimulation Enhance Outcomes Associated With Intensive Rehabilitation for Youth With Chronic Pain?
- Conditions
- Interventions
- Device: Repeated Transcranial Magnetic Stimulation (rTMS)
- Other: Intensive Pain Rehabilitation Program (IPRP)
- Sponsor
- University of Calgary
- Start date
- 2020-10-19
- Primary completion
- 2028-04-30
- Sex
- All
- Age range
- from 10 Years to 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- Canada
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Between the ages of 10-18 years * Patient has had the appropriate medical work-up * Participation in accessible, evidenced based pain therapies has not demonstrated return to functional goals * Pain is significantly impacting the patient's life and they are not meeting their functional goals in areas of life, which may include: physical function, sleep, self-care, school attendance/academic performance, social function, recreational engagement, and mood * Patient and family agree and understand that an active, self-management approach to functional restoration is the mainstay of treatment in the IPRP Exclusion Criteria: * Significant developmental delay or brain injury * Functional neurological disorder/conversion disorder * Youth who require opioid weaning * Extensive medical needs and/or untreated psychiatric illness that would impede a rehabilitative approach to care.
Canadian sites (1)
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04561401