What is the mechanism of action of this treatment?

Common treatments for chronic pain, such as neuromodulation techniques, work by targeting specific brain regions involved in pain processing and modulation. For example, Image-Guided Brain Stimulation focuses on the dorsolateral prefrontal cortex (DLPFC), a key area in pain perception and emotional regulation. By altering the activity in the DLPFC, these treatments can reduce pain perception and improve mental health outcomes. This is crucial for chronic pain patients as it provides a non-invasive alternative to traditional pain management methods, potentially offering better long-term relief without the side effects of medications.

What side effects are associated with this type of intervention?

Common treatments for chronic pain, such as transcranial magnetic stimulation (TMS) and transcranial direct current stimulation (tDCS), generally have mild side effects. These can include headaches, scalp discomfort, tingling, and dizziness. More serious adverse events are rare but can include seizures, particularly in patients with epilepsy. Pharmacological treatments, such as anticonvulsants and antidepressants, may cause side effects like drowsiness, weight gain, and gastrointestinal issues. Interventional procedures, including nerve blocks and epidural steroid injections, can lead to temporary pain at the injection site, infection, and, in rare cases, nerve damage.

What prior FDA approvals exist?

The FDA has approved several neuromodulation techniques for the treatment of chronic pain. Transcranial magnetic stimulation (TMS), which targets the dorsolateral prefrontal cortex (DLPFC), is one such treatment. TMS has been approved for conditions like major depressive disorder, which often coexists with chronic pain, and there is growing evidence supporting its use in pain management. Additionally, spinal cord stimulation (SCS) has been approved for chronic pain conditions such as failed back surgery syndrome and complex regional pain syndrome. These treatments align with the neuromodulation approaches being studied in trials involving image-guided brain stimulation.

What other types of research exist?

Promising novel alternatives to Image-Guided Brain Stimulation for chronic pain patients include: 1) Transcranial Magnetic Stimulation (TMS), which has shown efficacy in reducing pain and improving mental health outcomes; 2) Transcranial Direct Current Stimulation (tDCS), which has been effective in modulating pain and enhancing neurocognition; 3) Spinal Cord Stimulation (SCS), which has demonstrated benefits in managing neuropathic pain and chronic pain conditions; and 4) Mind-Body Therapies such as yoga and Qigong massage, which have shown improvements in pain management and overall functioning.

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IPRP + rTMS for Chronic Pain

N/A

Recruiting

Led By Jillian V Miller, PhD

Research Sponsored by University of Calgary

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Between the ages of 10-18 years

Be younger than 65 years old

Must not have

Functional neurological disorder/conversion disorder

Youth who require opioid weaning

Timeline

Screening 3 weeks

Treatment Varies

Follow Up this outcome will be measured at day 11.

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While not specified here, common side effects of rTMS may include headache, scalp discomfort at the stimulation site, tingling or spasms of facial muscles, lightheadedness, and rare risk of seizure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 10 and 18 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with a functional neurological disorder.

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

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ this outcome will be measured at day 11.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~this outcome will be measured at day 11.

This trial's timeline: 3 weeks for screening, Varies for treatment, and this outcome will be measured at day 11. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Anxiety

Brain imaging

Functional disability

+7 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: rTMS + IPRPExperimental Treatment2 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: IPRPActive Control1 Intervention

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

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for chronic pain, such as neuromodulation techniques, work by targeting specific brain regions involved in pain processing and modulation. For example, Image-Guided Brain Stimulation focuses on the dorsolateral prefrontal cortex (DLPFC), a key area in pain perception and emotional regulation. By altering the activity in the DLPFC, these treatments can reduce pain perception and improve mental health outcomes. This is crucial for chronic pain patients as it provides a non-invasive alternative to traditional pain management methods, potentially offering better long-term relief without the side effects of medications.

Effectiveness of repetitive trancranial or peripheral magnetic stimulation in neuropathic pain.Long-term experience of neuromodulation in TACs.