Personalized Transcranial Magnetic Stimulation for Neck Pain

(PrTMS Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Oluwaseyi Gbade-Alabi, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Henry M. Jackson Foundation for the Advancement of Military Medicine

Must be taking: Anticonvulsants

Must not be taking: Antivirals, Antipsychotics, Sedatives

Disqualifiers: Seizure, Bipolar, Schizophrenia, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This study aims to assess the efficacy of Personalized Repetitive Transcranial Magnetic Stimulation (PrTMS) therapy to reduce chronic neck for military health system beneficiaries.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are using medications that lower the seizure threshold without anticonvulsants. It's best to discuss your specific medications with the trial team.

What data supports the effectiveness of the treatment Personalized Repetitive Transcranial Magnetic Stimulation (PrTMS) for neck pain?

Research shows that repetitive transcranial magnetic stimulation (rTMS) can provide relief for some individuals with chronic pain, including neuropathic pain, which is pain caused by nerve damage. While the exact parameters for optimal effectiveness are still being studied, rTMS has been found to be more effective for pain originating from the central nervous system than from peripheral sources.

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Is personalized transcranial magnetic stimulation generally safe for humans?

Repetitive transcranial magnetic stimulation (rTMS), which is similar to personalized transcranial magnetic stimulation, has been studied for safety in various conditions like depression and obesity. Most studies report a reassuring safety profile, with both severe and mild adverse events (unwanted effects) being rare.

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How is Personalized Transcranial Magnetic Stimulation (PrTMS) different from other treatments for neck pain?

Personalized Transcranial Magnetic Stimulation (PrTMS) is unique because it uses electromagnetic principles to create small electrical currents in the brain, potentially providing pain relief by making changes in the central nervous system. Unlike standard treatments, PrTMS is tailored to the individual, aiming to improve effectiveness for each patient.

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Eligibility Criteria

This trial is for military health system beneficiaries suffering from chronic neck pain. Specific eligibility criteria are not provided, but typically participants would need to meet certain health conditions and agree to the study's procedures.

Inclusion Criteria

Military health care beneficiary for enrollment

I have had chronic neck pain for at least 3 months.

I am over 18 years old.

Exclusion Criteria

Pregnancy, breastfeeding, or plans to become pregnant during the course of the study

I do not have a diagnosis of insomnia.

I am taking antiviral or antipsychotic medications.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline

Baseline measurements are taken to establish initial conditions and create comparable groups for treatment

1 week

1 visit (in-person)

Treatment Phase 1

Participants receive PrTMS therapy in addition to standard of care

4 weeks

4 visits (in-person)

Treatment Phase 2

Continuation of PrTMS therapy with ongoing assessments

4 weeks

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 weeks

3 visits (in-person)

Participant Groups

The effectiveness of Personalized Repetitive Transcranial Magnetic Stimulation (PrTMS) in reducing chronic neck pain is being tested. Some participants will receive PrTMS while others will get a sham treatment, which does not have any therapeutic effect, for comparison.

Group I: Sham Personalized Repetitive Transcranial Magnetic Stimulation Experimental Treatment 1 Intervention

Group II: Personalized Repetitive Transcranial Magnetic Stimulation Experimental Treatment 1 Intervention

Personalized Repetitive Transcranial Magnetic Stimulation is already approved in United States for the following indications:

🇺🇸 Approved in United States as PrTMS for:

• Major Depressive Disorder
• Obsessive-Compulsive Disorder
• Pain associated with certain migraine headaches

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Walter Reed National Military Medical Center Bethesda, MD

Who Is Running the Clinical Trial?

Henry M. Jackson Foundation for the Advancement of Military Medicine Lead Sponsor

Uniformed Services University of the Health Sciences Collaborator

Walter Reed National Military Medical Center Collaborator

References

1. England pubmed.ncbi.nlm.nih.gov

Beyond trial-and-error: Individualizing therapeutic transcranial neuromodulation for chronic pain. [2023] Repetitive transcranial magnetic stimulation (rTMS) applied to the motor cortex provides supplementary relief for some individuals with chronic pain who are refractory to pharmacological treatment. As rTMS slowly enters treatment guidelines for pain relief, its starts to be confronted with challenges long known to pharmacological approaches: efficacy at the group-level does not grant pain relief for a particular patient. In this review, we present and discuss a series of ongoing attempts to overcome this therapeutic challenge in a personalized medicine framework.

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

Repetitive transcranial magnetic stimulation in chronic pain: a review of the literature. [2022] To review the literature on the analgesic effects of repetitive transcranial magnetic stimulation (rTMS) in chronic pain according to different pain syndromes and stimulation parameters.

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

High Frequency Repetitive Transcranial Magnetic Stimulation Therapy For Chronic Neuropathic Pain: A Meta-analysis. [2018] Increasing evidence supports an analgesic effect of repetitive transcranial magnetic stimulation (rTMS) for neuropathic pain (NP). However, the optimal parameters of rTMS (stimulation frequency and treatment sessions) for achieving long-term analgesic effects remain unknown. This study analyzed the current findings in the literature.

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

rTMS for suppressing neuropathic pain: a meta-analysis. [2022] This pooled individual data (PID)-based meta-analysis collectively assessed the analgesic effect of repetitive transcranial magnetic stimulation (rTMS) on various neuropathic pain states based on their neuroanatomical hierarchy. Available randomized controlled trials (RCTs) were screened. PID was coded for age, gender, pain neuroanatomical origins, pain duration, and treatment parameters analyses. Coded pain neuroanatomical origins consist of peripheral nerve (PN); nerve root (NR); spinal cord (SC); trigeminal nerve or ganglion (TGN); and post-stroke supraspinal related pain (PSP). Raw data of 149 patients were extracted from 5 (1 parallel, 4 cross-over) selected (from 235 articles) RCTs. A significant (P 1 and 10 Hz) appears to generate better analgesic outcome. In short, rTMS appears to be more effective in suppressing centrally than peripherally originated neuropathic pain states.

5. 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] To show that repetitive transcranial magnetic stimulation (rTMS) delivered at high frequency over the motor cortex can improve patients with chronic pain syndrome even if this procedure does not provide an analgesic response.

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

Safety, Tolerability, and Nocebo Phenomena During Transcranial Magnetic Stimulation: A Systematic Review and Meta-Analysis of Placebo-Controlled Clinical Trials. [2022] The methodology used for the application of repetitive transcranial magnetic stimulation (TMS) is such that it may induce a placebo effect. Respectively, adverse events (AEs) can occur when using a placebo, a phenomenon called nocebo. The primary aim of our meta-analysis is to establish the nocebo phenomena during TMS. Safety and tolerability of TMS were also studied.

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

Adverse events of repetitive transcranial magnetic stimulation in older adults with depression, a systematic review of the literature. [2021] In the last decade, repetitive transcranial magnetic stimulation (rTMS) has been introduced as a non-invasive neuromodulation therapy for depression. Little is known, however, about (serious) adverse events (AE) of rTMS in older adults with a depression. In this article, we want to study what is known about (serious) AE of rTMS in older adults (>60 years) with late-life depression (LLD).

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

Effects of a 2- to 4-week course of repetitive transcranial magnetic stimulation (rTMS) on neuropsychologic functioning, electroencephalogram, and auditory threshold in depressed patients. [2019] The safety of repetitive transcranial magnetic stimulation (rTMS) has only previously been formally studied in volunteers receiving a single session of stimulation or in a small number of depressed subjects receiving a 2-week treatment course. This study examined safety issues in depressed subjects receiving up to 4 weeks of rTMS. Efficacy results from this study have been previously reported.

9. Netherlands pubmed.ncbi.nlm.nih.gov

Assessment of safety of self-controlled repetitive trans-vertebral magnetic stimulation. [2021] The aim of this study was to assess safety issues of self-controlled repetitive trans-vertebral magnetic stimulation (rTVMS) in humans.

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

Safety and tolerability of repeated sessions of deep transcranial magnetic stimulation in obesity. [2021] Repetitive Transcranial Magnetic Stimulation (rTMS) has been demonstrated to be effective in body weight control in individuals with obesity. Most clinical trials on rTMS provided a reassuring safety profile. In the present work, we present an extensive analysis on both severe and mild Adverse Events (AEs) in obese individuals treated with rTMS.

11. Netherlands pubmed.ncbi.nlm.nih.gov

Transcranial magnetic stimulation applications and potential use in chronic pain: studies in waiting. [2019] Transcranial magnetic stimulation (TMS) is a new technology which uses electromagnetic principles to produce small electrical currents in the cortex. Evidence indicates that TMS can produce plastic changes in the CNS which are observable at both the cellular and physiological levels. It is proposed that studies are justified to determine whether TMS can provide short-term or long-term relief in chronic pain.