Personalized Transcranial Magnetic Stimulation for Neck Pain

(PrTMS Trial)

Overseen By Miana F Atkins, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

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

Compensation: Varies

Number of Visits: 12

120 Participants Needed

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. ^{1 2 3 4 5}

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. ^{6 7 8 9 10}

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. ^{1 2 3 4 11}

Research Team

Oluwaseyi Gbade-Alabi, MD

Principal Investigator

Uniformed Services University of the Health Sciences

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.

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)

Treatment Details

Interventions

• Personalized Repetitive Transcranial Magnetic Stimulation
• Sham Personalized Repetitive Transcranial Magnetic Stimulation

Trial Overview 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.

Participant Groups

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

Who Is Running the Clinical Trial?

Henry M. Jackson Foundation for the Advancement of Military Medicine

Lead Sponsor

Trials

103

Recruited

94,300+

Uniformed Services University of the Health Sciences

Collaborator

Trials

130

Recruited

91,100+

Walter Reed National Military Medical Center

Collaborator

Trials

149

Recruited

33,800+

Findings from Research

Repetitive transcranial magnetic stimulation (rTMS) shows promise as a non-invasive treatment for chronic pain, particularly for patients who do not respond to traditional medications, but its effectiveness can vary significantly between individuals.

Current strategies to personalize rTMS treatment include assessing individual brain networks and modifying stimulation patterns, although most of these approaches have only moderate evidence supporting their efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Beyond trial-and-error: Individualizing therapeutic transcranial neuromodulation for chronic pain. Ciampi de Andrade, D., García-Larrea, L.[2023]

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]

High-frequency repetitive transcranial magnetic stimulation (HF-rTMS) is effective in reducing neuropathic pain, with significant pain relief observed after just one and five treatment sessions, based on a meta-analysis of 25 studies involving 589 patients.

The analgesic effects of HF-rTMS can last for at least one month after five sessions, indicating its potential for long-term pain management in neuropathic pain patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High Frequency Repetitive Transcranial Magnetic Stimulation Therapy For Chronic Neuropathic Pain: A Meta-analysis. Jin, Y., Xing, G., Li, G., et al.[2018]

Repetitive transcranial magnetic stimulation (rTMS) significantly reduces neuropathic pain, with a notable overall analgesic effect compared to sham treatment, as shown in a meta-analysis of 149 patients from 5 randomized controlled trials.

The greatest pain relief was observed in patients with trigeminal nerve pain (28.8% reduction), followed by post-stroke pain (16.7%) and spinal cord pain (14.7%), indicating that rTMS is more effective for centrally originated pain compared to peripheral sources.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

rTMS for suppressing neuropathic pain: a meta-analysis. Leung, A., Donohue, M., Xu, R., et al.[2022]

In a case study of a 77-year-old woman with chronic neuropathic pain, high-frequency repetitive transcranial magnetic stimulation (rTMS) improved her quality of life, anxiety, depression, and walking ability, despite no change in pain intensity.

The results suggest that rTMS may enhance daily functioning in chronic pain patients by influencing brain circuits, indicating its potential therapeutic benefits beyond just pain relief.

NCBI (Pubmed)

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. Hodaj, H., Payen, JF., Lefaucheur, JP.[2018]

In a meta-analysis of 93 randomized controlled trials involving repetitive transcranial magnetic stimulation (TMS), the overall incidence of adverse events (AEs) was found to be higher in the active TMS group (29.3%) compared to the placebo group (13.6%), indicating a 2.60 times greater risk of experiencing AEs with active treatment.

Despite the higher incidence of AEs, TMS is considered a safe and well-tolerated intervention, with common side effects including headache and dizziness, highlighting the importance of recognizing nocebo effects in both clinical trials and practice.

NCBI (Pubmed)

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. Zis, P., Shafique, F., Hadjivassiliou, M., et al.[2022]

Repetitive transcranial magnetic stimulation (rTMS) is generally safe for older adults with late-life depression, with only 12.4% reporting any adverse events and serious adverse events occurring in just 1.5% of cases, based on a review of 11 studies involving 353 patients.

The most common adverse events were mild, such as headaches (6.9%) and discomfort at the stimulation site (2.7%), although some serious adverse events, including psychiatric hospitalization and increased suicidal ideation, were noted in case reports, highlighting the need for further research to ensure safety in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events of repetitive transcranial magnetic stimulation in older adults with depression, a systematic review of the literature. Overvliet, GM., Jansen, RAC., van Balkom, AJLM., et al.[2021]

In a study involving 18 subjects with major depression, repetitive transcranial magnetic stimulation (rTMS) for up to 4 weeks was found to be generally safe, with no significant mean deficits in neuropsychologic function or auditory thresholds.

However, two patients experienced mild high-frequency hearing loss, indicating that while rTMS is safe for most, individual responses may vary and warrant further investigation into long-term safety.

NCBI (Pubmed)

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. Loo, C., Sachdev, P., Elsayed, H., et al.[2019]

Self-controlled repetitive trans-vertebral magnetic stimulation (rTVMS) was found to be safe, with no serious adverse events reported in a study involving 30 healthy volunteers and 12 patients with spinal cord disorders across 1690 trials.

While minor discomfort was reported in about 10% of trials, rTVMS did not significantly affect blood pressure in patients and even increased peripheral oxygen saturation in healthy volunteers, suggesting its potential for safe use in both research and treatment settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of safety of self-controlled repetitive trans-vertebral magnetic stimulation. Sasada, S., Kadowaki, S., Tazoe, T., et al.[2021]

In a study of 63 obese individuals undergoing a 5-week rTMS treatment for weight control, the treatment showed a reassuring safety profile with no unexpected adverse events reported up to one year after treatment.

The most common side effects were moderate headaches (40.4%) and local pain/discomfort (19.2%), particularly more frequent in the high-frequency rTMS group, but overall, rTMS was well tolerated in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and tolerability of repeated sessions of deep transcranial magnetic stimulation in obesity. Ferrulli, A., Massarini, S., Macrì, C., et al.[2021]

Transcranial magnetic stimulation (TMS) uses electromagnetic principles to create electrical currents in the brain, which can lead to lasting changes in the central nervous system (CNS).

There is a need for further research to explore the potential of TMS in providing both short-term and long-term relief for chronic pain conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial magnetic stimulation applications and potential use in chronic pain: studies in waiting. Pridmore, S., Oberoi, G.[2019]

References

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

Beyond trial-and-error: Individualizing therapeutic transcranial neuromodulation for chronic pain. [2023]

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

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

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

High Frequency Repetitive Transcranial Magnetic Stimulation Therapy For Chronic Neuropathic Pain: A Meta-analysis. [2018]

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

rTMS for suppressing neuropathic pain: a meta-analysis. [2022]

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]

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]

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]

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]

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

Assessment of safety of self-controlled repetitive trans-vertebral magnetic stimulation. [2021]

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

Safety and tolerability of repeated sessions of deep transcranial magnetic stimulation in obesity. [2021]

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

Transcranial magnetic stimulation applications and potential use in chronic pain: studies in waiting. [2019]