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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether Personalized Repetitive Transcranial Magnetic Stimulation (PrTMS) can reduce chronic neck pain. It involves two groups: one receiving the actual treatment and another receiving a sham (inactive) version for comparison. The trial seeks military health system beneficiaries who have experienced chronic neck pain for at least three months.

As an unphased trial, it offers participants the chance to contribute to innovative research that could lead to new treatment options for chronic neck pain.

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 prior data suggests that Personalized Repetitive Transcranial Magnetic Stimulation is safe for reducing neck pain?

Research has shown that repetitive transcranial magnetic stimulation (rTMS) is generally safe and can help reduce certain types of pain. Current studies indicate that rTMS effectively reduces drug-resistant nerve pain, offering hope for its use in other conditions like chronic neck pain.

Experts have updated safety guidelines for rTMS, ensuring its safe application in both research and medical settings. Reports suggest that most people tolerate rTMS well, experiencing only mild side effects such as headaches or slight discomfort at the treatment site, while serious side effects remain rare.

For those considering joining this trial for neck pain, the existing evidence on safety appears promising. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about personalized transcranial magnetic stimulation (TMS) for neck pain because it offers a non-invasive approach that precisely targets the brain's pain processing areas. Unlike traditional treatments like medication or physical therapy, which can have varying effectiveness and side effects, personalized TMS is tailored to each individual's unique brain patterns, potentially leading to more effective pain relief. Additionally, the sham version helps ensure that any improvements are due to the treatment itself, not just a placebo effect, which could pave the way for more accurate and reliable pain management strategies.

What evidence suggests that Personalized Repetitive Transcranial Magnetic Stimulation could be effective for neck pain?

Research has shown that personalized repetitive transcranial magnetic stimulation (PrTMS), a treatment available in this trial, might help reduce chronic neck pain. One study found that 42% of patients who underwent several sessions of a similar treatment reported more than 30% relief from their pain. This indicates that PrTMS could effectively manage pain. Additionally, this type of magnetic stimulation has alleviated symptoms of other conditions, supporting its potential for neck pain. Overall, these findings suggest that PrTMS could be a promising option for individuals suffering from chronic neck pain. ^{1 2 4 5 6}

Who Is on the Research Team?

Oluwaseyi Gbade-Alabi, MD

Principal Investigator

Uniformed Services University of the Health Sciences

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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 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]

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]

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) 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) 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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06214949?intr=PRTMS&rank=2

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

2. withpower.com withpower.com/trial/phase-neck-pain-1-2024-cc40f

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

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11629460/

Effects of multiple transcranial magnetic stimulation sessions ... In total, 193 patients completed test period of 4 rTMS sessions and 42% of them reported a pain relief (PR) greater than 30%, with concurrent ...

4. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06214949/personalized-repetitive-transcranial-magnetic-stimulation-prtms

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

5. aetna.com aetna.com/cpb/medical/data/400_499/0469.html

Transcranial Magnetic Stimulation and Cranial Electrical ... TMS or tDCS combined with MAT significantly reduced craving-related measures relative to sham stimulation (Hedges' g = -0.42, CI: -0.73 to -0.11, p < 0.01).

6. sciencedirect.com sciencedirect.com/science/article/pii/S1388245720305149

Safety and recommendations for TMS use in healthy ... The meeting intended to update the ten-year-old safety guidelines for the application of transcranial magnetic stimulation (TMS) in research and clinical ...