Personalized Repetitive Transcranial Magnetic Stimulation for chronic neck pain

Personalized Repetitive Transcranial Magnetic Stimulation (PrTMS) as a Treatment for Chronic Neck Pain

This study is testing if a new therapy called Personalized Repetitive Transcranial Magnetic Stimulation can help military health system beneficiaries with chronic neck pain feel better compared to a fake treatment.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Henry M. Jackson Foundation for the Advancement of Military Medicine (other)
• Locations: 1 site (Bethesda, Maryland)
• Trial ID: NCT06214949 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of Personalized Repetitive Transcranial Magnetic Stimulation (PrTMS) therapy in alleviating chronic neck pain among military health system beneficiaries. Participants will receive either PrTMS therapy combined with standard care or a sham treatment, with their pain levels assessed through both quantitative and qualitative measures. The study also aims to gather insights into participants' perceptions of the treatment and its impact on their pain experience. The research is conducted at Walter Reed National Military Medical Center.

Who should consider this trial

Good fit: Ideal candidates include military health care beneficiaries over 18 years old who have experienced chronic neck pain for at least three months.

Not a fit: Patients with a history of seizure disorders, unstable heart or pulmonary diseases, or certain psychiatric conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce chronic neck pain for military personnel and improve their quality of life.

How similar studies have performed: While the use of PrTMS is a relatively novel approach, similar studies have shown promising results in pain management, suggesting potential for success.

Eligibility criteria

Inclusion Criteria:

* Military health care beneficiary for enrollment.
* Over the age of 18 years.
* Presence of chronic neck pain for at least 3 months.

Exclusion Criteria:

* History of seizure, bipolar disorder, or schizophrenia.
* Unstable heart or pulmonary disease.
* Brain tumor, active brain infection, history of cerebral vascular accident (CVA), or penetrating brain injury.
* Use of medications that potentially lower seizure threshold without concomitant administration of anticonvulsant drugs that may protect against seizure occurrence.

  1. Antiviral medications and antipsychotic medications
  2. Recent withdrawal from sedatives
  3. Substance abuse of phencyclidine, amphetamines, ketamine, and gammahydroxybutyrate
* Not a suitable candidate for the study as determined by the PI.
* Pregnancy, breastfeeding, or plans to become pregnant during the course of the study.
* Presence of metallic hardware in close contact to the discharging coil (e.g. cochlear implants, internal pulse generator).
* Presence of implanted brain electrodes (cortical or deep-brain electrodes).
* Potential participants who score above a certain suicide relevant survey score on the Suicide Behaviors Questionnaire-Revised (SBQ-R), or are judged by expert clinicians to be a serious risk of harm to self, will be excluded.
* Participants cannot have undergone a previous TMS treatment within the last 30 days before the start of study treatment.
* Participants must have reliable and consistent access to the internet to complete surveys when not present in the clinic.
* Participants must not have a clinical diagnosis of insomnia.
* Participants can not be actively partaking in a substance abuse program.

Where this trial is running

Bethesda, Maryland

• Walter Reed National Military Medical Center — Bethesda, Maryland, United States (RECRUITING)

Study contacts

• Principal investigator: Oluwaseyi Gbade-Alabi, MD — Uniformed Services University of the Health Sciences
• Study coordinator: Oluwaseyi Gbade-Alabi, MD

Conditions: Neck Pain