Personalized Repetitive Transcranial Magnetic Stimulation for chronic neck pain

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: oluwaseyi.gbade-alabi@usuhs.edu
• Phone: 240-688-7145

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.