Recruiting

PrTMS

Sponsor:

Henry M. Jackson Foundation for the Advancement of Military Medicine

Code:

NCT06214949

Conditions

Neck Pain

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Personalized Repetitive Transcranial Magnetic Stimulation

Sham Personalized Repetitive Transcranial Magnetic Stimulation

Study Details

Brief summary:

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

Conditions

Neck Pain

Study ID

NCT06214949

Start date

May 1, 2024

Status verified date

Mar, 2025

Completion date

May, 2027

Anticipated

Primary completion date

May, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Personalized Repetitive Transcranial Magnetic Stimulation

experimental: Sham Personalized Repetitive Transcranial Magnetic Stimulation

Interventions

Personalized Repetitive Transcranial Magnetic Stimulation

Treatment will consist of 15 sessions over 3-4 weeks. Specifically, the active or sham treatments will be conducted \~5 times a week during the treatment phase of the study. The treatment protocol parameters (stimulus location, frequency, duration, and intensity) will be derived from the PrTMS software algorithm which incorporates clinical inputs from neurocognitive surveys and quantitative EEG analysis. The mechanical parameters will adhere to the recommended PrTMS parameters for pain treatment: figure of 8 coil that produces biphasic stimulatory pulses to the central zone cortex, frontal zone cortex, Broca's area, and frontal pre-cortex areas at a stimulation depth of 2 cm. Treatment parameters will be unique to each participant but will remain within known ranges. The frequency will be between 8 and 13 Hz, at an amplitude of 20-30% (approximately 30-40% of RMT), and about 3200-7200 pulses per session. Since parameters are specific to each participant, treatment settings will vary.

Sham Personalized Repetitive Transcranial Magnetic Stimulation

Treatment will consist of 15 sessions over the course of 3-4 weeks. More specifically, the active or sham treatments will be conducted roughly 5 times a week during the course of the treatment phase of the study. The TMS system will have three coils, one designated active and the other two unlabeled and identical in appearance, weight, and noises emitted, one of which will be active and one of which will be sham.

Primary outcome measure

  • Defense & Veterans Pain Rating Scale (DVPRS) [ Time Frame: Measured to compare changes from Baseline; during Phase 1 and 2 of treatment; and during the follow up phase after treatment ends up to 8 weeks. Measurements taken everyday during Baseline, Phase 1 and Phase 2 and at 2, 4, and 8 weeks in Follow-Up ]

Central Contacts and Locations

Central contacts

Oluwaseyi Gbade-Alabi, MD

240-688-7145oluwaseyi.gbade-alabi@usuhs.edu

Miana F Atkins, MPH

240-688-7145CRSR_Research@usuhs.edu

Locations

Walter Reed National Military Medical Center

Recruiting

Bethesda, Maryland, United States, 20889

Contacts

Oluwaseyi Gbade-Alabi, MD

240-688-7145oluwaseyi.gbade-alabi@usuhs.edu

Miana Atkins, MPH

240-688-7145CRSR_Research@usuhs.edu

Principal Investigator:

Oluwaseyi Gbade-Alabi, MD

More Information

Sponsor

Henry M. Jackson Foundation for the Advancement of Military Medicine

Last update posted

Mar 6, 2025

Last verified

Mar, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-10. This information was provided to ClinicalTrials.gov by Henry M. Jackson Foundation for the Advancement of Military Medicine on 2025-03-06. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.