Personalized Repetitive Transcranial Magnetic Stimulation (PrTMS)

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
Henry M. Jackson Foundation for the Advancement of Military Medicine
Study ID
NCT06214949
Status
Recruiting
Apply to this trial

Conditions

  • Neck Pain

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Personalized Repetitive Transcranial Magnetic Stimulation — DEVICE
    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 — DEVICE
    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.

Study Details

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

Key Dates

Start date
May 1, 2024
Status verified
Mar 2025
Primary completion
May 31, 2027
Completion
May 31, 2027

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Personalized Repetitive Transcranial Magnetic Stimulation
  • Experimental: Sham Personalized Repetitive Transcranial Magnetic Stimulation

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

Locations (1)

FacilityCityStateZIPSite coordinators
Walter Reed National Military Medical CenterBethesdaMaryland20889
Oluwaseyi Gbade-Alabi, MD
[email protected]
240-688-7145
Miana Atkins, MPH
[email protected]
240-688-7145
Oluwaseyi Gbade-Alabi, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Walter Reed National Military Medical Center· Bethesda, MD

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