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Personalized Repetitive Transcranial Magnetic Stimulation (PrTMS)

NCT06214949 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2025-03-06

No results posted yet for this study

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

Interventions

DEVICE

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.

DEVICE

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.

Sponsors & Collaborators

  • Uniformed Services University of the Health Sciences

    collaborator FED

  • Walter Reed National Military Medical Center

    collaborator FED

  • Henry M. Jackson Foundation for the Advancement of Military Medicine

    lead OTHER

Principal Investigators

  • Oluwaseyi Gbade-Alabi, MD · Uniformed Services University of the Health Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-01
Primary Completion
2027-05-31
Completion
2027-05-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06214949 on ClinicalTrials.gov