Personalized Repetitive Transcranial Magnetic Stimulation (PrTMS)

NARecruitingINTERVENTIONAL
Enrollment

120

Participants

Timeline

Start Date

May 1, 2024

Primary Completion Date

May 31, 2027

Study Completion Date

May 31, 2027

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.

Trial Locations (1)

20889

RECRUITING

Walter Reed National Military Medical Center, Bethesda

All Listed Sponsors
collaborator

Uniformed Services University of the Health Sciences

FED

collaborator

Walter Reed National Military Medical Center

FED

lead

Henry M. Jackson Foundation for the Advancement of Military Medicine

OTHER