This study aims to assess the efficacy of Personalized Repetitive Transcranial Magnetic Stimulation (PrTMS) therapy to reduce chronic neck for military health system beneficiaries.
Military health care beneficiary for enrollment.
Over the age of 18 years.
Presence of chronic neck pain for at least 3 months.
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.
Parallel
Personalized Repetitive Transcranial Magnetic Stimulation
DeviceTreatment 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
DeviceTreatment 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.
Defense & Veterans Pain Rating Scale (DVPRS)
The DVPRS was developed to standardize pain measurement across all health care settings and promote pain assessment and reassessment practices. DVPRS is a visual pain scale to assess individual's pain intensity on a scale of 0-10, with an additional 4 questions to assess pain's interference with the participant's activity, sleep, mood, and stress. The scale has excellent internal reliability and test-retest reliability.
Patient Global Impression of Change (PGIC)
The PGIC outcome measure evaluates a patient's self-reported level of pain and their feelings about treatment effectiveness to determine symptom improvement using a 7 point scale from 1-7. Higher scores indicate a greater improvement while lower scores indicate less improvement or even worsening of a condition.
TMS Tolerability Worksheet (TTW)
The TTW is administered after each PrTMS session to accurately track and record tolerability of TMS therapy as well as frequency and severity of the known minor negative side effects of TMS, such as headaches.
Pain Anxiety Symptom Scale Short Form 20 (PASS)
The PASS measures anxiety and fear specifically related to pain on a scale from 0 (never) to 5 (always).
Sleep Condition Indicator (SCI)
The SCI is an 8-item self-report measure that evaluates insomnia disorder where answers to a given item are weighted from 0 (affected sleep) to 4 (no affected sleep). A higher score is indicative of better sleep.
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Henry M. Jackson Foundation for the Advancement of Military Medicine
Lead sponsor
Uniformed Services University of the Health Sciences
Collaborator
Walter Reed National Military Medical Center
Collaborator
