NCT06214949 · Henry M. Jackson Foundation for the Advancement of Military Medicine
Personalized Repetitive Transcranial Magnetic Stimulation (PrTMS)
(PrTMS)
What this study is about
This study aims to assess the effectiveness of Personalized Repetitive Transcranial Magnetic Stimulation (PrTMS) therapy to reduce chronic neck for military health system beneficiaries.
View original scientific description
This study aims to assess the efficacy of Personalized Repetitive Transcranial Magnetic Stimulation (PrTMS) therapy to reduce chronic neck for military health system beneficiaries.
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.
Primary outcome measures
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
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
- Antiviral medications and antipsychotic medications
- Recent withdrawal from sedatives
- 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.
Where
- Bethesda, Maryland
Collaborators
Uniformed Services University of the Health Sciences, Walter Reed National Military Medical Center
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 6, 2025 · Source of record for eligibility and locations