What this study is
This study aims to assess the efficacy of Personalized Repetitive Transcranial Magnetic Stimulation (PrTMS) therapy to reduce chronic neck for military health system beneficiaries.
What's being tested
- Personalized Repetitive Transcranial Magnetic Stimulation
Intervention · 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
Intervention · 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
- Official title
- Personalized Repetitive Transcranial Magnetic Stimulation (PrTMS) as a Treatment for Chronic Neck Pain
- Sponsor
- Henry M. Jackson Foundation for the Advancement of Military Medicine
- Conditions
- Neck Pain
- Enrolling
- 120 people
- Starts
- 2024-05-01
- Est. completion
- 2027-05
- Design
- Triple-blind, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 65 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- Military health care beneficiary for enrollment.
- Over the age of 18 years.
- Presence of chronic neck pain for at least 3 months.
You can't join if
- 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openWalter Reed National Military Medical Center
Bethesda, Maryland, United States
- Oluwaseyi Gbade-Alabi, MD · Contact240-688-7145oluwaseyi.gbade-alabi@usuhs.edu
- Miana Atkins, MPH · Contact240-688-7145CRSR_Research@usuhs.edu
- Oluwaseyi Gbade-Alabi, MD · Principal investigator
Recruiting
Study team
Sponsor
Henry M. Jackson Foundation for the Advancement of Military Medicine
Study ID 2020-0324
Principal investigator
Oluwaseyi Gbade-Alabi, MD
Uniformed Services University of the Health Sciences
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.