Status:
RECRUITING
Personalized Repetitive Transcranial Magnetic Stimulation (PrTMS)
Lead Sponsor:
Henry M. Jackson Foundation for the Advancement of Military Medicine
Collaborating Sponsors:
Uniformed Services University of the Health Sciences
Walter Reed National Military Medical Center
Conditions:
Neck Pain
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief 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.
Detailed Description
The objective of our proposed research is to (a) assess the efficacy of PrTMS therapy in reducing pain for military health system beneficiaries with chronic neck pain receiving standard of care\* at W...
Eligibility Criteria
Inclusion
- Military health care beneficiary for enrollment.
- Over the age of 18 years.
- Presence of chronic neck pain for at least 3 months.
Exclusion
- 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.
Key Trial Info
Start Date :
May 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2027
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06214949
Start Date
May 1 2024
End Date
May 1 2027
Last Update
March 6 2025
Active Locations (1)
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1
Walter Reed National Military Medical Center
Bethesda, Maryland, United States, 20889