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Personalized Transcranial Magnetic Stimulation for Neck Pain (PrTMS Trial)
N/A
Recruiting
Led By Oluwaseyi Gbade-Alabi, MD
Research Sponsored by Henry M. Jackson Foundation for the Advancement of Military Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Presence of chronic neck pain for at least 3 months
Be older than 18 years old
Must not have
Participants must not have a clinical diagnosis of insomnia
Unstable heart or pulmonary disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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 will be taken once at end of baseline, phase 1 and phase 2 and at 2, 4, and 8 weeks in follow-up
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a therapy called Personalized Repetitive Transcranial Magnetic Stimulation (PrTMS) to see if it can help reduce chronic neck pain in military health system beneficiaries.
Who is the study for?
This trial is for military health system beneficiaries suffering from chronic neck pain. Specific eligibility criteria are not provided, but typically participants would need to meet certain health conditions and agree to the study's procedures.
What is being tested?
The effectiveness of Personalized Repetitive Transcranial Magnetic Stimulation (PrTMS) in reducing chronic neck pain is being tested. Some participants will receive PrTMS while others will get a sham treatment, which does not have any therapeutic effect, for comparison.
What are the potential side effects?
While specific side effects are not listed, common ones associated with TMS may include headache, scalp discomfort at the site of stimulation, tingling or spasms of facial muscles.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had chronic neck pain for at least 3 months.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have a diagnosis of insomnia.
Select...
I do not have unstable heart or lung conditions.
Select...
I have not had a brain tumor, brain infection, stroke, or penetrating brain injury.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 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 will be taken once at end of baseline, phase 1 and phase 2 and at 2, 4, and 8 weeks in follow-up
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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 will be taken once at end of baseline, phase 1 and phase 2 and at 2, 4, and 8 weeks in follow-up
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Defense & Veterans Pain Rating Scale (DVPRS)
Secondary study objectives
Demographics Survey
Generalized Anxiety Disorder 7-item scale (GAD-7)
Insomnia Severity Index (ISI)
+10 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Sham Personalized Repetitive Transcranial Magnetic StimulationExperimental Treatment1 Intervention
Group II: Personalized Repetitive Transcranial Magnetic StimulationExperimental Treatment1 Intervention
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Who is running the clinical trial?
Henry M. Jackson Foundation for the Advancement of Military MedicineLead Sponsor
98 Previous Clinical Trials
93,635 Total Patients Enrolled
Oluwaseyi Gbade-Alabi, MDPrincipal InvestigatorUniformed Services University of the Health Sciences
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