Combined Transcranial Magnetic Stimulation and Therapy for MTBI Related Headaches
Recruiting · NCT05176392 · Interventional (participants receive a specific treatment) · Lead sponsor: Veterans Medical Research Foundation
View the official record on ClinicalTrials.gov →Interventions studied
Active rTMSHeadache Education ControlHeadache Management TherapySham rTMS
What this trial is about
This study will assess the combined effectiveness of repetitive transcranial magnetic stimulation (rTMS) and telehealth based therapy in helping manage mild traumatic brain injury (mTBI) related headaches. The investigators hypothesize that active rTMS combined with telehealth therapy will provide marked reduction in mTBI related headaches and symptoms in comparison to their placebo counterparts.
Who can take part
Age range
18 Years to 65 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Mild Traumatic Brain Injury (mTBI)
- Chronic headaches \> 3 months after injury
- Aged 18-65
- No prior TMS treatment
- Persistent Headaches with an intensity \> 30 / 100
- No history of daily headache prior to mTBI
Exclusion criteria
- Pregnant
- Pacemaker or any metal in body that would prevent MRI
- History of dementia or major psychiatric disease, such as bipolar disorder or schizophrenia
- Presence of any other chronic neuropathic pain states
- History of seizure
- Pending litigation
- Can't understand English
- History of chronic headache like migraine prior to mTBI
- Evidence in chart of exacerbation of depressive/anxiety symptoms, active substance dependence, suicidal intent or attempt within previous month
Where it is running
1 location listed across 1 US state.
- VA San Diego Healthcare System - San Diego, California, United States