Combined Nonpharmacological Therapies for MTBI-Related Headaches
Status: Recruiting
Location: See location...
Intervention Type: Behavioral, Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:
• 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
Locations
United States
California
VA San Diego Healthcare System
RECRUITING
San Diego
Contact Information
Primary
Caleb Lopez, BS
caleb.lopez@va.gov
858-552-8585
Time Frame
Start Date: 2022-01-01
Estimated Completion Date: 2025-08-31
Participants
Target number of participants: 240
Treatments
Active_comparator: Active rTMS with telehealth headache management therapy
Participants receive both active rTMS treatment at the left dorsolateral prefrontal cortex and therapy for headache management
Other: Active rTMS with telehealth headache education control
Participants receive active rTMS treatment at the left dorsolateral prefrontal cortex and headache education
Other: Sham rTMS with telehealth headache management therapy
Participants receive sham rTMS treatment at the left dorsolateral prefrontal cortex and therapy for headache management
Sham_comparator: Sham rTMS with telehealth headache education control
Participants receive sham rTMS treatment at the left dorsolateral prefrontal cortex and headache education
Authors
Related Therapeutic Areas
Sponsors
Leads: Veterans Medical Research Foundation