Summary

Eligibility
for people ages 18-65 (full criteria)
Location
at San Diego, California
Dates
study started
estimated completion
Principal Investigator
by Albert Y Leung, MD
Headshot of Albert Y Leung
Albert Y Leung

Description

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.

Official Title

Combined Nonpharmacological Therapies for MTBI-Related Headaches

Details

This study will be enrolling a total of 240 veterans or active military over a 4 year period at the VA San Diego Healthcare System (VASDHS). Participants will be randomized into one of four groups: Group A: active rTMS with telehealth headache management therapy Group B: active rTMS with telehealth headache education control Group C: sham rTMS with telehealth headache management therapy Group D: sham rTMS with telehealth headache education control Individual participation will consist of 19 visits to the VASDHS and 11 telehealth sessions over the course of 6-7 months. The in person visits will be divided into the following phases: 1. PRE-TREATMENT ASSESSMENTS PHASE (weeks 1-2) which consists of Visit 1 (Screening Visit) and Visit 2 (Baseline Assessments with MRI scan); 2. INDUCTION TREATMENT PHASE (weeks 3-4) consists of Visits 3-12 (10 weekday neuronavigation guided rTMS sessions at >24 and <72 hours apart); and 3. POST-TREATMENT ASSESSMENTS AND MAINTENANCE TREATMENT PHASE (weeks 5-24) consists of 4 initial biweekly post-induction treatment assessments and maintenance treatments (Visits 13-16)) and two additional monthly post-induction assessments and maintenance treatments (Visits 17-18) and one final study visit (Visit 19). Eight weekly telehealth therapy/education sessions will be conducted from week 3 to 10 with additional three bolster sessions at 4 weeks apart. During the baseline and follow up visits, assessments will be conducted to evaluate headaches, neurobehavioral symptoms, depressive symptoms, post-concussion symptoms, and quality of life.

Keywords

TBI (Traumatic Brain Injury), Headache, Depression, rTMS, transcranial magnetic stimulation, therapy, Brain Injuries, Brain Injuries, Traumatic, Active rTMS, Headache Management Therapy

Eligibility

You can join if…

Open to people ages 18-65

  1. Mild Traumatic Brain Injury (mTBI)
  2. Chronic headaches > 3 months after injury
  3. Aged 18-65
  4. No prior TMS treatment
  5. Persistent Headaches with an intensity > 30 / 100
  6. No history of daily headache prior to mTBI

You CAN'T join if...

  1. Pregnant
  2. Pacemaker or any metal in body that would prevent MRI
  3. History of dementia or major psychiatric disease, such as bipolar disorder or schizophrenia
  4. Presence of any other chronic neuropathic pain states
  5. History of seizure
  6. Pending litigation
  7. Can't understand English
  8. History of chronic headache like migraine prior to mTBI
  9. Evidence in chart of exacerbation of depressive/anxiety symptoms, active substance dependence, suicidal intent or attempt within previous month

Location

  • VA San Diego Healthcare System accepting new patients
    San Diego California 92161 United States

Lead Scientist at UCSD

  • Albert Y Leung, MD
    Clinical Professor, Anesthesiology, Vc-health Sciences-schools. Authored (or co-authored) 34 research publications. Research interests: Neuromodulation · Non-invasive Neuromodulation · Transcranial Magnetic Stimulation · Transcutaneous Magnetic Stimulation · Post-traumatic Brain Injury Headache · Non-pharmacological Treatment for Headaches · Neuropathic Pain · Trigeminal Neuralgia

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Veterans Medical Research Foundation
ID
NCT05176392
Study Type
Interventional
Participants
Expecting 240 study participants
Last Updated