Clinical trial NCT05176392: Combined Transcranial Magnetic Stimulation and Therapy for MTBI Related Headaches
Official title: Combined Nonpharmacological Therapies for MTBI-Related Headaches
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: TBI (Traumatic Brain Injury)
Headache
Depression
Keywords: rTMS
transcranial magnetic stimulation
therapy
Lead sponsor: Veterans Medical Research Foundation
Sponsor class: OTHER
First posted: 2022-01-04
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Each participant will be randomized into one of 4 groups. Blocked randomization will be used with random block size of 4 or 8. Participants will be randomized to study groups in a 1:1:1:1 ratio.
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Intensity of Persistent Headaches
timeFrame: Change from baseline to 2-, 4-, 6-, 8-, 12-, 16-, and 20-weeks follow up visit
measure: Intensity of Debilitating Headaches
timeFrame: Change from baseline to 2-, 4-, 6-, 8-, 12-, 16-, and 20-weeks follow up visit
measure: Persistent Headache Frequency
timeFrame: Change from baseline to 2-, 4-, 6-, 8-, 12-, 16-, and 20-weeks follow up visit
measure: Debilitating Headache Frequency
timeFrame: Change from baseline to 2-, 4-, 6-, 8-, 12-, 16-, and 20-weeks follow up visit
measure: Debilitating Headache Interference
timeFrame: Change from baseline to 2-, 4-, 6-, 8-, 12-, 16-, and 20-weeks follow up visit
Secondary outcomes:
measure: Headache Impact Test
timeFrame: Change from baseline to 2-, 4-, 6-, 8-, 12-, 16-, and 20-weeks follow up visit
measure: Neurobehavioral Symptom Inventory
timeFrame: Change from baseline to 2-, 4-, 6-, 8-, 12-, 16-, and 20-weeks follow up visit
measure: Hamilton Rating Scale for Depression
timeFrame: Change from baseline to 2-, 4-, 6-, 8-, 12-, 16-, and 20-weeks follow up visit
measure: Rivermead Post-Concussion Symptoms Questionnaire
timeFrame: Change from baseline to 2-, 4-, 6-, 8-, 12-, 16-, and 20-weeks follow up visit
measure: Short Form Health Survey-36
timeFrame: Change from baseline to 2-, 4-, 6-, 8-, 12-, 16-, and 20-weeks follow up visit
measure: Short-Form NEURO-QoL
timeFrame: Change from baseline to 2-, 4-, 6-, 8-, 12-, 16-, and 20-weeks follow up visit
Other outcomes:
Locations:
city: San Diego
country: United States
facility: VA San Diego Healthcare System
state: California
Study officials:
affiliation: San Diego Veterans Healthcare System
name: Albert Y Leung, MD
role: PRINCIPAL_INVESTIGATOR
References: