Combined Transcranial Magnetic Stimulation and Therapy for MTBI Related Headaches

Veterans Medical Research Foundation

Status: Enrolling

Conditions: Depression; Headache; TBI (Traumatic Brain Injury)

Treatments: Device: Sham rTMS; Device: Active rTMS; Behavioral: Headache Education Control; Behavioral: Headache Management Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05176392

CP200229

H210076 (Other Identifier)

W81XWH2110831 (Other Grant/Funding Number)

Details and patient eligibility

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.

Full 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.

Enrollment: 240 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Triple Blind

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240 participants in 4 patient groups

Active rTMS with telehealth headache management therapy

Active Comparator group

Description:

Participants receive both active rTMS treatment at the left dorsolateral prefrontal cortex and therapy for headache management

Treatment:

Behavioral: Headache Management Therapy

Device: Active rTMS

Active rTMS with telehealth headache education control

Other group

Description:

Participants receive active rTMS treatment at the left dorsolateral prefrontal cortex and headache education

Treatment:

Behavioral: Headache Education Control

Device: Active rTMS

Sham rTMS with telehealth headache management therapy

Other group

Description:

Participants receive sham rTMS treatment at the left dorsolateral prefrontal cortex and therapy for headache management

Treatment:

Behavioral: Headache Management Therapy

Device: Sham rTMS

Sham rTMS with telehealth headache education control

Sham Comparator group

Description:

Participants receive sham rTMS treatment at the left dorsolateral prefrontal cortex and headache education

Treatment:

Behavioral: Headache Education Control

Device: Sham rTMS