Combined Transcranial Magnetic Stimulation and Therapy for MTBI Related Headaches
NCT ID: NCT05176392
Last Updated: 2024-11-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
240 participants
INTERVENTIONAL
2022-01-01
2025-08-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
TRIPLE
Study Groups
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Active rTMS with telehealth headache management therapy
Participants receive both active rTMS treatment at the left dorsolateral prefrontal cortex and therapy for headache management
Active rTMS
Active rTMS will be given at the left dorsolateral prefrontal cortex with a double blind TMS coil.
Headache Management Therapy
Therapy will be provided on headache management.
Active rTMS with telehealth headache education control
Participants receive active rTMS treatment at the left dorsolateral prefrontal cortex and headache education
Active rTMS
Active rTMS will be given at the left dorsolateral prefrontal cortex with a double blind TMS coil.
Headache Education Control
In the control, educational sessions on headaches will be provided.
Sham rTMS with telehealth headache management therapy
Participants receive sham rTMS treatment at the left dorsolateral prefrontal cortex and therapy for headache management
Headache Management Therapy
Therapy will be provided on headache management.
Sham rTMS
Sham rTMS will be given at the left dorsolateral prefrontal cortex. All parameters of the treatment will appear identical to the active treatment, with only the rTMS coil used to administer the treatment flipped 180 degrees to prevent stimulation.
Sham rTMS with telehealth headache education control
Participants receive sham rTMS treatment at the left dorsolateral prefrontal cortex and headache education
Sham rTMS
Sham rTMS will be given at the left dorsolateral prefrontal cortex. All parameters of the treatment will appear identical to the active treatment, with only the rTMS coil used to administer the treatment flipped 180 degrees to prevent stimulation.
Headache Education Control
In the control, educational sessions on headaches will be provided.
Interventions
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Active rTMS
Active rTMS will be given at the left dorsolateral prefrontal cortex with a double blind TMS coil.
Headache Management Therapy
Therapy will be provided on headache management.
Sham rTMS
Sham rTMS will be given at the left dorsolateral prefrontal cortex. All parameters of the treatment will appear identical to the active treatment, with only the rTMS coil used to administer the treatment flipped 180 degrees to prevent stimulation.
Headache Education Control
In the control, educational sessions on headaches will be provided.
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
65 Years
ALL
No
Sponsors
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Veterans Medical Research Foundation
OTHER
Responsible Party
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Principal Investigators
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Albert Y Leung, MD
Role: PRINCIPAL_INVESTIGATOR
San Diego Veterans Healthcare System
Locations
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VA San Diego Healthcare System
San Diego, California, United States
Countries
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Central Contacts
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Facility Contacts
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Albert Y Leung, MD
Role: backup
Other Identifiers
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W81XWH2110831
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
H210076
Identifier Type: OTHER
Identifier Source: secondary_id
CP200229
Identifier Type: -
Identifier Source: org_study_id
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