Depression, Headache, TBI (Traumatic Brain Injury)
Conditions
Keywords
rTMS, transcranial magnetic stimulation, therapy
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.
Interventions
DEVICEActive rTMS
Active rTMS will be given at the left dorsolateral prefrontal cortex with a double blind TMS coil.
BEHAVIORALHeadache Management Therapy
Therapy will be provided on headache management.
DEVICESham 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.
BEHAVIORALHeadache Education Control
In the control, educational sessions on headaches will be provided.
Sponsors
Veterans Medical Research Foundation
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
The participant, study coordinators and the investigators will be blinded to the rTMS treatment. The participant will be blinded to the therapy group (headache management or headache education).
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Debilitating Headache Interference | Change from baseline to 2-, 4-, 6-, 8-, 12-, 16-, and 20-weeks follow up visit | Assesses the interference of debilitating headaches for activities of daily living, from 0, being no interference, to 10, being worst possible interference. |
| Intensity of Persistent Headaches | Change from baseline to 2-, 4-, 6-, 8-, 12-, 16-, and 20-weeks follow up visit | Assesses the intensity of persistent headaches, from a scale of 0, being no pain, to 10, being worst possible pain. |
| Intensity of Debilitating Headaches | Change from baseline to 2-, 4-, 6-, 8-, 12-, 16-, and 20-weeks follow up visit | Assesses the intensity of debilitating headaches, from a scale of 0, being no pain, to 10, being worst possible pain. |
| Persistent Headache Frequency | Change from baseline to 2-, 4-, 6-, 8-, 12-, 16-, and 20-weeks follow up visit | Assesses the frequency per week of persistent headaches |
| Debilitating Headache Frequency | Change from baseline to 2-, 4-, 6-, 8-, 12-, 16-, and 20-weeks follow up visit | Assesses the frequency per week of debilitating headaches |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Headache Impact Test | Change from baseline to 2-, 4-, 6-, 8-, 12-, 16-, and 20-weeks follow up visit | Measures the impact of headache on an individual's ability to function at work, school, home, and/or social situations. Each item is measured from never, rarely, sometimes, very often, or always, with scores of 6, 8, 10, 11, and 13 respectively. A higher score correlates to a greater negative impact of headaches on quality of life. |
| Short-Form NEURO-QoL | Change from baseline to 2-, 4-, 6-, 8-, 12-, 16-, and 20-weeks follow up visit | Assesses quality of life related to neurological disorders. Each item ranges from 1-5, with a higher score indicating a worse outcome. |
| Neurobehavioral Symptom Inventory | Change from baseline to 2-, 4-, 6-, 8-, 12-, 16-, and 20-weeks follow up visit | Assesses the severity of symptoms in the following areas: somatic, cognitive, affective, and sensory. Each item ranges from 0-4 with a higher score indicating a worse outcome. |
| Hamilton Rating Scale for Depression | Change from baseline to 2-, 4-, 6-, 8-, 12-, 16-, and 20-weeks follow up visit | Rates the severity of symptoms observed in depression such as low mood, insomnia, agitation, anxiety and weight loss. Scores range from 0 to 53, with a higher score indicating a larger degree of depression. |
| Rivermead Post-Concussion Symptoms Questionnaire | Change from baseline to 2-, 4-, 6-, 8-, 12-, 16-, and 20-weeks follow up visit | Assesses somatic, cognitive, and emotional symptoms experiences after traumatic brain injury. Each item ranges from 0-4, with a higher score indicating a worse outcome. |
| Short Form Health Survey-36 | Change from baseline to 2-, 4-, 6-, 8-, 12-, 16-, and 20-weeks follow up visit | Measures health status and quality of life in regards to eight main areas: vitality, physical functioning, bodily pain, health perceptions, physical, emotional, and social role functioning and mental health. Each item is scored on a 0 to 100 range, with a higher score indicating a worse outcome. |
Countries
United States
Contacts
Primary ContactCaleb Lopez, BS
Outcome results
None listed