Depression Clinical Trial
Official title:
Combined Nonpharmacological Therapies for MTBI-Related Headaches
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.
Status | Recruiting |
Enrollment | 240 |
Est. completion date | August 31, 2025 |
Est. primary completion date | August 31, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | VA San Diego Healthcare System | San Diego | California |
Lead Sponsor | Collaborator |
---|---|
Veterans Medical Research Foundation |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Intensity of Persistent Headaches | Assesses the intensity of persistent headaches, from a scale of 0, being no pain, to 10, being worst possible pain. | Change from baseline to 2-, 4-, 6-, 8-, 12-, 16-, and 20-weeks follow up visit | |
Primary | Intensity of Debilitating Headaches | Assesses the intensity of debilitating headaches, from a scale of 0, being no pain, to 10, being worst possible pain. | Change from baseline to 2-, 4-, 6-, 8-, 12-, 16-, and 20-weeks follow up visit | |
Primary | Persistent Headache Frequency | Assesses the frequency per week of persistent headaches | Change from baseline to 2-, 4-, 6-, 8-, 12-, 16-, and 20-weeks follow up visit | |
Primary | Debilitating Headache Frequency | Assesses the frequency per week of debilitating headaches | Change from baseline to 2-, 4-, 6-, 8-, 12-, 16-, and 20-weeks follow up visit | |
Primary | Debilitating Headache Interference | Assesses the interference of debilitating headaches for activities of daily living, from 0, being no interference, to 10, being worst possible interference. | Change from baseline to 2-, 4-, 6-, 8-, 12-, 16-, and 20-weeks follow up visit | |
Secondary | Headache Impact Test | 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. | Change from baseline to 2-, 4-, 6-, 8-, 12-, 16-, and 20-weeks follow up visit | |
Secondary | Neurobehavioral Symptom Inventory | 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. | Change from baseline to 2-, 4-, 6-, 8-, 12-, 16-, and 20-weeks follow up visit | |
Secondary | Hamilton Rating Scale for Depression | 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. | Change from baseline to 2-, 4-, 6-, 8-, 12-, 16-, and 20-weeks follow up visit | |
Secondary | Rivermead Post-Concussion Symptoms Questionnaire | 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. | Change from baseline to 2-, 4-, 6-, 8-, 12-, 16-, and 20-weeks follow up visit | |
Secondary | Short Form Health Survey-36 | 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. | Change from baseline to 2-, 4-, 6-, 8-, 12-, 16-, and 20-weeks follow up visit | |
Secondary | Short-Form NEURO-QoL | Assesses quality of life related to neurological disorders. Each item ranges from 1-5, with a higher score indicating a worse outcome. | Change from baseline to 2-, 4-, 6-, 8-, 12-, 16-, and 20-weeks follow up visit |
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