An interventional study of Active rTMS and Headache Management Therapy in TBI (Traumatic Brain Injury), Headache and Depression, sponsored by Veterans Medical Research Foundation. Recruiting at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-11-21.
Sponsored by Veterans Medical Research Foundation · Not applicable, Interventional, and Treatment
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.
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:
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.
2,113 studies on the registry are indexed under Brain Injuries; 385 are open to participants now.
This study's planned enrollment of 240 is above the median of 48 across 1,331 interventional studies indexed under Brain Injuries.
Browse Brain Injuries studies →Veterans Medical Research Foundation is the lead sponsor of 43 studies on the registry; 9 are open to participants now.
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Exclusion Criteria:
Participants receive both active rTMS treatment at the left dorsolateral prefrontal cortex and therapy for headache management
Device: Active rTMS · Behavioral: Headache Management Therapy
Participants receive active rTMS treatment at the left dorsolateral prefrontal cortex and headache education
Device: Active rTMS · Behavioral: Headache Education Control
Participants receive sham rTMS treatment at the left dorsolateral prefrontal cortex and therapy for headache management
Behavioral: Headache Management Therapy · Device: Sham rTMS
Participants receive sham rTMS treatment at the left dorsolateral prefrontal cortex and headache education
Device: Sham rTMS · Behavioral: Headache Education Control
Active rTMS will be given at the left dorsolateral prefrontal cortex with a double blind TMS coil.
Therapy will be provided on headache management.
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.
In the control, educational sessions on headaches will be provided.
Intensity of Persistent Headaches
Assesses the intensity of persistent headaches, from a scale of 0, being no pain, to 10, being worst possible pain.
Time frame: Change from baseline to 2-, 4-, 6-, 8-, 12-, 16-, and 20-weeks follow up visit
Intensity of Debilitating Headaches
Assesses the intensity of debilitating headaches, from a scale of 0, being no pain, to 10, being worst possible pain.
Time frame: Change from baseline to 2-, 4-, 6-, 8-, 12-, 16-, and 20-weeks follow up visit
Persistent Headache Frequency
Assesses the frequency per week of persistent headaches
Time frame: Change from baseline to 2-, 4-, 6-, 8-, 12-, 16-, and 20-weeks follow up visit
Debilitating Headache Frequency
Assesses the frequency per week of debilitating headaches
Time frame: Change from baseline to 2-, 4-, 6-, 8-, 12-, 16-, and 20-weeks follow up visit
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.
Time frame: Change from baseline to 2-, 4-, 6-, 8-, 12-, 16-, and 20-weeks follow up visit
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.
Time frame: Change from baseline to 2-, 4-, 6-, 8-, 12-, 16-, and 20-weeks follow up visit
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.
Time frame: Change from baseline to 2-, 4-, 6-, 8-, 12-, 16-, and 20-weeks follow up visit
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.
Time frame: Change from baseline to 2-, 4-, 6-, 8-, 12-, 16-, and 20-weeks follow up visit
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.
Time frame: Change from baseline to 2-, 4-, 6-, 8-, 12-, 16-, and 20-weeks follow up visit
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.
Time frame: Change from baseline to 2-, 4-, 6-, 8-, 12-, 16-, and 20-weeks follow up visit
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.
Time frame: Change from baseline to 2-, 4-, 6-, 8-, 12-, 16-, and 20-weeks follow up visit
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