Combined Transcranial Magnetic Stimulation and Therapy for MTBI Related Headaches
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorVeterans Medical Research Foundation
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Mild Traumatic Brain Injury (mTBI)
Chronic headaches > 3 months after injury
Aged 18-65
No prior TMS treatment
Disqualifiers
Pregnant
Pacemaker or any metal in body that would prevent MRI
History of dementia or major psychiatric disease, such as bipolar disorder or schizophrenia
Presence of any other chronic neuropathic pain states
Trial design
Design model
Factorial
Treatments tested in this trial
Active rTMS
DeviceActive rTMS will be given at the left dorsolateral prefrontal cortex with a double blind TMS coil.
Headache Management Therapy
BehavioralTherapy will be provided on headache management.
Sham rTMS
DeviceSham 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
BehavioralIn the control, educational sessions on headaches will be provided.
Treatment groups
240 Participants
are divided into 4 treatment groupsGroup A: Active rTMS with telehealth headache management therapyActive comparator 2 interventions
Group B: Active rTMS with telehealth headache education controlOther 2 interventions
Group C: Sham rTMS with telehealth headache management therapyOther 2 interventions
Group D: Sham rTMS with telehealth headache education controlSham comparator 2 interventions
Trial outcomes
Primary outcomes
1
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 visit2
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 visit3
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 visit4
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 visitSecondary outcomes
1
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 visit2
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 visit3
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 visit4
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 visitSponsors and contacts
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Source ClinicalTrials.gov