Repetitive Transcranial Magnetic Stimulation for Post-concussion Headaches
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorState University of New York - Upstate Medical University
About this trial
This study aims to examine the long-term effect of repetitive transcranial magnetic stimulation (rTMS), a non-invasive brain stimulation technique, on chronic headaches following mild traumatic brain injury (mTBI). rTMS has been shown to be effective in reducing chronic headaches without side effects commonly seen in medications, such as sleepiness and addiction. This study uses rTMS to manage chronic headaches to improve post-concussion symptoms and reduce the economic burden due to delayed recovery. This project aims to better identify biomarkers for diagnosis and prognosis and maximize recovery from mTBI.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
18 - 55 years old
mTBI with loss of consciousness for less than 30 min, initial Glasgow Coma Scale between 13 and 15, or post-traumatic amnesia for ≤ 24 hours
diagnosis of persistent post-traumatic headache according to the International Classification of Headache Disorders, 3rd edition (ICHD-3) criteria
headache develops within 7 days after head trauma
Disqualifiers
history of chronic headache diagnoses such as migraine, tension, or cluster headaches prior to the incidence of mTBI
history of other neurologic conditions with medications affecting the central nervous system
contraindications of receiving TMS (e.g., a history of epileptic seizure and having implants like a cardiac pacemaker or intracerebral vascular clip
Trial design
Design model
Parallel
Treatments tested in this trial
Repetitive Transcranial Magnetic Stimulation
DevicerTMS will be used to regulate the motor cortex to reduce headaches and post-concussion symptoms.
Sham Repetitive Transcranial Magnetic Stimulation
DeviceSham rTMS will be delivered by a sham coil as a comparator to the (active) rTMS. Sham rTMS will not change the brain function of the control group.
Treatment groups
60 Participants
are divided into 4 treatment groupsGroup A: Moderate-dose rTMSActive comparator 1 intervention
Group B: Sham rTMSSham comparator 1 intervention
Group C: High-dose rTMSActive comparator 1 intervention
Group D: Low-dose rTMSActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Daily headache diary
Composite headache score will be calculated as average intensity (NRS) × average frequency (episode/day) × average duration (hours/episode).
Time frame
daily documentation throughout the treatment course (4 weeks)2
Patient-Reported Outcomes Measurement Information System (PROMIS)
The PROMIS questionnaires with subsections of 1) pain interference, 2) pain behavior will be used as patient-reported outcomes of pain and sleep. For all subsections, on a scale of 1 to 5, higher numbers indicate worse outcomes.
Time frame
baseline, immediately post-treatment (completion of rTMS), 1-month follow-up, 3-month follow-up, 6-month follow-up3
Protein expression
Peripheral blood will be collected to measure protein expression
Time frame
baseline, immediately post-treatment (completion of rTMS)4
Neurophysiological measures by TMS
Neurophysiology will be measured by TMS to indicate changes in brain function.
Time frame
baseline, immediately post-treatment (completion of rTMS)Secondary outcomes
1
Wrist actigraphy - sleep quality
Kinematic assessments by the wrist actigraphy will be worn to measure sleep quality.
Time frame
baseline, immediately post-treatment (completion of rTMS)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov