A Phase 1 interventional study of Repetitive Transcranial Magnetic Stimulation and Sham Repetitive Transcranial Magnetic Stimulation in Brain Concussion, Mild Traumatic Brain Injury and Headache, sponsored by State University of New York - Upstate Medical University. Recruiting at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-10-10.
Sponsored by State University of New York - Upstate Medical University · Phase 1, Interventional, and Treatment
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.
141 studies on the registry are indexed under Post-Concussion Syndrome; 34 are open to participants now.
This study's planned enrollment of 60 is above the median of 52 across 114 interventional studies indexed under Post-Concussion Syndrome.
Browse Post-Concussion Syndrome studies →State University of New York - Upstate Medical University is the lead sponsor of 157 studies on the registry; 18 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 4 (36%) have results posted.
Compared within Post-Concussion Syndrome, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Brain Concussion. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
12 sessions (1 session/day, 3 days/week for 4 weeks) of active rTMS
Device: Repetitive Transcranial Magnetic Stimulation
12 sessions (1 session/day, 3 days/week for 4 weeks) of sham rTMS will be administered at the same location and duration as the Moderate-rTMS protocol. After the study is completed, participants will be offered an opportunity to receive active rTMS.
Device: Sham Repetitive Transcranial Magnetic Stimulation
24 sessions (4 sessions/day, 3 days/week for 2 weeks) of active rTMS
Device: Repetitive Transcranial Magnetic Stimulation
6 sessions (1 session/day, 3 days/week for 2 weeks) of active rTMS
Device: Repetitive Transcranial Magnetic Stimulation
rTMS will be used to regulate the motor cortex to reduce headaches and post-concussion symptoms.
Also known as: Transcranial magnetic stimulation
Sham 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.
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)
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-up
Protein expression
Peripheral blood will be collected to measure protein expression
Time frame: baseline, immediately post-treatment (completion of rTMS)
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)
Headache impact test 6 (HIT-6)
The HIT-6 will be used to assess the impact of headaches on one's ability to function in occupational and social lives. On a scale of 36 to 78, 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-up
Post-Concussion Symptom Scale (PCSS)
The change in global post-concussion symptoms will be measured by the PCSS. 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-up
Wrist actigraphy - physical activity level
Kinematic assessments by the wrist actigraphy will be worn to measure physical activity level.
Time frame: baseline, immediately post-treatment (completion of rTMS)
Gene expression
Peripheral blood will be collected to measure mRNA to impute gene expression.
Time frame: baseline, immediately post-treatment (completion of rTMS)
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)
Plan to share: Yes — The study investigators will make the de-identified data available to users for research purposes. Sharing and modification rights of the study data will be determined for individual users by the Principal Investigator.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: Data will be available no later than upon the publication of the final dataset.
Access criteria: Study personnel on the list approved by the Institutional Review Board and researchers outside of this project as approved by the Principal Investigator
Started Oct 2023 (actual). Primary completion is estimated for Oct 2026, 36 months after the start.
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State University of New York - Upstate Medical University →