Brain ConcussionPhase 1NCT06112093

Repetitive Transcranial Magnetic Stimulation for Post-concussion Headaches

A Phase 1 study testing Repetitive Transcranial Magnetic Stimulation in people with Brain Concussion and Mild Traumatic Brain Injury, run by State University of New York - Upstate Medical University at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Brain Concussion, Mild Traumatic Brain Injury, Headache
What is being tested?: Repetitive Transcranial Magnetic Stimulation
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 60 participants
Where: 1 siteUnited States
Study dates: 23 Oct 2023to 23 Oct 2027
Phase: Phase 1
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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
headache persists for >=3 months after head trauma despite receiving standard care
average persistent headache intensity is >= 3/10 of the numerical rating scale (NRS) on >=3days/week
no evidence of radiculopathy or peripheral neuropathy on electromyography or clinical evaluation
no evidence of other possible causes of headaches

Who cannot join

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 locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Yi-Ling Kuo, PT, PhD contact

3154646911

kuoy@upstate.edu

United States1 site, 1 recruiting

SUNY Upstate Medical University
Syracuse, New York, 13210
Yi-Ling Kuo, PT, PhD, 3154646911, kuoy@upstate.edu
Recruiting

Other trials in United States

About this study

Official title: Using Repetitive Transcranial Magnetic Stimulation to Manage Headaches and Improve Rehabilitation Outcomes in Mild Traumatic Brain Injury: A Longitudinal Study

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.

Conditions: Brain Concussion, Mild Traumatic Brain Injury, Headache, Post-Concussion Symptoms
Being tested: Repetitive Transcranial Magnetic Stimulation, Sham Repetitive Transcranial Magnetic Stimulation
Keywords: Repetitive transcranial magnetic stimulation, Non-invasive brain stimulation, Neuromodulation, Chronic pain, Biomarkers
Medical subject headings: Brain Concussion, Headache, Post-Concussion Syndrome, Chronic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Repetitive Transcranial Magnetic StimulationDevice
Also called Transcranial magnetic stimulation
rTMS will be used to regulate the motor cortex to reduce headaches and post-concussion symptoms.
Sham Repetitive Transcranial Magnetic StimulationDevice
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.

Study groups in NCT06112093
Study group	Role	What they receive
Moderate-dose rTMS	Active comparator	12 sessions (1 session/day, 3 days/week for 4 weeks) of active rTMS Receives: Device: Repetitive Transcranial Magnetic Stimulation
Sham rTMS	Sham comparator	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. Receives: Device: Sham Repetitive Transcranial Magnetic Stimulation
High-dose rTMS	Active comparator	24 sessions (4 sessions/day, 3 days/week for 2 weeks) of active rTMS Receives: Device: Repetitive Transcranial Magnetic Stimulation
Low-dose rTMS	Active comparator	6 sessions (1 session/day, 3 days/week for 2 weeks) of active rTMS Receives: Device: Repetitive Transcranial Magnetic Stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

Daily headache diary
Composite headache score will be calculated as average intensity (NRS) × average frequency (episode/day) × average duration (hours/episode).
Measured: 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.
Measured: 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
Measured: baseline, immediately post-treatment (completion of rTMS)
Neurophysiological measures by TMS
Neurophysiology will be measured by TMS to indicate changes in brain function.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: baseline, immediately post-treatment (completion of rTMS)
Gene expression
Peripheral blood will be collected to measure mRNA to impute gene expression.
Measured: 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.
Measured: baseline, immediately post-treatment (completion of rTMS)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 Oct 202323 Oct 2027

First posted1 Nov 2023
Study start23 Oct 2023
Primary completion23 Oct 2026 (estimated)
Study completion23 Oct 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (21)Papers the sponsor has linked to this study.
Other trials for Brain ConcussionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 60 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06112093
Sponsor's protocol ID: 1825424
Status last verified: Oct 2025
First submitted: 23 Oct 2023
Last updated: 10 Oct 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: 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.

Publications

Iverson GL, Gardner AJ, Terry DP, Ponsford JL, Sills AK, Broshek DK, Solomon GS. Predictors of clinical recovery from concussion: a systematic review. Br J Sports Med. 2017 Jun;51(12):941-948. doi: 10.1136/bjsports-2017-097729.
PubMed 28566342
De Kruijk JR, Leffers P, Menheere PP, Meerhoff S, Rutten J, Twijnstra A. Prediction of post-traumatic complaints after mild traumatic brain injury: early symptoms and biochemical markers. J Neurol Neurosurg Psychiatry. 2002 Dec;73(6):727-32. doi: 10.1136/jnnp.73.6.727.
PubMed 12438478
Minen MT, Boubour A, Walia H, Barr W. Post-Concussive Syndrome: a Focus on Post-Traumatic Headache and Related Cognitive, Psychiatric, and Sleep Issues. Curr Neurol Neurosci Rep. 2016 Nov;16(11):100. doi: 10.1007/s11910-016-0697-7.
PubMed 27709555
Bomyea J, Lang AJ, Delano-Wood L, Jak A, Hanson KL, Sorg S, Clark AL, Schiehser DM. Neuropsychiatric Predictors of Post-Injury Headache After Mild-Moderate Traumatic Brain Injury in Veterans. Headache. 2016 Apr;56(4):699-710. doi: 10.1111/head.12799. Epub 2016 Mar 29.
PubMed 27028095
Howard L, Schwedt TJ. Posttraumatic headache: recent progress. Curr Opin Neurol. 2020 Jun;33(3):316-322. doi: 10.1097/WCO.0000000000000815.
PubMed 32304441
Rossini PM, Burke D, Chen R, Cohen LG, Daskalakis Z, Di Iorio R, Di Lazzaro V, Ferreri F, Fitzgerald PB, George MS, Hallett M, Lefaucheur JP, Langguth B, Matsumoto H, Miniussi C, Nitsche MA, Pascual-Leone A, Paulus W, Rossi S, Rothwell JC, Siebner HR, Ugawa Y, Walsh V, Ziemann U. Non-invasive electrical and magnetic stimulation of the brain, spinal cord, roots and peripheral nerves: Basic principles and procedures for routine clinical and research application. An updated report from an I.F.C.N. Committee. Clin Neurophysiol. 2015 Jun;126(6):1071-1107. doi: 10.1016/j.clinph.2015.02.001. Epub 2015 Feb 10.
PubMed 25797650
Rossi S, Antal A, Bestmann S, Bikson M, Brewer C, Brockmoller J, Carpenter LL, Cincotta M, Chen R, Daskalakis JD, Di Lazzaro V, Fox MD, George MS, Gilbert D, Kimiskidis VK, Koch G, Ilmoniemi RJ, Lefaucheur JP, Leocani L, Lisanby SH, Miniussi C, Padberg F, Pascual-Leone A, Paulus W, Peterchev AV, Quartarone A, Rotenberg A, Rothwell J, Rossini PM, Santarnecchi E, Shafi MM, Siebner HR, Ugawa Y, Wassermann EM, Zangen A, Ziemann U, Hallett M; basis of this article began with a Consensus Statement from the IFCN Workshop on "Present, Future of TMS: Safety, Ethical Guidelines", Siena, October 17-20, 2018, updating through April 2020. Safety and recommendations for TMS use in healthy subjects and patient populations, with updates on training, ethical and regulatory issues: Expert Guidelines. Clin Neurophysiol. 2021 Jan;132(1):269-306. doi: 10.1016/j.clinph.2020.10.003. Epub 2020 Oct 24.
PubMed 33243615
Major BP, Rogers MA, Pearce AJ. Using transcranial magnetic stimulation to quantify electrophysiological changes following concussive brain injury: a systematic review. Clin Exp Pharmacol Physiol. 2015 Apr;42(4):394-405. doi: 10.1111/1440-1681.12363.
PubMed 25603731
Leung A, Shukla S, Fallah A, Song D, Lin L, Golshan S, Tsai A, Jak A, Polston G, Lee R. Repetitive Transcranial Magnetic Stimulation in Managing Mild Traumatic Brain Injury-Related Headaches. Neuromodulation. 2016 Feb;19(2):133-41. doi: 10.1111/ner.12364. Epub 2015 Nov 10.
PubMed 26555886
Leung A, Fallah A, Shukla S, Lin L, Tsia A, Song D, Polston G, Lee R. rTMS in Alleviating Mild TBI Related Headaches--A Case Series. Pain Physician. 2016 Feb;19(2):E347-54.
PubMed 26815263
Choi GS, Kwak SG, Lee HD, Chang MC. Effect of high-frequency repetitive transcranial magnetic stimulation on chronic central pain after mild traumatic brain injury: A pilot study. J Rehabil Med. 2018 Feb 28;50(3):246-252. doi: 10.2340/16501977-2321.
PubMed 29392332
Hess JL, Tylee DS, Barve R, de Jong S, Ophoff RA, Kumarasinghe N, Tooney P, Schall U, Gardiner E, Beveridge NJ, Scott RJ, Yasawardene S, Perera A, Mendis J, Carr V, Kelly B, Cairns M; Neurobehavioural Genetics Unit; Tsuang MT, Glatt SJ. Transcriptome-wide mega-analyses reveal joint dysregulation of immunologic genes and transcription regulators in brain and blood in schizophrenia. Schizophr Res. 2016 Oct;176(2-3):114-124. doi: 10.1016/j.schres.2016.07.006. Epub 2016 Jul 20.
PubMed 27450777
Hiskens MI, Schneiders AG, Angoa-Perez M, Vella RK, Fenning AS. Blood biomarkers for assessment of mild traumatic brain injury and chronic traumatic encephalopathy. Biomarkers. 2020 May;25(3):213-227. doi: 10.1080/1354750X.2020.1735521. Epub 2020 Mar 12.
PubMed 32096416
Glatt SJ, Tsuang MT, Winn M, Chandler SD, Collins M, Lopez L, Weinfeld M, Carter C, Schork N, Pierce K, Courchesne E. Blood-based gene expression signatures of infants and toddlers with autism. J Am Acad Child Adolesc Psychiatry. 2012 Sep;51(9):934-44.e2. doi: 10.1016/j.jaac.2012.07.007. Epub 2012 Aug 2.
PubMed 22917206
Hess JL, Quinn TP, Zhang C, Hearn GC, Chen S; Neuropsychiatric Consortium for Analysis and Sharing of Transcriptomes; Kong SW, Cairns M, Tsuang MT, Faraone SV, Glatt SJ. BrainGENIE: The Brain Gene Expression and Network Imputation Engine. Transl Psychiatry. 2023 Mar 22;13(1):98. doi: 10.1038/s41398-023-02390-w.
PubMed 36949060

Interested in taking part?

Yi-Ling Kuo, PT, PhD

3154646911

kuoy@upstate.edu

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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Rehabilitation Through Virtual Immersion & Integrated Exposure for Mild Traumatic Brain Injury (ReVIVE for mTBI)
Traumatic Brain Injuries, TBI (Traumatic Brain Injury)
Not yet recruiting
Electroencephalography Markers of Brain Stimulation in Post-Concussion Patients
Patients With Persistent Post-concussion Symptoms
Not yet recruitingObservational study
Cognitive Effects of Hyperbaric Oxygen Therapy (HBOT) After a Traumatic Brain Injury
Traumatic Brain Injury, Post-Concussion Syndrome
Recruiting
Percutaneous Electrical Nerve Field Stimulation (PENFS) in Patients With Post Concussion Syndrome (PCS)
Post-Concussion Syndrome, COVID Long-Haul
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Sleep MAPP in the Polytrauma/TBI System of Care
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All Brain Concussion trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Using Repetitive Transcranial Magnetic Stimulation to Manage Headaches and Improve Rehabilitation Outcomes in Mild Traumatic Brain Injury: A Longitudinal Study
ClinicalTrials.gov ID: NCT06112093
Acronym / sponsor ID: 1825424
Conditions: Brain Concussion, Mild Traumatic Brain Injury, Headache, Post-Concussion Symptoms
Keywords: Repetitive transcranial magnetic stimulation, Non-invasive brain stimulation, Neuromodulation, Chronic pain, Biomarkers
Phase: Phase 1
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 60 participants (estimated)
Lead sponsor: State University of New York - Upstate Medical UniversityUniversity, hospital or other
Study start: 23 Oct 2023 (actual)
Primary completion: 23 Oct 2026 (estimated)
Study completion: 23 Oct 2027 (estimated)
First posted: 1 Nov 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Moderate-dose rTMS	Active comparator	Device: Repetitive Transcranial Magnetic Stimulation12 sessions (1 session/day, 3 days/week for 4 weeks) of active rTMS
Sham rTMS	Sham comparator	Device: Sham Repetitive Transcranial Magnetic Stimulation12 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.
High-dose rTMS	Active comparator	Device: Repetitive Transcranial Magnetic Stimulation24 sessions (4 sessions/day, 3 days/week for 2 weeks) of active rTMS
Low-dose rTMS	Active comparator	Device: Repetitive Transcranial Magnetic Stimulation6 sessions (1 session/day, 3 days/week for 2 weeks) of active rTMS

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (8 listed)

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
headache persists for >=3 months after head trauma despite receiving standard care

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Repetitive Transcranial Magnetic StimulationAlso: Transcranial magnetic stimulationrTMS will be used to regulate the motor cortex to reduce headaches and post-concussion symptoms.	Device	High-dose rTMS, Low-dose rTMS, Moderate-dose rTMS
Sham Repetitive Transcranial Magnetic StimulationSham 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.	Device	Sham rTMS

Primary outcome

Daily headache diary
Time frame: daily documentation throughout the treatment course (4 weeks)
Composite headache score will be calculated as average intensity (NRS) × average frequency (episode/day) × average duration (hours/episode).
Patient-Reported Outcomes Measurement Information System (PROMIS)
Time frame: baseline, immediately post-treatment (completion of rTMS), 1-month follow-up, 3-month follow-up, 6-month follow-up
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.
Protein expression
Time frame: baseline, immediately post-treatment (completion of rTMS)
Peripheral blood will be collected to measure protein expression
Neurophysiological measures by TMS
Time frame: baseline, immediately post-treatment (completion of rTMS)
Neurophysiology will be measured by TMS to indicate changes in brain function.
Headache impact test 6 (HIT-6)
Time frame: baseline, immediately post-treatment (completion of rTMS), 1-month follow-up, 3-month follow-up, 6-month follow-up
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.
Post-Concussion Symptom Scale (PCSS)
Time frame: baseline, immediately post-treatment (completion of rTMS), 1-month follow-up, 3-month follow-up, 6-month follow-up
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.
Wrist actigraphy - physical activity level
Time frame: baseline, immediately post-treatment (completion of rTMS)
Kinematic assessments by the wrist actigraphy will be worn to measure physical activity level.
Gene expression
Time frame: baseline, immediately post-treatment (completion of rTMS)
Peripheral blood will be collected to measure mRNA to impute gene expression.

1 secondary outcome

Wrist actigraphy - sleep quality
Time frame: baseline, immediately post-treatment (completion of rTMS)

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2025.
Background: PubMed 28566342Iverson GL, Gardner AJ, Terry DP, Ponsford JL, Sills AK, Broshek DK, Solomon GS. Predictors of clinical recovery from concussion: a systematic review. Br J Sports Med. 2017 Jun;51(12):941-948. doi: 10.1136/bjsports-2017-097729.
Background: PubMed 12438478De Kruijk JR, Leffers P, Menheere PP, Meerhoff S, Rutten J, Twijnstra A. Prediction of post-traumatic complaints after mild traumatic brain injury: early symptoms and biochemical markers. J Neurol Neurosurg Psychiatry. 2002 Dec;73(6):727-32. doi: 10.1136/jnnp.73.6.727.
Background: PubMed 27709555Minen MT, Boubour A, Walia H, Barr W. Post-Concussive Syndrome: a Focus on Post-Traumatic Headache and Related Cognitive, Psychiatric, and Sleep Issues. Curr Neurol Neurosci Rep. 2016 Nov;16(11):100. doi: 10.1007/s11910-016-0697-7.
Background: PubMed 27028095Bomyea J, Lang AJ, Delano-Wood L, Jak A, Hanson KL, Sorg S, Clark AL, Schiehser DM. Neuropsychiatric Predictors of Post-Injury Headache After Mild-Moderate Traumatic Brain Injury in Veterans. Headache. 2016 Apr;56(4):699-710. doi: 10.1111/head.12799. Epub 2016 Mar 29.
Background: PubMed 32304441Howard L, Schwedt TJ. Posttraumatic headache: recent progress. Curr Opin Neurol. 2020 Jun;33(3):316-322. doi: 10.1097/WCO.0000000000000815.
Background: PubMed 25797650Rossini PM, Burke D, Chen R, Cohen LG, Daskalakis Z, Di Iorio R, Di Lazzaro V, Ferreri F, Fitzgerald PB, George MS, Hallett M, Lefaucheur JP, Langguth B, Matsumoto H, Miniussi C, Nitsche MA, Pascual-Leone A, Paulus W, Rossi S, Rothwell JC, Siebner HR, Ugawa Y, Walsh V, Ziemann U. Non-invasive electrical and magnetic stimulation of the brain, spinal cord, roots and peripheral nerves: Basic principles and procedures for routine clinical and research application. An updated report from an I.F.C.N. Committee. Clin Neurophysiol. 2015 Jun;126(6):1071-1107. doi: 10.1016/j.clinph.2015.02.001. Epub 2015 Feb 10.
Background: PubMed 33243615Rossi S, Antal A, Bestmann S, Bikson M, Brewer C, Brockmoller J, Carpenter LL, Cincotta M, Chen R, Daskalakis JD, Di Lazzaro V, Fox MD, George MS, Gilbert D, Kimiskidis VK, Koch G, Ilmoniemi RJ, Lefaucheur JP, Leocani L, Lisanby SH, Miniussi C, Padberg F, Pascual-Leone A, Paulus W, Peterchev AV, Quartarone A, Rotenberg A, Rothwell J, Rossini PM, Santarnecchi E, Shafi MM, Siebner HR, Ugawa Y, Wassermann EM, Zangen A, Ziemann U, Hallett M; basis of this article began with a Consensus Statement from the IFCN Workshop on "Present, Future of TMS: Safety, Ethical Guidelines", Siena, October 17-20, 2018, updating through April 2020. Safety and recommendations for TMS use in healthy subjects and patient populations, with updates on training, ethical and regulatory issues: Expert Guidelines. Clin Neurophysiol. 2021 Jan;132(1):269-306. doi: 10.1016/j.clinph.2020.10.003. Epub 2020 Oct 24.
Background: PubMed 25603731Major BP, Rogers MA, Pearce AJ. Using transcranial magnetic stimulation to quantify electrophysiological changes following concussive brain injury: a systematic review. Clin Exp Pharmacol Physiol. 2015 Apr;42(4):394-405. doi: 10.1111/1440-1681.12363.
Background: PubMed 26555886Leung A, Shukla S, Fallah A, Song D, Lin L, Golshan S, Tsai A, Jak A, Polston G, Lee R. Repetitive Transcranial Magnetic Stimulation in Managing Mild Traumatic Brain Injury-Related Headaches. Neuromodulation. 2016 Feb;19(2):133-41. doi: 10.1111/ner.12364. Epub 2015 Nov 10.
Background: PubMed 26815263Leung A, Fallah A, Shukla S, Lin L, Tsia A, Song D, Polston G, Lee R. rTMS in Alleviating Mild TBI Related Headaches--A Case Series. Pain Physician. 2016 Feb;19(2):E347-54.
Background: PubMed 29392332Choi GS, Kwak SG, Lee HD, Chang MC. Effect of high-frequency repetitive transcranial magnetic stimulation on chronic central pain after mild traumatic brain injury: A pilot study. J Rehabil Med. 2018 Feb 28;50(3):246-252. doi: 10.2340/16501977-2321.
Background: PubMed 27450777Hess JL, Tylee DS, Barve R, de Jong S, Ophoff RA, Kumarasinghe N, Tooney P, Schall U, Gardiner E, Beveridge NJ, Scott RJ, Yasawardene S, Perera A, Mendis J, Carr V, Kelly B, Cairns M; Neurobehavioural Genetics Unit; Tsuang MT, Glatt SJ. Transcriptome-wide mega-analyses reveal joint dysregulation of immunologic genes and transcription regulators in brain and blood in schizophrenia. Schizophr Res. 2016 Oct;176(2-3):114-124. doi: 10.1016/j.schres.2016.07.006. Epub 2016 Jul 20.
Individual participant dataSharing planned: 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.

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Electroencephalography Markers of Brain Stimulation in Post-Concussion Patients
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Yi-Ling Kuo, PT, PhD contact

3154646911

kuoy@upstate.edu

Yi-Ling Kuo, PT, PhD principal investigator

State University of New York - Upstate Medical University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 10 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Yi-Ling Kuo, PT, PhD (3154646911, kuoy@upstate.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Daily headache diary (time frame: daily documentation throughout the treatment course (4 weeks)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06112093, which also lists 21 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2025.