Repetitive Transcranial Magnetic Stimulation for Post-concussion Headaches

Headache Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06112093
• Other study ID #: 1825424
• Status: Recruiting
• Phase: N/A
• Start date: October 23, 2023
• Est. completion date: October 23, 2027

Study information

• Verified date: December 2023
• Source: State University of New York - Upstate Medical University
• Contact: Yi-Ling Kuo, PT, PhD
• Phone: 3154646911
• Email: kuoy[@]upstate.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: October 23, 2027
• Est. primary completion date: October 23, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• 18 - 55 years old who were actively working prior to mTBI
• first-ever 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 by a board-certified physician with subspecialty certification in Brain Injury Medicine
• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Brain Concussion
• Brain Injuries
• Brain Injuries, Traumatic
• Headache
• Mild Traumatic Brain Injury
• Post-Concussion Symptoms
• Post-Concussion Syndrome

Intervention

Device:
• Repetitive Transcranial Magnetic Stimulation
rTMS will be used to regulate the motor cortex to reduce headaches and post-concussion symptoms.
• Sham Repetitive 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.

Locations

Country	Name	City	State
United States	SUNY Upstate Medical University	Syracuse	New York

Sponsors (1)

Lead Sponsor	Collaborator
State University of New York - Upstate Medical University

Country where clinical trial is conducted

United States, 

References & Publications (21)

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Kuo YL, Kutch JJ, Fisher BE. Relationship between Interhemispheric Inhibition and Dexterous Hand Performance in Musicians and Non-musicians. Sci Rep. 2019 Aug 9;9(1):11574. doi: 10.1038/s41598-019-47959-y. — View Citation

Kuo YL, Lin DJ, Vora I, DiCarlo JA, Edwards DJ, Kimberley TJ. Transcranial magnetic stimulation to assess motor neurophysiology after acute stroke in the United States: Feasibility, lessons learned, and values for future research. Brain Stimul. 2022 Jan-Feb;15(1):179-181. doi: 10.1016/j.brs.2021.12.001. Epub 2021 Dec 7. No abstract available. — View Citation

Lefaucheur JP, Aleman A, Baeken C, Benninger DH, Brunelin J, Di Lazzaro V, Filipovic SR, Grefkes C, Hasan A, Hummel FC, Jaaskelainen SK, Langguth B, Leocani L, Londero A, Nardone R, Nguyen JP, Nyffeler T, Oliveira-Maia AJ, Oliviero A, Padberg F, Palm U, Paulus W, Poulet E, Quartarone A, Rachid F, Rektorova I, Rossi S, Sahlsten H, Schecklmann M, Szekely D, Ziemann U. Evidence-based guidelines on the therapeutic use of repetitive transcranial magnetic stimulation (rTMS): An update (2014-2018). Clin Neurophysiol. 2020 Feb;131(2):474-528. doi: 10.1016/j.clinph.2019.11.002. Epub 2020 Jan 1. Erratum In: Clin Neurophysiol. 2020 May;131(5):1168-1169. — View Citation

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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. — View Citation

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* Note: There are 21 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Daily headache diary - intensity	Headaches will be documented by a daily headache diary during rTMS intervention about the intensity (by numerical rating scale).	daily documentation throughout the treatment course (4 weeks)
Primary	Daily headache diary - frequency	Headaches will be documented by a daily headache diary during rTMS intervention about the frequency (by episode).	daily documentation throughout the treatment course (4 weeks)
Primary	Daily headache diary - duration	Headaches will be documented by a daily headache diary during rTMS intervention about the duration (by hour).	daily documentation throughout the treatment course (4 weeks)
Primary	Patient-Reported Outcomes Measurement Information System (PROMIS)	The PROMIS questionnaires with subsections of 1) pain interference, 2) pain behavior, 3) sleep disturbance, 4) sleep-related impairment 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.	baseline, immediately post-treatment (completion of rTMS), 1-month follow-up, 3-month follow-up
Primary	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.	baseline, immediately post-treatment (completion of rTMS), 1-month follow-up, 3-month follow-up
Primary	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.	baseline, immediately post-treatment (completion of rTMS), 1-month follow-up, 3-month follow-up
Primary	Rivermead Post-Concussion Symptoms Questionnaire (RPQ)	The change in global post-concussion symptoms will be measured by the RPQ. On a scale of 0 to 4, higher numbers indicate worse outcomes.	baseline, immediately post-treatment (completion of rTMS), 1-month follow-up, 3-month follow-up
Primary	Wrist actigraphy - sleep quality	Kinematic assessments by the wrist actigraphy will be worn to measure sleep quality.	baseline, immediately post-treatment (completion of rTMS)
Primary	Wrist actigraphy - physical activity level	Kinematic assessments by the wrist actigraphy will be worn to measure physical activity level.	baseline, immediately post-treatment (completion of rTMS)
Primary	Neurophysiological measures by TMS	Neurophysiology will be measured by TMS to indicate changes in brain function.	baseline, immediately post-treatment (completion of rTMS)
Primary	Gene expression	Peripheral blood will be collected to measure mRNA to impute gene expression.	baseline, immediately post-treatment (completion of rTMS)
Secondary	Length of rehabilitation (LOR)	LOR will be recorded by reviewing the medical chart.	3-month follow-up
Secondary	Return to work (RTW)	RTW will be will be calculated as the percent of time working relative to the pre-mTBI workload.	3-month follow-up