RECRUITING

Repetitive Transcranial Magnetic Stimulation for Post-concussion Headaches

Conditions

Brain Concussion Mild Traumatic Brain Injury Headache Post-Concussion Symptoms Repetitive transcranial magnetic stimulation Non-invasive brain stimulation Neuromodulation Chronic pain Biomarkers

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-10-23

Study Completion:2027-10-23

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06112093

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 55 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
* 18 - 55 years old who were actively working prior to mTBI * 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	* 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

Inclusion Criteria

Exclusion Criteria

* 18 - 55 years old who were actively working prior to mTBI
* 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

* 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

Contacts and Locations

Study Contact

Yi-Ling Kuo, PT, PhD

CONTACT

3154646911

kuoy@upstate.edu

Principal Investigator

Yi-Ling Kuo, PT, PhD

PRINCIPAL_INVESTIGATOR

State University of New York - Upstate Medical University

Study Locations (Sites)

SUNY Upstate Medical University

Syracuse, New York, 13210

United States

Collaborators and Investigators

Sponsor: State University of New York - Upstate Medical University

Yi-Ling Kuo, PT, PhD, PRINCIPAL_INVESTIGATOR, State University of New York - Upstate Medical University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-10-23

Study Completion Date2027-10-23

Study Record Updates

Study Start Date2023-10-23

Study Completion Date2027-10-23

Terms related to this study

Keywords Provided by Researchers

Repetitive transcranial magnetic stimulation
Non-invasive brain stimulation
Neuromodulation
Chronic pain
Biomarkers

Additional Relevant MeSH Terms

Brain Concussion
Mild Traumatic Brain Injury
Headache
Post-Concussion Symptoms