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New treatment option for Brain Concussion
Official title Repetitive Transcranial Magnetic Stimulation for Post-concussion Headaches
ClinicalTrials.gov ID: NCT06112093
What this study is testing
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 55. Healthy volunteers may be eligible.
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility criteria
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Syracuse, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 55 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Syracuse, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.