Accelerated theta-burst stimulation for treating post-concussion syndrome
Image-guided, Accelerated, Theta-burst Stimulation for the Treatment of Post-concussion Syndrome
This study is testing a quick brain stimulation treatment to see if it can help people with post-concussion syndrome feel better by reducing symptoms like headaches and dizziness.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 26 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Sunnybrook Health Sciences Centre Academic / other |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT06031662 on ClinicalTrials.gov |
What this trial studies
This study investigates the use of intermittent theta-burst stimulation (iTBS) as a treatment for post-concussion syndrome (PCS). The approach involves delivering rapid bursts of magnetic stimulation to the brain, specifically targeting the left dorsolateral prefrontal cortex, over a series of sessions. The goal is to enhance neural plasticity and alleviate symptoms associated with PCS, such as headaches, dizziness, and mood dysregulation. The treatment is designed to be efficient, taking only about 3 minutes per session compared to traditional methods that require significantly longer.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-60 who have experienced head trauma leading to PCS symptoms lasting between 3 to 12 months.
Not a fit: Patients with major structural brain abnormalities or those who have previously undergone rTMS therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a faster and more effective option for patients suffering from post-concussion syndrome.
How similar studies have performed: Previous studies using similar theta-burst stimulation techniques have shown promising results in treating other conditions, suggesting potential for success in this application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Documented evidence of head trauma sufficiently severe to result in loss of consciousness, post-traumatic amnesia and/or acute altered mental status. * At least three symptoms including headache, dizziness, fatigue, irritability, insomnia, memory difficulties, concentration difficulties, mood dysregulation. * Onset of symptoms within 4 weeks following the head trauma. * Age 18-60, inclusive. * Persistence of PCS symptoms for at least 3 months but less than 12 months * Able to provide informed consent and comply with the study protocol * Patients will not be excluded solely on the basis of communication (i.e., non-English speaking) unless they have exclusion criteria that is the cause of the communication difficulties. Exclusion Criteria: * Evidence of major structural neuroimaging abnormalities (e.g., intracranial hemorrhage, skull fracture or a large intracranial lesion) * History of prior rTMS therapy, * Contraindications to MRI (e.g., pacemaker, metallic implants etc.). * Ferromagnetic, non-removable metallic implants from above the clavicle with the exception of dental work. * Active personal injury litigation * History of seizure disorder, not including febrile seizures in childhood * Substance dependence within the last 6 months * Pregnant * Currently taking more than lorazepam 2 mg daily (or benzodiazepine equivalent) or any dose of an anticonvulsant (due to the potential to reduce rTMS efficacy) * Currently taking an antiepileptic medication * Mild and major comorbid medical conditions (as determined by investigators - e.g., neurological diseases, uncontrolled hypertension or diabetes, malignancy) * A major comorbid psychiatric disorder (as determined by investigators - e.g., schizophrenia or bipolar disorder) and/or psychosis at the time of study enrollment
Where this trial is running
Toronto, Ontario
- Sunnybrook Health Sciences Centre — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Study coordinator: Sean Nestor, PhD, MD, FRCPC
- Email: sean.nestor@sunnybrook.ca
- Phone: 416-480-4085
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.