Using theta-burst stimulation to treat post-concussion syndrome
Image-guided, Accelerated, Theta-burst Stimulation for the Treatment of Post-concussion Syndrome - Open-label Pilot Study
This study is testing a new brain stimulation treatment to see if it can help people with post-concussion syndrome feel better and improve their mood and thinking.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Sunnybrook Health Sciences Centre Academic / other |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT06398665 on ClinicalTrials.gov |
What this trial studies
This open-label pilot study investigates the efficacy of accelerated intermittent theta-burst stimulation (iTBS) for treating post-concussion syndrome (PCS) in individuals with mild traumatic brain injury. The study aims to assess the safety and feasibility of this non-invasive brain stimulation technique, which may improve symptoms such as cognitive impairment and mood dysregulation. Participants will undergo iTBS treatment while their brain function is monitored using functional magnetic resonance imaging (fMRI) to evaluate changes in brain networks. The research is conducted at Sunnybrook's Harquail Centre for Neuromodulation, leveraging their expertise in brain stimulation therapies.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-60 who have experienced mild traumatic brain injury and have persistent PCS symptoms for at least 3 months but less than 24 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 new, effective option for patients suffering from post-concussion syndrome.
How similar studies have performed: Previous studies have shown promise with conventional rTMS approaches for PCS, but this specific accelerated iTBS method is relatively novel.
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 24 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 M Nestor, MD
- 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.