Accelerated, Theta-burst Stimulation for the Treatment of Post-concussion Syndrome

Launched by SUNNYBROOK HEALTH SCIENCES CENTRE · Sep 7, 2023

Keywords

ClinConnect Summary

The clinical trial titled "Accelerated, Theta-burst Stimulation for the Treatment of Post-concussion Syndrome" is exploring a new treatment option for individuals suffering from post-concussion syndrome (PCS). PCS can occur after a head injury and may lead to symptoms like headaches, dizziness, fatigue, and memory problems. This trial is testing a specific type of brain stimulation called intermittent theta-burst stimulation (iTBS), which is delivered quickly and is designed to help improve brain function. Participants in the study will receive this treatment over the course of one week, which is much shorter than traditional methods that typically take six weeks.

To be eligible for the trial, participants should be between 18 and 60 years old and have experienced PCS symptoms for at least three months but less than a year following a head injury. They should also show evidence of the head trauma and have at least three PCS symptoms. However, individuals with certain medical conditions, such as severe brain injuries or specific psychiatric disorders, may not qualify. Those who join the study can expect to receive a series of safe and non-invasive brain stimulation sessions, with the added benefit of being guided by advanced MRI technology to target the treatment more precisely. This trial aims to find out if this faster method of stimulation can effectively help those struggling with the effects of concussions.

Gender

ALL

Eligibility 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