Image-guided, Accelerated, Theta-burst Stimulation for the Treatment of Post-concussion Syndrome - Open-label Pilot Study

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The current study aims to better understand the efficacy of intermittent theta-burst stimulation (iTBS) treatment in patients diagnosed with post-concussion syndrome (PCS) and to explore changes in brain networks after undergoing iTBS to assess its safety and feasibility in treating PCS.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Canada
Sunnybrook Health Sciences Centre
RECRUITING
Toronto
Contact Information
Primary
Sean M Nestor, MD
sean.nestor@sunnybrook.ca
416-480-4085
Backup
Erica S Reyvas, BA
erica.reyvas@sri.utoronto.ca
416-480-4053
Time Frame
Start Date: 2024-04-29
Estimated Completion Date: 2026-03
Participants
Target number of participants: 10
Treatments
Experimental: Accelerated Intermittent Theta-Burst Stimulation
Non-invasive brain stimulation technique, accelerated intermittent theta-burst stimulation (iTBS) repetitive transcranial magnetic stimulation (rTMS), for treating post- concussive syndrome (PCS) in persons with mild traumatic brain injury
Related Therapeutic Areas
Sponsors
Leads: Sunnybrook Health Sciences Centre

This content was sourced from clinicaltrials.gov

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