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Procedure

Theta-Burst Stimulation for Post-Concussion Syndrome

N/A
Recruiting
Research Sponsored by Sunnybrook Health Sciences Centre
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 month post-treatment

Summary

This trial uses TMS to treat depression. It uses a new type of stimulation that is quicker and more effective than before, and it also has the capability to use MRI images to guide the stimulation.

Who is the study for?
This trial is for adults aged 18-60 who've had a head injury leading to loss of consciousness or memory issues, with symptoms like headaches and dizziness starting within 4 weeks of the injury and lasting 3-12 months. Participants must be able to consent and follow the study plan but can't join if they have major brain damage, history of seizures (except childhood febrile seizures), are pregnant, on certain medications, or involved in personal injury lawsuits.
What is being tested?
The trial tests an advanced form of brain stimulation called intermittent Theta-Burst Stimulation (iTBS) against a sham treatment. iTBS aims to improve neural plasticity using rapid bursts mimicking natural brain patterns. It's delivered over five days instead of six weeks like older methods. The technology also allows targeting specific brain areas implicated in Post-Concussion Syndrome using MRI guidance.
What are the potential side effects?
While not explicitly listed here, typical side effects from similar treatments may include discomfort at the stimulation site, headache, lightheadedness, or temporary hearing changes due to the noise during MRI-guided sessions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 month post-treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 month post-treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Rivermead Post Concussion Symptoms Questionnaire
Secondary study objectives
Headache Impact Test
Montgomery-Åsberg Depression Rating Scale
Repeatable Battery for the Assessment of Neuropsychological Status
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: TreatmentExperimental Treatment1 Intervention
Group II: ShamPlacebo Group1 Intervention

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Who is running the clinical trial?

Sunnybrook Health Sciences CentreLead Sponsor
681 Previous Clinical Trials
1,565,732 Total Patients Enrolled
~9 spots leftby Aug 2025
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