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Behavioural Intervention

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

Documented evidence of head trauma sufficiently severe to result in loss of consciousness, post-traumatic amnesia and/or acute altered mental status

Age 18-60, inclusive

Must not have

History of seizure disorder, not including febrile seizures in childhood

History of prior rTMS therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 month post-treatment

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to see if a new treatment called intermittent theta-burst stimulation (iTBS) can help patients with post-concussion syndrome (PCS). Researchers also want to see how iTBS affects

Who is the study for?

This trial is for individuals with post-concussion syndrome, which means they have lingering symptoms like headaches or dizziness after a head injury. Participants should be diagnosed with PCS to qualify.

What is being tested?

The study is testing intermittent theta-burst stimulation (iTBS), a non-invasive brain stimulation technique, to see if it can help relieve symptoms of post-concussion syndrome and improve brain function.

What are the potential side effects?

Possible side effects of iTBS may include discomfort at the stimulation site, headache, lightheadedness, or seizures in very rare cases. Most people tolerate the treatment well.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had a head injury that caused me to lose consciousness or forget things.

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I am between 18 and 60 years old.

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I experience at least three symptoms like headache, dizziness, or fatigue.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of seizures, not counting childhood febrile seizures.

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I have previously undergone rTMS therapy.

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I am currently on medication for epilepsy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 month post-treatment

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-Asberg Depression Rating Scale

Repeatable Battery for the Assessment of Neuropsychological Status

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Accelerated Intermittent Theta-Burst StimulationExperimental Treatment1 Intervention

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

0 / 6Eligibility criteria met