Individualized rehabilitation for adults with persistent concussion symptoms
Effectiveness of Targeted Individualized Multi-modal Treatments in Adults Suffering From Persistent Concussion Symptoms as Compared to Usual Care
This study is testing whether personalized rehabilitation can help adults with ongoing concussion symptoms feel better compared to those getting standard care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | University Health Network, Toronto Academic / other |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT06069700 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of personalized rehabilitative treatments for adults suffering from persistent postconcussion symptoms. Participants will undergo a standardized clinical examination to classify their symptoms into subgroups, allowing for tailored therapy. The primary outcome will be measured using The Rivermead Post-concussion Symptoms Questionnaire (RPQ) and a standardized clinical examination, compared to an active control group receiving usual care. Additionally, the study will assess changes in brain activity through advanced electroencephalography (EEG) before and after treatment.
Who should consider this trial
Good fit: Ideal candidates are adults aged 21 and older who have been diagnosed with postconcussion syndrome and report at least three persistent symptoms.
Not a fit: Patients with unremarkable clinical examinations or those with other significant neurological disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more effective rehabilitation strategies for individuals suffering from persistent concussion symptoms.
How similar studies have performed: While many studies have focused on single treatment modalities, this individualized approach is relatively novel and has not been extensively tested in this context.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 21-years and older * meet the definition of postconcussion syndrome, which requires a participant to report any 3 symptoms or more (from an inclusive list of 40 most commonly reported persisting symptoms) lasting at least 1-month following the diagnosis of a concussion. Concussion was defined according to the 5th International Consensus Statement on Concussion in Sport. * Have adequate language skills in English to read and take part in rehabilitation treatment program. Exclusion Criteria: * In-patients at Toronto Rehabilitation Institute or any other affiliated University Health Network clinics. * Participants will be excluded should their clinical examination be unremarkable for objective physical impairments, * Have a chronic infectious disease, * Uncontrolled hypertension, * Other neurological disorders (not attributed to their primary diagnosis), * Cancer treatment (other than basal cell carcinoma), craniotomy, or refractory subdural hematoma long-term use of psychoactive medications that would compromise their ability to comprehend and perform study activities, those with pacemakers or elevated cardiovascular risk, * Ongoing litigation surrounding their injury, * Have been diagnosed with a moderate or severe brain injury prior to enrolment, post-concussive symptoms persisting beyond 12-months.
Where this trial is running
Toronto, Ontario
- Toronto Rehabilitation Institute — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Milos R Popovic, PhD — University Health Network, Toronto
- Study coordinator: Nicholas Moser, DC
- Email: nicholas.moser@uhn.ca
- Phone: 416-597-3422
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.