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Behavioural Intervention

Rehabilitation for Persistent Concussion Symptoms

N/A

Recruiting

Led By Milos R Popovic, PhD

Research Sponsored by University Health Network, Toronto

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Meet the definition of postconcussion syndrome, which requires a participant to report any 3 symptoms or more lasting at least 1-month following the diagnosis of a concussion

Have adequate language skills in English to read and take part in rehabilitation treatment program

Must not have

Uncontrolled hypertension

Cancer treatment (other than basal cell carcinoma), craniotomy, or refractory subdural hematoma

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline; 6-weeks; 12-weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare individualized rehabilitative treatments to an active control to see how they affect recovery from post-concussion syndrome.

Who is the study for?

Adults over 21 with post-concussion syndrome, experiencing at least three symptoms for more than a month after a concussion. They must be able to read and understand English for the rehab program. Excluded are those with moderate/severe brain injury prior to enrollment, other neurological disorders, ongoing litigation related to their injury, certain medical conditions or treatments, long-term psychoactive medication use, pacemakers or high cardiovascular risk.

What is being tested?

The trial is testing individualized rehabilitative therapy against usual care therapy for persistent concussion symptoms. It's a crossover study where participants receive one treatment for six weeks then switch to the other. Recovery is measured using symptom questionnaires and EEG before and after each phase.

What are the potential side effects?

Since both interventions are non-pharmacological therapies focusing on rehabilitation rather than drugs, side effects may include discomfort from physical activities or fatigue due to cognitive exercises but no medicinal side effects.

Eligibility Criteria

Inclusion Criteria

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

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I have had three or more symptoms for over a month after my concussion.

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I can read and speak English well enough to participate in a rehab program.

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I am 21 years old or older.

Exclusion Criteria

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

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My high blood pressure is not under control.

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I have not had treatment for cancer (except for basal cell carcinoma), brain surgery, or severe brain bleeding.

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I have been diagnosed with a moderate or severe brain injury.

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My concussion symptoms have lasted for more than a year.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline; 6-weeks; 12-weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline; 6-weeks; 12-weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline; 6-weeks; 12-weeks 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 Postconcussion Questionnaire

Secondary study objectives

Brain Vital Sign

Neck Disability Index (NDI)

Patient Health Questionnaire (PHQ-9)

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Individualized care programExperimental Treatment1 Intervention

Participants in the individualized care stream, will be provided reassurance and psychoeducation via the bio-psycho-social model on understanding persistent symptoms consistent with usual care. Additionally, they will be afforded up to 12 treatments over the course of 6-weeks. Treatments will be standardized; however, given the heterogeneity of symptoms, components of the treatments will be individualized to the participants based on what subgroup they're classified into at baseline based on their initial clinical examination and self-reported dominant impairment. Regardless of subgroup classification, as part of individualized care, all patients will receive reassurance and psychoeducation about the bio-psycho-social understanding of persistent symptoms, including advice on adaptive illness behaviours, such as gradually resuming premorbid activities and avoiding excessive rest and "all-or-nothing behaviour".

Group II: Usual careActive Control1 Intervention

Active control - All participants in the active control group will receive 'usual care', (twice a week for 6 weeks), which will consist of reassurance and psychoeducation via the bio-psycho-social model on understanding persistent symptoms, including advice on adaptive illness behaviours, such as gradually resuming premorbid activities and avoiding excessive rest and "all-or-nothing behaviour". Additionally, participants will be afforded weekly 20-minute supervised progressive sub-symptom aerobic exercise sessions at the KITE clinic under the supervision of study coordinator. They will be instructed to also perform daily 20-minutes of subsymptom aerobic exercise outside the supervised exercise sessions.

0 / 7Eligibility criteria met