Effectiveness of Rehabilitation in Adults Suffering From Persistent Concussion Symptoms

Summary

Protocol Summary

The present study was developed to better understand the effects and benefits of individualizing rehabilitative treatments based on subgroup classifications determined by a standardized clinical examination. The primary aim is to evaluate the response to individualized therapy on recovery, as measured by The Rivermead Post-concussion Symptoms Questionnaire (RPQ) and standardized clinical examination, when compared to an active control. The secondary aim is to evaluate the Pre and Post treatment state of the participants via a rapid advanced electroencephalography (EEG) when compared to the active control who will be provided the current standard form of therapy for persistent symptoms. The EEG changes will be compared to the standardized clinical examination findings as well as the RPQ.

Sample Size:

N= 50

Study Population

Participants will be eligible for study participation if they meet the following inclusion criteria: 21-years and older; diagnosed with postconcussion syndrome; and have adequate language skills in English to read and take part in rehabilitation treatment program. Participants will be excluded should: they have an unremarkable or normal clinical examination; 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.

Study Design

The investigators will be conducting a 12-week case-crossover randomized controlled trial. Participants will undergo 6-weeks of care in their respective streams. After 6-weeks, participants will undergo a re-examination. They will then crossover and undertake the alternative treatment for 6-weeks. At the end of 12-weeks, participants will undertake the endpoint examinations.

Start Date:

May 2023

End Date:

September 2025

Primary Objective:

The primary aim is to evaluate the response to individualized therapy on recovery, as measured by The Rivermead Post-concussion Symptoms Questionnaire (RPQ) and standardized clinical examination, when compared to an active control.

Conditions

• Postconcussion Syndrome
• Mild Traumatic Brain Injury

Interventions

OTHER

Non-pharmacological Individualized rehabilitative therapy

Treatments will be standardized but 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. \*Physiological group - Participants will receive supervised sub-symptom aerobic exercise 20-minutes twice per week and mindfulness-based training 20-minutes twice per week. \*Cervical group - Participants will receive physical therapy to the cervical spine. Physical therapy will include soft tissue therapy directed to the cervical myofascial tissues, and graded cervical spine facet mobilizations. \*Vestibulo-Ocular group - Patients classified to vestibulo-ocular subgroup will receive bi-weekly 30-minute individualized oculomotor, vestibular and balance exercises including adaptation exercises, gaze stability exercises, visual-vestibular integration exercises, habituation exercises, static and dynamic balance exercises.

OTHER

Non-pharmacological Usual care therapy

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 NM. They will be instructed to also perform daily 20-minutes of subsymptom aerobic exercise outside the supervised exercise sessions.

Sponsors & Collaborators

• NeuroCatch Inc.

  collaborator INDUSTRY

• University Health Network, Toronto

  lead OTHER

Principal Investigators

• Milos R Popovic, PhD · University Health Network, Toronto

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

21 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-01-30

Primary Completion

2025-04-22

Completion

2025-04-22

Countries

• Canada

Study Locations