50 Participants Needed

Rehabilitation for Persistent Concussion Symptoms

NM
SK
Overseen BySukhvinder Kalsi-Ryan, PhD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

Protocol SummaryThe 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= 50Study PopulationParticipants 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 DesignThe 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 2023End Date:September 2025Primary 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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on long-term psychoactive medications that affect your ability to understand and perform study activities, you may not be eligible to participate.

Is non-pharmacological rehabilitation therapy safe for treating persistent concussion symptoms?

The research suggests that non-pharmacological rehabilitation therapies, which include personalized and individualized approaches, are generally safe for managing prolonged concussion symptoms. These therapies often involve strategies like psychoeducation and cognitive strategy instruction, which are non-invasive and focus on improving cognitive functions such as attention and memory.12345

How is the treatment for persistent concussion symptoms unique?

This treatment is unique because it offers a personalized and dynamic approach, focusing on non-drug therapies like psychoeducation and cognitive strategy instruction, tailored to the individual's specific symptoms and progress, unlike standard treatments that often rely on medications.15678

What data supports the effectiveness of this treatment for persistent concussion symptoms?

Research suggests that personalized approaches, including psychoeducation (teaching about the condition) and cognitive strategy instruction (teaching ways to improve thinking skills), can help manage prolonged concussion symptoms by addressing issues with attention, memory, and planning. These methods are tailored to each person's symptoms and progress, making them potentially effective for improving daily functioning.125910

Who Is on the Research Team?

MR

Milos R Popovic, PhD

Principal Investigator

University Health Network, Toronto

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

A concussion is determined based on guidelines from the 5th International Consensus Statement on Concussion in Sport.
I have had three or more symptoms for over a month after my concussion.
I am 21 years old or older.

Exclusion Criteria

Other brain or nerve disorders not related to their main diagnosis.
You have been taking certain medications for a long time that might affect your ability to understand and participate in the study.
You are currently involved in a legal case related to your injury.
See 8 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Phase 1

Participants receive either individualized care or usual care for 6 weeks

6 weeks
Up to 12 treatments over 6 weeks

Crossover Treatment Phase

Participants crossover to the alternative treatment for another 6 weeks

6 weeks
Up to 12 treatments over 6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Non-pharmacological Individualized rehabilitative therapy
  • Non-pharmacological Usual care therapy
Trial Overview 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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Individualized care programExperimental Treatment1 Intervention
Group II: Usual careActive Control1 Intervention

Non-pharmacological Individualized rehabilitative therapy is already approved in Canada, United States for the following indications:

🇨🇦
Approved in Canada as Individualized Concussion Rehabilitation for:
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Approved in United States as Personalized Rehabilitation for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials
1,555
Recruited
526,000+

NeuroCatch Inc.

Industry Sponsor

Trials
9
Recruited
1,200+

Published Research Related to This Trial

Psychoeducation and cognitive strategy instruction are effective treatment components for addressing prolonged concussion symptoms (PCS), particularly for cognitive impairments in attention, working memory, and executive functioning.
A personalized, dynamic approach to managing PCS, which includes individualized tracking of progress and treatment adaptation based on client performance, shows promise in effectively targeting functional goals disrupted by concussion.
The Implementation of a Personalized Dynamic Approach for the Management of Prolonged Concussion Symptoms.Wright, J., Sohlberg, MM.[2021]
A systematic review of 11 randomized controlled trials involving concussion recovery found no strong evidence that early pharmacological treatments improve recovery within the first two weeks after injury.
However, some non-pharmacological interventions, like manual therapy and telephone counseling, showed significant improvements in concussion symptoms, suggesting that these approaches may be beneficial for recovery.
Early intervention treatment in the first 2 weeks following concussion in adults: A systematic review of randomised controlled trials.Moore, S., Musgrave, C., Sandler, J., et al.[2023]
Most individuals recover quickly and fully from a single, uncomplicated concussion, but some may experience unexpected difficulties during recovery.
A neuropsychological evaluation can identify factors that prolong recovery, allowing for tailored interventions to improve patient functioning and reduce distress.
The Role of Neuropsychological Evaluation in the Clinical Management of Concussion.Connery, AK., Peterson, RL., Baker, DA., et al.[2018]

Citations

The Implementation of a Personalized Dynamic Approach for the Management of Prolonged Concussion Symptoms. [2021]
Early intervention treatment in the first 2 weeks following concussion in adults: A systematic review of randomised controlled trials. [2023]
The Role of Neuropsychological Evaluation in the Clinical Management of Concussion. [2018]
Management of Persistent Cognitive Symptoms After Sport-Related Concussion. [2018]
A Treatment-Based Profiling Model for Physical Therapy Management of Patients Following a Concussive Event. [2020]
New treatments for concussion: the next millennium beckons. [2019]
Adapting the Dynamic, Recursive Model of Sport Injury to Concussion: An Individualized Approach to Concussion Prevention, Detection, Assessment, and Treatment. [2020]
Managing Patients with Prolonged Recovery Following Concussion. [2018]
From the field of play to the field of combat: a review of the pharmacological management of concussion. [2021]
10.United Statespubmed.ncbi.nlm.nih.gov
The Role of Physical Therapy in Concussion Rehabilitation. [2020]
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