Rehabilitation for Persistent Concussion Symptoms

Overseen By Sukhvinder Kalsi-Ryan, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University Health Network, Toronto

Must not be taking: Psychoactive medications

Disqualifiers: Chronic infectious disease, Uncontrolled hypertension, Other neurological disorders, Cancer treatment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 24

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how personalized rehab treatments aid recovery from persistent concussion symptoms. Participants will experience two approaches: a customized care plan tailored to their specific needs and usual care, which includes education and exercise. The trial aims to determine which approach is more effective by assessing symptom improvements and brain activity. Suitable candidates have experienced concussion symptoms for at least a month and can communicate well in English. As an unphased trial, this study provides a unique opportunity to contribute to innovative rehabilitation strategies that could enhance recovery for many.

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.

What prior data suggests that this protocol is safe for participants?

Research has shown that personalized therapy for post-concussion symptoms is generally safe. This therapy, tailored to each person's specific needs, is well-received by patients. For instance, a study on a 6-week personalized rehabilitation program found significant symptom improvement without major safety issues.

Standard care therapy, which includes reassurance, education about the condition, and supervised exercise, is also considered safe. Clinics commonly use these methods to manage ongoing concussion symptoms.

Both treatment approaches focus on non-drug methods, avoiding medication. This often results in fewer side effects compared to drug-based treatments. Participants in past studies have not reported any major negative effects, suggesting these therapies are safe options for managing post-concussion symptoms. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative ways to manage persistent concussion symptoms without medication. Unlike standard treatments that often focus on medications or limited physical therapy, this trial investigates two non-pharmacological approaches. The individualized care program stands out because it tailors treatment to each participant's unique symptoms, combining reassurance, psychoeducation, and custom therapy sessions. Meanwhile, the usual care group also integrates psychoeducation but adds structured, progressive aerobic exercise, which is not typically a focus in standard care. This trial aims to uncover more effective strategies for helping patients gradually resume their normal activities and improve recovery outcomes.

What evidence suggests that this trial's treatments could be effective for postconcussion syndrome?

Research has shown that personalized therapy can help treat ongoing concussion symptoms. In this trial, participants in the individualized care program will receive personalized rehabilitation, which studies have shown improves symptoms as measured by specific questionnaires. One study demonstrated that non-drug therapies, such as physical therapy, significantly improved physical symptoms in people with long-lasting concussions. Additionally, a review of various studies found that these non-drug treatments often led to noticeable improvements. These approaches focus on tailoring treatments to each person's needs, enhancing recovery. Overall, evidence supports that these personalized strategies can help manage long-term symptoms after a concussion. ^{1 2 6 7 8}

Who Is on the Research Team?

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.

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?

Group I: Individualized care program Experimental Treatment 1 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 care Active Control 1 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.

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

Approved in Canada as Individualized Concussion Rehabilitation for:

• Persistent Concussion Symptoms
• Post-Concussion Syndrome

Approved in United States as Personalized Rehabilitation for:

• Concussion Rehabilitation
• Post-Concussion Syndrome

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

A new treatment-based profiling model has been proposed to assist physical therapists in managing patients after a concussion, focusing on symptom type, intensity, and movement response.

The model emphasizes three key treatment areas: symptom management, movement system optimization, and performance optimization, which can help therapists make informed decisions tailored to individual patient needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Treatment-Based Profiling Model for Physical Therapy Management of Patients Following a Concussive Event. Alsalaheen, B., Landel, R., Hunter-Giordano, A., et al.[2020]

In a review of 24 cases of students with persistent cognitive symptoms after sport-related concussions, 83% achieved their self-selected functional goals through individualized interventions by speech-language pathologists.

The treatments included direct attention training, metacognitive strategy training, assistive technology training, and psychoeducational supports, highlighting a range of effective strategies for managing post-concussion cognitive issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of Persistent Cognitive Symptoms After Sport-Related Concussion. Sohlberg, MM., Ledbetter, AK.[2018]

Concussion risk factors can be divided into intrinsic (individual-specific) and extrinsic (environmental or sport-related), highlighting the importance of a personalized approach to prevention and management.

Most concussion symptoms resolve within a few days, but if they last longer than 7 to 10 days, a comprehensive interdisciplinary assessment is necessary to guide treatment, emphasizing the need for tailored rehabilitation strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adapting the Dynamic, Recursive Model of Sport Injury to Concussion: An Individualized Approach to Concussion Prevention, Detection, Assessment, and Treatment. Schneider, KJ., Emery, CA., Black, A., et al.[2020]

A multidisciplinary approach is essential for effectively managing concussions in children and adolescents, highlighting the importance of Physical Therapists in the recovery process.

Targeted treatments such as vestibular rehabilitation, cervicogenic rehabilitation, and exertional training can help alleviate common concussion symptoms like headache, dizziness, and balance dysfunction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Role of Physical Therapy in Concussion Rehabilitation. Brown, L., Camarinos, J.[2020]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Postconcussion syndrome can lead to persistent and debilitating symptoms, making it essential for clinicians to conduct thorough evaluations to create personalized treatment plans for patients.

Pharmacologic interventions may be beneficial for patients experiencing prolonged symptoms that significantly impact their quality of life, highlighting the importance of evidence-based approaches in managing these cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Managing Patients with Prolonged Recovery Following Concussion. Miller Phillips, M., Reddy, CC.[2018]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Role of Neuropsychological Evaluation in the Clinical Management of Concussion. Connery, AK., Peterson, RL., Baker, DA., et al.[2018]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Implementation of a Personalized Dynamic Approach for the Management of Prolonged Concussion Symptoms. Wright, J., Sohlberg, MM.[2021]

Current research highlights the need for pharmacological therapies for mild traumatic brain injury and concussion, as understanding of these conditions improves.

However, there is currently no effective medication that meets the highest standards of evidence-based medicine (Class I evidence) for treating these injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New treatments for concussion: the next millennium beckons. McCrory, P.[2019]

Most concussion symptoms resolve on their own with rest, but some patients may need medication for prolonged recovery, highlighting the importance of individualized treatment plans.

Current pharmacologic treatments for concussion are largely symptom-based and lack strong evidence, indicating a need for more rigorous clinical trials to evaluate their efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

From the field of play to the field of combat: a review of the pharmacological management of concussion. Petraglia, AL., Maroon, JC., Bailes, JE.[2021]

Citations

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