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

50 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 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. ^{1 2 3 4 5}

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. ^{1 2 5 6 7}

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. ^{1 2 8 9 10}

Research Team

Milos R Popovic, PhD

Principal Investigator

University Health Network, Toronto

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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 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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

The Implementation of a Personalized Dynamic Approach for the Management of Prolonged Concussion Symptoms. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Early intervention treatment in the first 2 weeks following concussion in adults: A systematic review of randomised controlled trials. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

The Role of Neuropsychological Evaluation in the Clinical Management of Concussion. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Management of Persistent Cognitive Symptoms After Sport-Related Concussion. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

A Treatment-Based Profiling Model for Physical Therapy Management of Patients Following a Concussive Event. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

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

7. United States 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. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

Managing Patients with Prolonged Recovery Following Concussion. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

From the field of play to the field of combat: a review of the pharmacological management of concussion. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

The Role of Physical Therapy in Concussion Rehabilitation. [2020]