Effectiveness of Rehabilitation in Adults Suffering From Persistent Concussion Symptoms

University Health Network, Toronto

Status: Enrolling

Conditions: Mild Traumatic Brain Injury; Postconcussion Syndrome

Treatments: Other: Non-pharmacological Usual care therapy; Other: Non-pharmacological Individualized rehabilitative therapy

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06069700

22-5560

Details and patient eligibility

About

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.

Full description

Background and Rationale

Disabilities secondary to traumatic brain injury are a major source of burden. Numerous treatments have been utilized and studied in an attempt to treat persistent postconcussive symptoms. However, the majority of clinical trials examined the efficacy of a single treatment. Given mild traumatic brain injury (mTBI) is a heterogenous condition characterized by a variety of clinical presentations, one could assume a lack of recovery or response to therapy when done in isolation.

The present study was developed to better understand the effects of individualized rehabilitative care in concussion patients. Specifically, the investigators seek to better understand the effects and benefits of individualizing rehabilitative treatments based on subgroup classifications determined by a standardized clinical examination. The investigators' intention is to establish a treatment methodology based on subgroup classification to individualized rehabilitative treatment programs. 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 EEG when compared to the active control who will be provided the current standard form of therapy for persistent symptoms. The electrophysiological changes will be compared to the standardized clinical examination findings as well as the RPQ.

Hypothesis

The investigators hypothesize that participants suffering from persistent post-concussive symptoms, with dominant somatic features, undergoing an individualized rehabilitation program derived from subgroup classification will demonstrate clinically meaningful and statistically significant improved RPQ scores when compared to the active control who will be provided the current standard form of therapy for persistent symptoms. Additionally, the investigators expect significantly improved brain vital sign as measured by rapid EEG, which will serve as a biomarker to confirm the clinical changes.

The investigators will be conducting a 12-week case-crossover randomized controlled trial. Participants will be randomized at baseline to either the individualized care program or an active control. No washout period will be used between interventions. It was assumed that given both interventional groups have a focus on rehabilitative therapy that no wash-out period was needed. 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 21-years and older
• meet the definition of postconcussion syndrome, which requires a participant to report any 3 symptoms or more (from an inclusive list of 40 most commonly reported persisting symptoms) lasting at least 1-month following the diagnosis of a concussion. Concussion was defined according to the 5th International Consensus Statement on Concussion in Sport.
• Have adequate language skills in English to read and take part in rehabilitation treatment program.

Exclusion criteria

• In-patients at Toronto Rehabilitation Institute or any other affiliated University Health Network clinics.
• Participants will be excluded should their clinical examination be unremarkable for objective physical impairments,
• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Individualized care program

Experimental group

Description:

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".

Treatment:

Other: Non-pharmacological Individualized rehabilitative therapy

Usual care

Active Comparator group

Description:

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.

Treatment:

Other: Non-pharmacological Usual care therapy