Postconcussion SyndromeNCT06069700
Effectiveness of Rehabilitation in Adults Suffering From Persistent Concussion Symptoms
A study testing Non-pharmacological Individualized rehabilitative therapy in people with Postconcussion Syndrome and Mild Traumatic Brain Injury, run by University Health Network, Toronto at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Postconcussion Syndrome, Mild Traumatic Brain Injury
- What is being tested?
- Non-pharmacological Individualized rehabilitative therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 30 Jan 2023to 22 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Targeted Individualized Multi-modal Treatments in Adults Suffering From Persistent Concussion Symptoms as Compared to Usual Care
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.
Read more
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.
Read the detailed 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.
- Being tested
- Non-pharmacological Individualized rehabilitative therapy, Non-pharmacological Usual care therapy
- Medical subject headings
- Post-Concussion Syndrome, Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-pharmacological Individualized rehabilitative therapyOther
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.
Non-pharmacological Usual care therapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Individualized care program | Experimental | 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". Receives: Other: Non-pharmacological Individualized rehabilitative therapy |
| Usual care | Active comparator | 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. Receives: Other: Non-pharmacological Usual care therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rivermead Postconcussion Questionnaire
The Rivermead Post-Concussion Symptom Questionnaire (RPQ) is a self-report scale to measure the severity of post-concussive symptoms following a Traumatic Brain Injury (TBI).
Each item is rated on a 5-point ordinal scale: 0 = not experienced at all, 1 = no more of a problem, 2 = a mild problem, 3 = a moderate problem, and 4 = a severe problem. The total score is a sum of all items and ranges from 0 to 64 from (best to worst).
Measured: Baseline; 6-weeks; 12-weeks
Secondary outcomes (3)
Brain Vital Sign
Quantitative Electroencephalography (EEG). Brain vital sign as measured by rapid advanced electroencephalography (EEG) via NeuroCatchTM. NeuroCatch® conducts a rapid 6-minute scan to measure and report on three specific event related potentials (ERPs). ERPs are neurophysiological measures that are sensitive to changes in cognitive processing, which allows NeuroCatch® to assess an individual's cognitive brain health across various states. Specifically, the three ERPs, auditory N100 (auditory sensation); auditory oddball P300 (basic attention); and auditory speech processing N400 (cognitive processing) will be evaluated. Standardized normative data exists for all three ERP responses.
Measured: Baseline; 6-weeks; 12-weeks
Patient Health Questionnaire (PHQ-9)
The Patient Health Questionnaire (PHQ) is an instrument used for making criteria-based diagnoses of depressive and other mental disorders commonly encountered in primary care. To score the instrument, the numbers of all the checked responses under each heading are tallied (not at all=0, several days=1, more than half the days=2, and nearly every day=3). There are nine items / questions scored from 0 = not at all, 1 = several days, 2 = more than half the days, 3 = nearly every day. The total score is a sum of all items and ranges from 0 to 27 (best to worst).
Measured: Baseline; 6-weeks; 12-weeks
Neck Disability Index (NDI)
The Neck Disability Index (NDI) is a questionnaire designed to help us better understand how your neck pain affects your ability to manage everyday / life activities. The NDI has become a standard instrument for measuring self-rated disability due to neck pain and is used by both clinicians and researchers. Each of the 10 items scores from 0 to 5: 0 = no disability and 5 = complete. The maximum score is 50.
Measured: Baseline; 6-weeks; 12-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2023
- Study start30 Jan 2023
- Primary completion22 Apr 2025
- Study completion22 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postconcussion SyndromeStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized cas-crossover clinical trial
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- NeuroCatch Inc.
- Responsible party
- Sponsor
- Investigators
- Milos R Popovic, PhD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06069700
- Sponsor's protocol ID
- 22-5560
- Status last verified
- Mar 2025
- First submitted
- 22 Sep 2023
- Last updated
- 22 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared with any other researchers.
Publications
Moser N, Popovic MR, Kalsi-Ryan S. Effectiveness of personalized rehabilitation in adults suffering from persistent concussion symptoms as compared to usual care: a randomized control trial protocol. BMC Neurol. 2024 Jul 10;24(1):239. doi: 10.1186/s12883-024-03700-5.
PubMed 38987676
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Targeted Individualized Multi-modal Treatments in Adults Suffering From Persistent Concussion Symptoms as Compared to Usual Care
- ClinicalTrials.gov ID
- NCT06069700
- Acronym / sponsor ID
- 22-5560
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- NeuroCatch Inc.
- Study start
- 30 Jan 2023 (actual)
- Primary completion
- 22 Apr 2025 (actual)
- Study completion
- 22 Apr 2025 (actual)
- First posted
- 6 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized cas-crossover clinical trial
| Arm | Type | Receives |
|---|---|---|
| Individualized care program | Experimental | Other: Non-pharmacological Individualized rehabilitative therapyParticipants 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". |
| Usual care | Active comparator | Other: Non-pharmacological Usual care therapyActive 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-pharmacological Individualized rehabilitative therapyTreatments 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 | Individualized care program |
| Non-pharmacological Usual care therapyAll 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. | Other | Usual care |
Primary outcome
Rivermead Postconcussion Questionnaire
Time frame: Baseline; 6-weeks; 12-weeks
The Rivermead Post-Concussion Symptom Questionnaire (RPQ) is a self-report scale to measure the severity of post-concussive symptoms following a Traumatic Brain Injury (TBI). Each item is rated on a 5-point ordinal scale: 0 = not experienced at all, 1 = no more of a problem, 2 = a mild problem, 3 = a moderate problem, and 4 = a severe problem. The total score is a sum of all items and ranges from 0 to 64 from (best to worst).
3 secondary outcomes
Brain Vital Sign
Time frame: Baseline; 6-weeks; 12-weeks
Patient Health Questionnaire (PHQ-9)
Time frame: Baseline; 6-weeks; 12-weeks
Neck Disability Index (NDI)
Time frame: Baseline; 6-weeks; 12-weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
- Derived from this study: PubMed 38987676Moser N, Popovic MR, Kalsi-Ryan S. Effectiveness of personalized rehabilitation in adults suffering from persistent concussion symptoms as compared to usual care: a randomized control trial protocol. BMC Neurol. 2024 Jul 10;24(1):239. doi: 10.1186/s12883-024-03700-5.
- Individual participant dataSharing planned: No. Individual participant data will not be shared with any other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Milos R Popovic, PhD principal investigator
University Health Network, Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-pharmacological Individualized rehabilitative therapy in people with Postconcussion Syndrome and Mild Traumatic Brain Injury, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rivermead Postconcussion Questionnaire (time frame: Baseline; 6-weeks; 12-weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06069700, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2025.