NCT06069700

Effectiveness of Rehabilitation in Adults Suffering From Persistent Concussion Symptoms

Completed NA Last updated 22 September 2025

What this trial tests

NA trial testing Non-pharmacological Individualized rehabilitative therapy in Postconcussion Syndrome in 40 participants. Completed in 22 April 2025.

Timeline

30 January 2023

Primary endpoint
22 April 2025

22 April 2025

Quick facts

Lead sponsor	University Health Network, Toronto
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	treatment
Enrollment	40
Start date	30 January 2023
Primary completion	22 April 2025
Estimated completion	22 April 2025
Sites	1 location across Canada

Drugs / interventions tested

• Non-pharmacological Individualized rehabilitative therapy
• Non-pharmacological Usual care therapy

Conditions studied

• Postconcussion Syndrome — all drugs for Postconcussion Syndrome →
• Mild Traumatic Brain Injury — all drugs for Mild Traumatic Brain Injury →

Sponsor

University Health Network, Toronto

Who can join

21 and older, any sex, with Postconcussion Syndrome or Mild Traumatic Brain Injury. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Effectiveness of personalized rehabilitation in adults suffering from persistent concussion symptoms as compared to usual care: a randomized control trial protocol.
   Moser N, Popovic MR, Kalsi-Ryan S. · · 2024 · cited 1× · PMID 38987676 · DOI 10.1186/s12883-024-03700-5
2. Effectiveness of Personalized Rehabilitation in Adults Suffering from Persistent Concussion Symptoms as Compared to Usual Care: A Randomized Control Trial Protocol
   Moser N, Popovic MR, Kalsi-Ryan S. · · 2024 · DOI 10.21203/rs.3.rs-3951661/v1