About this trial
Concussions affect thousands of Canadians every year. Although the effects are usually temporary, 10-15% of adults experience persistent symptoms likely to last several weeks or even months. It is suggested that nutritional interventions should be considered in concussion management because nutrition can act on several mechanisms of brain injury. However, to date, no study has assessed the impact of dietary interventions on the recovery of people with persistent post-concussive symptoms.
This randomized controlled trial aims to determine the impact of a dietary and nutritional intervention on the physical, cognitive, behavioural and emotional symptoms of patients with persistent post-concussive symptoms in New Brunswick, Canada. Patients will be randomized to one of three groups: 1) dietary treatments and nutritional supplements (experimental group A), 2) nutritional supplements (experimental group B), and 3) physiotherapy treatments (control group). Patients in group A will receive four consultations with a dietitian over eight weeks, in addition to conventional physiotherapy treatments. These patients will receive nutritional counselling and omega-3, vitamin D and creatine supplements. Patients in group B will be prescribed the same supplements as those in group A by their doctor and receive physiotherapy treatments. Finally, patients in the control group will only receive physiotherapy treatments. Patient symptoms will be measured using a questionnaire constructed from tools commonly used in practice. This questionnaire will be completed at the first physiotherapy session and 2, 4 and 8 weeks after the start of the intervention.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
16 years or older
Must be able to understand English or French
Have persistent post-concussive symptoms lasting at least 2 weeks but no longer than 6 months
Disqualifiers
<16 years old
People who are breastfeeding, pregnant or plan to become pregnant in the next 2 months
People with neurological disorders (other than concussion) or a history of moderate or severe brain injury
People in an acute phase of an inflammatory bowel disease
Trial design
Parallel
Treatments tested in this trial
Experimental: Dietetic counseling
BehavioralPatients will receive dietary counselling to increase caloric and nutrient intake, stabilize glycemia, and optimize hydration.
Active Comparator: Omega-3, vitamin D3 and creatine monohydrate
Dietary supplementPatients will be prescribed dietary supplements which will be taken daily for 8 weeks, as per the supplement protocol.
Other : Physiotherapy treatment
BehavioralPatients will receive weekly physiotherapy treatment.
Treatment groups
Trial outcomes
Primary outcomes
Change from baseline in severity of post-concussive symptoms at the end of the intervention
Patients' severity of post-concussive symptoms will be measured using the 5th edition of the Sport Concussion Assessment Tool (SCAT5). This tool assesses the degree of severity of 22 concussion-related symptoms, on a scale of 0 (no symptoms) to 6 (severe). The total number of perceived symptoms is noted by the physiotherapist, and a symptom severity score is calculated (scale from 0 to 132 points).
Secondary outcomes
Change from baseline in balance at the end of the intervention
The physiotherapist will assess patients' balance using the Modified Balance Error Scoring System (mBESS) test. This objective and validated tool is complimentary to the SCAT5 and is scored from 0 to 30 points, where a greater score indicates severe balance impairment.
Change from baseline in vestibular ocular motor at the end of the intervention
The physiotherapist will assess patients' vestibular ocular motor using the Vestibular Ocular Screening (VOMS) test (Mucha et al., 2014). This tool measures five domains, including smooth pursuits, saccades (rapid eye movements), near-point convergence, balance vision reflex and visual motion sensitivity. For each domain, the sum of the symptoms is scored, with a total possible score of 0 (no change) to 200 points (significant changes in symptom severity).
Sponsors and contacts
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Universite de Moncton
Lead sponsor
New Brunswick Health Research Foundation
Collaborator