Evaluation of the Impact of a Dietary and Nutritional Intervention on Persistent Post-concussive Symptoms

Study Overview
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Brief Summary
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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.

Detailed Description
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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. Some studies have explored the impact of pharmaceuticals on treating post-concussive symptoms. Still, these have shown little success, leading the scientific community to consider multidisciplinary approaches to treating and managing concussions. Recently, it has been suggested that nutritional interventions should be considered in concussion management because nutrition can act on several mechanisms of brain injury. Some nutritional supplements have shown beneficial effects on the speed of recovery and the degree of severity of symptoms related to moderate or severe head trauma. Other studies have shown a link between malnutrition and low neurological and cognitive scores. 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. The use of three groups will help determine the individual impact of dietetic treatment offered by a dietitian and the use of supplements. Patient symptoms will be measured using a questionnaire constructed from tools commonly used in practice by medical doctors, physiotherapists and dietitians. This questionnaire will be completed at the first physiotherapy session and 2, 4 and 8 weeks after the start of the intervention.

Official Title
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Evaluation of the Impact of a Dietary and Nutritional Intervention on the Physical, Cognitive, Behavioural and Emotional Symptoms of Patients With Persistent Post-concussive Symptoms

Conditions
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Brain Injury Traumatic Mild

Intervention / Treatment
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* Behavioral: Experimental: Dietetic counseling
* Dietary Supplement: Active Comparator: Omega-3, vitamin D3 and creatine monohydrate
* Behavioral: Other : Physiotherapy treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: <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 Any physical condition prohibiting a patient from receiving physiotherapy treatments

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dietary intervention and nutritional supplements (group A)<br>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 (2500mg/day), vitamin D (2000 IU/day) and creatine monohydrate (10mg/day) supplements prescribed by their doctor. | Behavioral: Experimental: Dietetic counseling<br>* Patients will receive dietary counselling to increase caloric and nutrient intake, stabilize glycemia, and optimize hydration.<br>Dietary Supplement: Active Comparator: Omega-3, vitamin D3 and creatine monohydrate<br>* Patients will be prescribed dietary supplements which will be taken daily for 8 weeks, as per the supplement protocol.<br>Behavioral: Other : Physiotherapy treatment<br>* Patients will receive weekly physiotherapy treatment.<br>|
| Active Comparator: Nutritional supplements (group B)<br>Patients in group B will be prescribed omega-3 (2500mg/day), vitamin D (2000 IU/day) and creatine monohydrate (10mg/day) supplements and receive physiotherapy treatments over eight weeks. | Dietary Supplement: Active Comparator: Omega-3, vitamin D3 and creatine monohydrate<br>* Patients will be prescribed dietary supplements which will be taken daily for 8 weeks, as per the supplement protocol.<br>Behavioral: Other : Physiotherapy treatment<br>* Patients will receive weekly physiotherapy treatment.<br>|
| Other: Physiotherapy treatment (control group)<br>Patients in the control group will receive physiotherapy treatments over eight weeks. | Behavioral: Other : Physiotherapy treatment<br>* Patients will receive weekly physiotherapy treatment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | Baseline and Endpoint (Week 8) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline and Endpoint (Week 8) | 
| 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). | Baseline and Endpoint (Week 8) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dietary intervention, Supplements, Omega-3, Vitamin D, Creatine monohydrate