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| Name | Class |
|---|---|
| New Brunswick Health Research Foundation | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dietary intervention and nutritional supplements (group A) | Experimental | 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. |
|
| Nutritional supplements (group B) | Active Comparator | 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. |
|
| Physiotherapy treatment (control group) | Other | Patients in the control group will receive physiotherapy treatments over eight weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental: Dietetic counseling | Behavioral | Patients will receive dietary counselling to increase caloric and nutrient intake, stabilize glycemia, and optimize hydration. |
|
| 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) |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stephanie Ward Chiasson, PhD, RD | Contact | 506-858-4000 | 4090 | stephanie.ward@umoncton.ca |
| Horia-Daniel Iancu, PhD | Contact | 506-858-4000 | 4999 | horia-daniel.iancu@umoncton.ca |
| Name | Affiliation | Role |
|---|---|---|
| Stephanie Ward Chiasson, PhD, RD | Universite de Moncton | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universite de Moncton | Recruiting | Moncton | New Brunswick | E1A 3E9 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30202575 | Background | Ainsley Dean PJ, Arikan G, Opitz B, Sterr A. Potential for use of creatine supplementation following mild traumatic brain injury. Concussion. 2017 Mar 21;2(2):CNC34. doi: 10.2217/cnc-2016-0016. eCollection 2017 Jun. | |
| 23326789 | Background | Aminmansour B, Nikbakht H, Ghorbani A, Rezvani M, Rahmani P, Torkashvand M, Nourian M, Moradi M. Comparison of the administration of progesterone versus progesterone and vitamin D in improvement of outcomes in patients with traumatic brain injury: A randomized clinical trial with placebo group. Adv Biomed Res. 2012;1:58. doi: 10.4103/2277-9175.100176. Epub 2012 Aug 28. |
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Data will be made available to researchers upon reasonable request made to the principal investigator.
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| Active Comparator: Omega-3, vitamin D3 and creatine monohydrate | Dietary Supplement | Patients will be prescribed dietary supplements which will be taken daily for 8 weeks, as per the supplement protocol. |
|
| Other : Physiotherapy treatment | Behavioral | Patients will receive weekly physiotherapy treatment. |
|
| 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) |
| 27037788 | Background | Annweiler C, Milea D, Whitson HE, Cheng CY, Wong TY, Ikram MK, Lamoureux EL, Sabanayagam C. Vitamin D insufficiency and cognitive impairment in Asians: a multi-ethnic population-based study and meta-analysis. J Intern Med. 2016 Sep;280(3):300-11. doi: 10.1111/joim.12491. Epub 2016 Apr 1. |
| 25642858 | Background | Baltazar GA, Pate AJ, Panigrahi B, LaBoy S, Prosniak R, Mody A, Chendrasekhar A. Malnutrition as measured by albumin and prealbumin on admission is associated with poor outcomes after severe traumatic brain injury. Am Surg. 2015 Feb;81(2):E61-3. No abstract available. |
| 31851345 | Background | Breck J, Bohr A, Poddar S, McQueen MB, Casault T. Characteristics and Incidence of Concussion Among a US Collegiate Undergraduate Population. JAMA Netw Open. 2019 Dec 2;2(12):e1917626. doi: 10.1001/jamanetworkopen.2019.17626. |
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| 30086660 | Background | Dolan E, Gualano B, Rawson ES. Beyond muscle: the effects of creatine supplementation on brain creatine, cognitive processing, and traumatic brain injury. Eur J Sport Sci. 2019 Feb;19(1):1-14. doi: 10.1080/17461391.2018.1500644. Epub 2018 Aug 7. |
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| 34579748 | Background | Heileson JL, Anzalone AJ, Carbuhn AF, Askow AT, Stone JD, Turner SM, Hillyer LM, Ma DWL, Luedke JA, Jagim AR, Oliver JM. The effect of omega-3 fatty acids on a biomarker of head trauma in NCAA football athletes: a multi-site, non-randomized study. J Int Soc Sports Nutr. 2021 Sep 27;18(1):65. doi: 10.1186/s12970-021-00461-1. |
| 22028384 | Background | Hou R, Moss-Morris R, Peveler R, Mogg K, Bradley BP, Belli A. When a minor head injury results in enduring symptoms: a prospective investigation of risk factors for postconcussional syndrome after mild traumatic brain injury. J Neurol Neurosurg Psychiatry. 2012 Feb;83(2):217-23. doi: 10.1136/jnnp-2011-300767. Epub 2011 Oct 25. |
| 24983072 | Background | Institute of Medicine (US) Committee on Nutrition, Trauma, and the Brain; Erdman J, Oria M, Pillsbury L, editors. Nutrition and Traumatic Brain Injury: Improving Acute and Subacute Health Outcomes in Military Personnel. Washington (DC): National Academies Press (US); 2011. Available from http://www.ncbi.nlm.nih.gov/books/NBK209314/ |
| 31246881 | Background | Langer L, Levy C, Bayley M. Increasing Incidence of Concussion: True Epidemic or Better Recognition? J Head Trauma Rehabil. 2020 Jan/Feb;35(1):E60-E66. doi: 10.1097/HTR.0000000000000503. |
| 30904798 | Background | Lee JM, Jeong SW, Kim MY, Park JB, Kim MS. The Effect of Vitamin D Supplementation in Patients with Acute Traumatic Brain Injury. World Neurosurg. 2019 Jun;126:e1421-e1426. doi: 10.1016/j.wneu.2019.02.244. Epub 2019 Mar 20. |
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| 27705610 | Background | Lucke-Wold BP, Logsdon AF, Nguyen L, Eltanahay A, Turner RC, Bonasso P, Knotts C, Moeck A, Maroon JC, Bailes JE, Rosen CL. Supplements, nutrition, and alternative therapies for the treatment of traumatic brain injury. Nutr Neurosci. 2018 Feb;21(2):79-91. doi: 10.1080/1028415X.2016.1236174. Epub 2016 Oct 5. |
| 28102739 | Background | Mah K, Hickling A, Reed N. Perceptions of mild traumatic brain injury in adults: a scoping review. Disabil Rehabil. 2018 Apr;40(8):960-973. doi: 10.1080/09638288.2016.1277402. Epub 2017 Jan 19. |
| 25970337 | Background | Margulies S, Anderson G, Atif F, Badaut J, Clark R, Empey P, Guseva M, Hoane M, Huh J, Pauly J, Raghupathi R, Scheff S, Stein D, Tang H, Hicks M. Combination Therapies for Traumatic Brain Injury: Retrospective Considerations. J Neurotrauma. 2016 Jan 1;33(1):101-12. doi: 10.1089/neu.2014.3855. Epub 2015 Aug 6. |
| 28446457 | Background | McCrory P, Meeuwisse W, Dvorak J, Aubry M, Bailes J, Broglio S, Cantu RC, Cassidy D, Echemendia RJ, Castellani RJ, Davis GA, Ellenbogen R, Emery C, Engebretsen L, Feddermann-Demont N, Giza CC, Guskiewicz KM, Herring S, Iverson GL, Johnston KM, Kissick J, Kutcher J, Leddy JJ, Maddocks D, Makdissi M, Manley GT, McCrea M, Meehan WP, Nagahiro S, Patricios J, Putukian M, Schneider KJ, Sills A, Tator CH, Turner M, Vos PE. Consensus statement on concussion in sport-the 5th international conference on concussion in sport held in Berlin, October 2016. Br J Sports Med. 2017 Jun;51(11):838-847. doi: 10.1136/bjsports-2017-097699. Epub 2017 Apr 26. No abstract available. |
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| 24855132 | Background | Schneider KJ, Meeuwisse WH, Nettel-Aguirre A, Barlow K, Boyd L, Kang J, Emery CA. Cervicovestibular rehabilitation in sport-related concussion: a randomised controlled trial. Br J Sports Med. 2014 Sep;48(17):1294-8. doi: 10.1136/bjsports-2013-093267. Epub 2014 May 22. |
| 29385179 | Background | Theadom A, Starkey N, Barker-Collo S, Jones K, Ameratunga S, Feigin V; BIONIC4you Research Group. Population-based cohort study of the impacts of mild traumatic brain injury in adults four years post-injury. PLoS One. 2018 Jan 31;13(1):e0191655. doi: 10.1371/journal.pone.0191655. eCollection 2018. |
| 26723564 | Background | Vonder Haar C, Peterson TC, Martens KM, Hoane MR. Vitamins and nutrients as primary treatments in experimental brain injury: Clinical implications for nutraceutical therapies. Brain Res. 2016 Jun 1;1640(Pt A):114-129. doi: 10.1016/j.brainres.2015.12.030. Epub 2015 Dec 23. |
| 24074905 | Background | Wahls T, Rubenstein L, Hall M, Snetselaar L. Assessment of dietary adequacy for important brain micronutrients in patients presenting to a traumatic brain injury clinic for evaluation. Nutr Neurosci. 2014 Nov;17(6):252-9. doi: 10.1179/1476830513Y.0000000088. Epub 2013 Nov 26. |
| 21851229 | Background | Wu A, Ying Z, Gomez-Pinilla F. The salutary effects of DHA dietary supplementation on cognition, neuroplasticity, and membrane homeostasis after brain trauma. J Neurotrauma. 2011 Oct;28(10):2113-22. doi: 10.1089/neu.2011.1872. Epub 2011 Oct 4. |
| 15672635 | Background | Wu A, Ying Z, Gomez-Pinilla F. Dietary omega-3 fatty acids normalize BDNF levels, reduce oxidative damage, and counteract learning disability after traumatic brain injury in rats. J Neurotrauma. 2004 Oct;21(10):1457-67. doi: 10.1089/neu.2004.21.1457. |
| 26954410 | Background | Zemek R, Barrowman N, Freedman SB, Gravel J, Gagnon I, McGahern C, Aglipay M, Sangha G, Boutis K, Beer D, Craig W, Burns E, Farion KJ, Mikrogianakis A, Barlow K, Dubrovsky AS, Meeuwisse W, Gioia G, Meehan WP 3rd, Beauchamp MH, Kamil Y, Grool AM, Hoshizaki B, Anderson P, Brooks BL, Yeates KO, Vassilyadi M, Klassen T, Keightley M, Richer L, DeMatteo C, Osmond MH; Pediatric Emergency Research Canada (PERC) Concussion Team. Clinical Risk Score for Persistent Postconcussion Symptoms Among Children With Acute Concussion in the ED. JAMA. 2016 Mar 8;315(10):1014-25. doi: 10.1001/jama.2016.1203. |
| ID | Term |
|---|---|
| D001924 | Brain Concussion |
| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D016489 | Head Injuries, Closed |
| D014947 | Wounds and Injuries |
| D014949 | Wounds, Nonpenetrating |
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| ID | Term |
|---|---|
| D002762 | Cholecalciferol |
| D003401 | Creatine |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
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