Brain Injury Traumatic MildNCT05589064
Evaluation of the Impact of a Dietary and Nutritional Intervention on Persistent Post-concussive Symptoms
A study testing Experimental: Dietetic counseling, Active Comparator: Omega-3, vitamin D3 and creatine monohydrate and Other : Physiotherapy treatment in people with Brain Injury Traumatic Mild, run by Universite de Moncton at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Brain Injury Traumatic Mild
- What is being tested?
- Experimental: Dietetic counseling, Active Comparator: Omega-3, vitamin D3 and creatine monohydrate and Other : Physiotherapy treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteCanada
- Study dates
- 1 Oct 2022to Jun 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- <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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Universite de Moncton
Moncton, New Brunswick, E1A 3E9
Stephanie Ward Chiasson, PhD, RD, 506-858-4000 ext. 4090, stephanie.ward@umoncton.ca
Horia-Daniel Iancu, PhD, 506-858-4000 ext. 4999, horia-daniel.iancu@umoncton.ca
About this study
Official title: 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
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.
Read the detailed description
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.
- Conditions
- Brain Injury Traumatic Mild
- Being tested
- Experimental: Dietetic counseling, Active Comparator: Omega-3, vitamin D3 and creatine monohydrate, Other : Physiotherapy treatment
- Keywords
- Dietary intervention, Supplements, Omega-3, Vitamin D, Creatine monohydrate
- Medical subject headings
- Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: Dietetic counselingBehavioural
Patients will receive dietary counselling to increase caloric and nutrient intake, stabilize glycemia, and optimize hydration.
Active Comparator: Omega-3, vitamin D3 and creatine monohydrateDietary supplement
Patients will be prescribed dietary supplements which will be taken daily for 8 weeks, as per the supplement protocol.
Other : Physiotherapy treatmentBehavioural
Patients will receive weekly physiotherapy treatment.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Experimental: Dietetic counseling; Dietary Supplement: Active Comparator: Omega-3, vitamin D3 and creatine monohydrate; Behavioral: Other : Physiotherapy treatment |
| 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. Receives: Dietary Supplement: Active Comparator: Omega-3, vitamin D3 and creatine monohydrate; Behavioral: Other : Physiotherapy treatment |
| Physiotherapy treatment (control group) | Other | Patients in the control group will receive physiotherapy treatments over eight weeks. Receives: Behavioral: Other : Physiotherapy treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline and Endpoint (Week 8)
Secondary outcomes (2)
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.
Measured: 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).
Measured: Baseline and Endpoint (Week 8)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2022
- Study start1 Oct 2022
- Primary completionJun 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (35)Papers the sponsor has linked to this study.
- Other trials for Brain Injury Traumatic MildStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universite de Moncton
- Sponsor type
- University, hospital or other
- Collaborators
- New Brunswick Health Research Foundation
- Responsible party
- Sponsor
- Investigators
- Stephanie Ward Chiasson, PhD, RD, Principal investigator, Universite de Moncton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05589064
- Sponsor's protocol ID
- 101616
- Status last verified
- Dec 2024
- First submitted
- 17 Oct 2022
- Last updated
- 13 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be made available to researchers upon reasonable request made to the principal investigator.
Publications
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.
PubMed 30202575Aminmansour 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.
PubMed 23326789Annweiler 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.
PubMed 27037788Baltazar 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.
PubMed 25642858Breck 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.
PubMed 31851345Carney N, Totten AM, O'Reilly C, Ullman JS, Hawryluk GW, Bell MJ, Bratton SL, Chesnut R, Harris OA, Kissoon N, Rubiano AM, Shutter L, Tasker RC, Vavilala MS, Wilberger J, Wright DW, Ghajar J. Guidelines for the Management of Severe Traumatic Brain Injury, Fourth Edition. Neurosurgery. 2017 Jan 1;80(1):6-15. doi: 10.1227/NEU.0000000000001432.
PubMed 27654000Cekic M, Cutler SM, VanLandingham JW, Stein DG. Vitamin D deficiency reduces the benefits of progesterone treatment after brain injury in aged rats. Neurobiol Aging. 2011 May;32(5):864-74. doi: 10.1016/j.neurobiolaging.2009.04.017. Epub 2009 May 30.
PubMed 19482377Cook AM, Peppard A, Magnuson B. Nutrition considerations in traumatic brain injury. Nutr Clin Pract. 2008 Dec-2009 Jan;23(6):608-20. doi: 10.1177/0884533608326060.
PubMed 19033220Curtis L, Epstein P. Nutritional treatment for acute and chronic traumatic brain injury patients. J Neurosurg Sci. 2014 Sep;58(3):151-60. Epub 2014 May 20.
PubMed 24844176Dolan 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.
PubMed 30086660Doroszkiewicz C, Gold D, Green R, Tartaglia MC, Ma J, Tator CH. Anxiety, Depression, and Quality of Life: A Long-Term Follow-Up Study of Patients with Persisting Concussion Symptoms. J Neurotrauma. 2021 Feb 15;38(4):493-505. doi: 10.1089/neu.2020.7313. Epub 2020 Nov 2.
PubMed 32962513Emanuelson I, Andersson Holmkvist E, Bjorklund R, Stalhammar D. Quality of life and post-concussion symptoms in adults after mild traumatic brain injury: a population-based study in western Sweden. Acta Neurol Scand. 2003 Nov;108(5):332-8. doi: 10.1034/j.1600-0404.2003.00155.x.
PubMed 14616303Giza CC, Hovda DA. The Neurometabolic Cascade of Concussion. J Athl Train. 2001 Sep;36(3):228-235.
PubMed 12937489Guskiewicz KM. Assessment of postural stability following sport-related concussion. Curr Sports Med Rep. 2003 Feb;2(1):24-30. doi: 10.1249/00149619-200302000-00006.
PubMed 12831673Heileson 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.
PubMed 34579748
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05589064
- Acronym / sponsor ID
- 101616
- Conditions
- Brain Injury Traumatic Mild
- Keywords
- Dietary intervention, Supplements, Omega-3, Vitamin D, Creatine monohydrate
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Universite de MonctonUniversity, hospital or other
- Collaborators
- New Brunswick Health Research Foundation
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 21 Oct 2022 (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.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dietary intervention and nutritional supplements (group A) | Experimental | Behavioral: Experimental: Dietetic counseling, Dietary Supplement: Active Comparator: Omega-3, vitamin D3 and creatine monohydrate, Behavioral: Other : Physiotherapy treatmentPatients 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 | Dietary Supplement: Active Comparator: Omega-3, vitamin D3 and creatine monohydrate, Behavioral: Other : Physiotherapy treatmentPatients 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 | Behavioral: Other : Physiotherapy treatmentPatients in the control group will receive physiotherapy treatments over eight weeks. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- <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
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 |
|---|---|---|
| Experimental: Dietetic counselingPatients will receive dietary counselling to increase caloric and nutrient intake, stabilize glycemia, and optimize hydration. | Behavioural | Dietary intervention and nutritional supplements (group A) |
| Active Comparator: Omega-3, vitamin D3 and creatine monohydratePatients will be prescribed dietary supplements which will be taken daily for 8 weeks, as per the supplement protocol. | Dietary supplement | Dietary intervention and nutritional supplements (group A), Nutritional supplements (group B) |
| Other : Physiotherapy treatmentPatients will receive weekly physiotherapy treatment. | Behavioural | Dietary intervention and nutritional supplements (group A), Nutritional supplements (group B), Physiotherapy treatment (control group) |
Primary outcome
Change from baseline in severity of post-concussive symptoms at the end of the intervention
Time frame: Baseline and Endpoint (Week 8)
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).
2 secondary outcomes
Change from baseline in balance at the end of the intervention
Time frame: Baseline and Endpoint (Week 8)
Change from baseline in vestibular ocular motor at the end of the intervention
Time frame: Baseline and Endpoint (Week 8)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2024.
- Background: PubMed 30202575Ainsley 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.
- Background: PubMed 23326789Aminmansour 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.
- Background: PubMed 27037788Annweiler 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.
- Background: PubMed 25642858Baltazar 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.
- Background: PubMed 31851345Breck 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.
- Background: PubMed 27654000Carney N, Totten AM, O'Reilly C, Ullman JS, Hawryluk GW, Bell MJ, Bratton SL, Chesnut R, Harris OA, Kissoon N, Rubiano AM, Shutter L, Tasker RC, Vavilala MS, Wilberger J, Wright DW, Ghajar J. Guidelines for the Management of Severe Traumatic Brain Injury, Fourth Edition. Neurosurgery. 2017 Jan 1;80(1):6-15. doi: 10.1227/NEU.0000000000001432.
- Background: PubMed 19482377Cekic M, Cutler SM, VanLandingham JW, Stein DG. Vitamin D deficiency reduces the benefits of progesterone treatment after brain injury in aged rats. Neurobiol Aging. 2011 May;32(5):864-74. doi: 10.1016/j.neurobiolaging.2009.04.017. Epub 2009 May 30.
- Background: PubMed 19033220Cook AM, Peppard A, Magnuson B. Nutrition considerations in traumatic brain injury. Nutr Clin Pract. 2008 Dec-2009 Jan;23(6):608-20. doi: 10.1177/0884533608326060.
- Background: PubMed 24844176Curtis L, Epstein P. Nutritional treatment for acute and chronic traumatic brain injury patients. J Neurosurg Sci. 2014 Sep;58(3):151-60. Epub 2014 May 20.
- Background: PubMed 30086660Dolan 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.
- Background: PubMed 32962513Doroszkiewicz C, Gold D, Green R, Tartaglia MC, Ma J, Tator CH. Anxiety, Depression, and Quality of Life: A Long-Term Follow-Up Study of Patients with Persisting Concussion Symptoms. J Neurotrauma. 2021 Feb 15;38(4):493-505. doi: 10.1089/neu.2020.7313. Epub 2020 Nov 2.
- Background: PubMed 14616303Emanuelson I, Andersson Holmkvist E, Bjorklund R, Stalhammar D. Quality of life and post-concussion symptoms in adults after mild traumatic brain injury: a population-based study in western Sweden. Acta Neurol Scand. 2003 Nov;108(5):332-8. doi: 10.1034/j.1600-0404.2003.00155.x.
- Individual participant dataSharing planned: No. Data will be made available to researchers upon reasonable request made to the principal investigator.
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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.
Stephanie Ward Chiasson, PhD, RD principal investigator
Universite de Moncton
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental: Dietetic counseling, Active Comparator: Omega-3, vitamin D3 and creatine monohydrate and Other : Physiotherapy treatment in people with Brain Injury Traumatic Mild, run by Universite de Moncton 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 5 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: looking for participants now, as of the sponsor's last update on 13 Dec 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stephanie Ward Chiasson, PhD, RD (506-858-4000 ext. 4090, stephanie.ward@umoncton.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in severity of post-concussive symptoms at the end of the intervention (time frame: Baseline and Endpoint (Week 8)). 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 NCT05589064, which also lists 35 linked publications.
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 13 Dec 2024.