Mild Traumatic Brain InjuryNCT05593172
Change in Connectivity After mTBI Depending on Cognitive Reserve
An observational study of Mild Traumatic Brain Injury, run by Danderyd Hospital at 1 site in Sweden.
Trial summary
The purpose of this study is to investigate the role of cognitive reserve in change in connectivity in the brain (measured with functional magnetic resonance imaging, fMRI) and how this is related to symptoms and symptom resolution. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Mild Traumatic Brain Injury
- How many people
- 30 participants
- Where
- 1 siteSweden
- Study dates
- 24 Jan 2015to 3 May 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Study population: Participants were all adults presenting at the emergency departement at Danderyd Hospital, (Stockholm, Sweden) during the given time frame, with minor head injury or minor orthopedic injury. An upper age limit of 40 years were set due to avoiding interference with age-related visual disturbances.
Who may be able to join
- presenting at the emergency departement between January 2015 and April 2016 due to an mTBI to such an extent that CT was indicated.
- mTBI was defined by a Glasgow Coma Scale score between 13-15 and one or more of the following symptoms: <30 minutes loss of consciousness, <24 hours post-traumatic amnesia and/or a transient neurological deficit according to the WHO Collaborating center of Neurotrauma Task Force
- presenting at the emergency departement between January 2015 and April 2016 due to minor traumatic injuries to the hand, foot, arm or leg that did not require surgical intervention.
Who cannot join
- uncertain duration of loss of consciousness
- contraindications to MR
- previously acquired brain injury, a progressive neurological disorder or another injury/illness with short expected survival
- were dependent of help in daily living before the current damage
- severe visual impairment
- non-Swedish speaking.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department of Rehabilitation Medicine, Danderyd Hospital
Stockholm, 18288
About this study
Official title: Different Courses of Change in Connectivity After mTBI Depending on Cognitive Reserve and How This is Related to Symptoms and Symptom Resolution?
The purpose of this study is to investigate the role of cognitive reserve in change in connectivity in the brain (measured with functional magnetic resonance imaging, fMRI) and how this is related to symptoms and symptom resolution.
Read the detailed description
The population-based rate of mild traumatic brain injury (mTBI) is estimated to exceed 600/100000 population per year in total, if including only patients seeking emergency care the estimated rate is approximately 100-300/100000. Many patients recover within 3 months after injury but a sustainable proportion suffer from persisting symptoms, for instance fatigue, headaches, irritability. As conventional neuroimaging techniques have failed to detect the subtle alterations that may be important for prognosis and long-term outcome after mTBI, studies using fMRI have shown some interesting results. Other variables, for instance demographic and cognitive variables, also need to be incorporated with imaging biomarkers when investigating the relationship between fMRI biomarkers with outcome after mTBI. A marker related to demographic status and cognition that have shown to be relevant for outcome in brain injury or pathology is cognitive reserve. Cognitive reserve is defined as an aspect of the brain's function or structure that impacts the relationship between injury/pathology and outcome. Higher cognitive reserve is related to better outcome in conditions ranging from Alzheimer, MS and mTBI.
In this study 15 patients with mTBI and 15 patients with minor orthopedic injury underwent assessment, including cognitive testing, self-assessment of symptoms, testing of visual functions and resting-state fMRI at approximately one week after injury and 4 months after injury. Cognitive reserve was assessed with a lexical decision test designed to measure pre-morbid IQ.
Descriptive statistics will be used to depict demographics, injury characteristics, results on neuropsychological tests and psychological screening instruments. Multi-subject and multi-session analysis based on general linear model will be performed and assessed using statistical tools including regression analysis and 2-way ANOVA.
- Conditions
- Mild Traumatic Brain Injury
- Keywords
- rs-fMRI, Cognitive reserve, Fatigue, Visual disturbances
- Medical subject headings
- Brain Concussion, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Mild traumatic brain injury | 15 consecutive patients presenting at the emergency departement with mild traumatic brain injury | |
| Minor orthopedic injury | 15 patients, recruited during the same time-frame as the mTBI-patients, presenting at the emergency departement with a minor orthopedic injury |
What is being measured
The primary outcome is the main question the study is designed to answer.
State fatigability
Difference between score during the first 60 and the last 60 seconds of the Digit Symbol Substitution Test/Coding (DSST). The lower the score, the stronger the indication of fatigability
Measured: Measured at approximately one week after injury
State fatigability
Difference between score during the first 60 and the last 60 seconds of the Digit Symbol Substitution Test/Coding (DSST). The lower the score, the stronger the indication of fatigability
Measured: Measured at approximately 4 months after injury
Self rated post-concussion symptoms
For assessment of self-rated symptoms The Rivermead Post-Concussion Symptoms Questionnaire (RPQ) was used. RPQ is based on a Likert scale and includes 16 items with ratings from 0 to 4. Higher score indicates more symptoms
Measured: Measured at approximately one week after injury
Self rated post-concussion symptoms
For assessment of self-rated symptoms The Rivermead Post-Concussion Symptoms Questionnaire (RPQ) was used. RPQ is based on a Likert scale and includes 16 items with ratings from 0 to 4. Higher score indicates more symptoms
Measured: Measured at approximately 4 months after injury
Secondary outcomes (12)
Trait fatigability
The Fatigue Severity Scale (FSS) was used to measure trait fatigue. FSS consists of 9 questions and is based on a 7 point Likert scale A high score implies a higher level of fatigue.
Measured: Measured at approximately one week after injury
Trait fatigability
The Fatigue Severity Scale (FSS) was used to measure trait fatigue. FSS consists of 9 questions and is based on a 7 point Likert scale A high score implies a higher level of fatigue.
Measured: Measured at approximately 4 months after injury
Anxiety and depression
Hospital Anxiety and Depression (HADS) scale was used to screen for depression and anxiety, range (0-42) higher scores indicate more severe problems
Measured: Measured at approximately one week after injury
Anxiety and depression
Hospital Anxiety and Depression (HADS) scale was used to screen for depression and anxiety, range (0-42) higher scores indicate more severe problems
Measured: Measured at approximately 4 months after injury
Self-rated visual symptoms in near work
Convergence Insufficiency Symptom Survey (CISS) was used to assess near work-related visual symptoms. Total score is 60 and a value above 21 indicates a high level of symptoms.
Measured: Measured at approximately one week after injury
Self-rated visual symptoms in near work
Convergence Insufficiency Symptom Survey (CISS) was used to assess near work-related visual symptoms. Total score is 60 and a value above 21 indicates a high level of symptoms.
Measured: Measured at approximately 4 months after injury
Convergence
A visual examination performed by a licensed optometrist, using standard optometric clinical methods. Diagnosis of visual dysfunction were based on established diagnostic criteria
Measured: Measured at approximately one week after injury
Convergence
A visual examination performed by a licensed optometrist, using standard optometric clinical methods. Diagnosis of visual dysfunction were based on established diagnostic criteria
Measured: Measured at approximately 4 months after injury
Accommodation
A visual examination performed by a licensed optometrist, using standard optometric clinical methods. Diagnosis of visual dysfunction were based on established diagnostic criteria
Measured: Measured at approximately one week after injury
Accommodation
A visual examination performed by a licensed optometrist, using standard optometric clinical methods. Diagnosis of visual dysfunction were based on established diagnostic criteria
Measured: Measured at approximately 4 months after injury
Fusional vergence
A visual examination performed by a licensed optometrist, using standard optometric clinical methods. Diagnosis of visual dysfunction were based on established diagnostic criteria
Measured: Measured at approximately one week after injury
Fusional vergence
A visual examination performed by a licensed optometrist, using standard optometric clinical methods. Diagnosis of visual dysfunction were based on established diagnostic criteria
Measured: Measured at approximately 4 months after injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2022
- Study start24 Jan 2015
- Primary completion3 May 2016
- Study completion3 May 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Mild Traumatic Brain InjuryStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danderyd Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marika C Moller, PhD, Principal investigator, Departement of Rehabilitation Medicine, Danderyd Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05593172
- Sponsor's protocol ID
- fMRICogRev
- Status last verified
- Oct 2022
- First submitted
- 10 Oct 2022
- Last updated
- 25 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cassidy JD, Carroll LJ, Peloso PM, Borg J, von Holst H, Holm L, Kraus J, Coronado VG; WHO Collaborating Centre Task Force on Mild Traumatic Brain Injury. Incidence, risk factors and prevention of mild traumatic brain injury: results of the WHO Collaborating Centre Task Force on Mild Traumatic Brain Injury. J Rehabil Med. 2004 Feb;(43 Suppl):28-60. doi: 10.1080/16501960410023732.
PubMed 15083870McInnes K, Friesen CL, MacKenzie DE, Westwood DA, Boe SG. Mild Traumatic Brain Injury (mTBI) and chronic cognitive impairment: A scoping review. PLoS One. 2017 Apr 11;12(4):e0174847. doi: 10.1371/journal.pone.0174847. eCollection 2017.
PubMed 28399158Puig J, Ellis MJ, Kornelsen J, Figley TD, Figley CR, Daunis-I-Estadella P, Mutch WAC, Essig M. Magnetic Resonance Imaging Biomarkers of Brain Connectivity in Predicting Outcome after Mild Traumatic Brain Injury: A Systematic Review. J Neurotrauma. 2020 Aug 15;37(16):1761-1776. doi: 10.1089/neu.2019.6623. Epub 2020 Apr 24.
PubMed 32228145Madhavan R, Joel SE, Mullick R, Cogsil T, Niogi SN, Tsiouris AJ, Mukherjee P, Masdeu JC, Marinelli L, Shetty T. Longitudinal Resting State Functional Connectivity Predicts Clinical Outcome in Mild Traumatic Brain Injury. J Neurotrauma. 2019 Mar 1;36(5):650-660. doi: 10.1089/neu.2018.5739. Epub 2018 Oct 3.
PubMed 30024343Palacios EM, Yuh EL, Chang YS, Yue JK, Schnyer DM, Okonkwo DO, Valadka AB, Gordon WA, Maas AIR, Vassar M, Manley GT, Mukherjee P. Resting-State Functional Connectivity Alterations Associated with Six-Month Outcomes in Mild Traumatic Brain Injury. J Neurotrauma. 2017 Apr 15;34(8):1546-1557. doi: 10.1089/neu.2016.4752. Epub 2017 Jan 13.
PubMed 28085565Jones RN, Manly J, Glymour MM, Rentz DM, Jefferson AL, Stern Y. Conceptual and measurement challenges in research on cognitive reserve. J Int Neuropsychol Soc. 2011 Jul;17(4):593-601. doi: 10.1017/S1355617710001748.
PubMed 21411036Nelson ME, Jester DJ, Petkus AJ, Andel R. Cognitive Reserve, Alzheimer's Neuropathology, and Risk of Dementia: A Systematic Review and Meta-Analysis. Neuropsychol Rev. 2021 Jun;31(2):233-250. doi: 10.1007/s11065-021-09478-4. Epub 2021 Jan 8.
PubMed 33415533Sumowski JF, Rocca MA, Leavitt VM, Dackovic J, Mesaros S, Drulovic J, DeLuca J, Filippi M. Brain reserve and cognitive reserve protect against cognitive decline over 4.5 years in MS. Neurology. 2014 May 20;82(20):1776-83. doi: 10.1212/WNL.0000000000000433. Epub 2014 Apr 18.
PubMed 24748670Oldenburg C, Lundin A, Edman G, Nygren-de Boussard C, Bartfai A. Cognitive reserve and persistent post-concussion symptoms--A prospective mild traumatic brain injury (mTBI) cohort study. Brain Inj. 2016;30(2):146-55. doi: 10.3109/02699052.2015.1089598. Epub 2015 Nov 30.
PubMed 26618716Ekdahl N, Moller MC, Deboussard CN, Stalnacke BM, Lannsjo M, Nordin LE. Investigating cognitive reserve, symptom resolution and brain connectivity in mild traumatic brain injury. BMC Neurol. 2023 Dec 20;23(1):450. doi: 10.1186/s12883-023-03509-8.
PubMed 38124076
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Different Courses of Change in Connectivity After mTBI Depending on Cognitive Reserve and How This is Related to Symptoms and Symptom Resolution?
- ClinicalTrials.gov ID
- NCT05593172
- Acronym / sponsor ID
- fMRICogRev
- Conditions
- Mild Traumatic Brain Injury
- Keywords
- rs-fMRI, Cognitive reserve, Fatigue, Visual disturbances
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Danderyd HospitalUniversity, hospital or other
- Study start
- 24 Jan 2015 (actual)
- Primary completion
- 3 May 2016 (actual)
- Study completion
- 3 May 2016 (actual)
- First posted
- 25 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.
The purpose of this study is to investigate the role of cognitive reserve in change in connectivity in the brain (measured with functional magnetic resonance imaging, fMRI) and how this is related to symptoms and symptom resolution.
Detailed description
The population-based rate of mild traumatic brain injury (mTBI) is estimated to exceed 600/100000 population per year in total, if including only patients seeking emergency care the estimated rate is approximately 100-300/100000. Many patients recover within 3 months after injury but a sustainable proportion suffer from persisting symptoms, for instance fatigue, headaches, irritability. As conventional neuroimaging techniques have failed to detect the subtle alterations that may be important for prognosis and long-term outcome after mTBI, studies using fMRI have shown some interesting results. Other variables, for instance demographic and cognitive variables, also need to be incorporated with imaging biomarkers when investigating the relationship between fMRI biomarkers with outcome after mTBI. A marker related to demographic status and cognition that have shown to be relevant for outcome in brain injury or pathology is cognitive reserve. Cognitive reserve is defined as an aspect of the brain's function or structure that impacts the relationship between injury/pathology and outcome. Higher cognitive reserve is related to better outcome in conditions ranging from Alzheimer, MS and mTBI.
In this study 15 patients with mTBI and 15 patients with minor orthopedic injury underwent assessment, including cognitive testing, self-assessment of symptoms, testing of visual functions and resting-state fMRI at approximately one week after injury and 4 months after injury. Cognitive reserve was assessed with a lexical decision test designed to measure pre-morbid IQ.
Descriptive statistics will be used to depict demographics, injury characteristics, results on neuropsychological tests and psychological screening instruments. Multi-subject and multi-session analysis based on general linear model will be performed and assessed using statistical tools including regression analysis and 2-way ANOVA.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mild traumatic brain injury | – | –15 consecutive patients presenting at the emergency departement with mild traumatic brain injury |
| Minor orthopedic injury | – | –15 patients, recruited during the same time-frame as the mTBI-patients, presenting at the emergency departement with a minor orthopedic injury |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Participants were all adults presenting at the emergency departement at Danderyd Hospital, (Stockholm, Sweden) during the given time frame, with minor head injury or minor orthopedic injury. An upper age limit of 40 years were set due to avoiding interference with age-related visual disturbances.
Key inclusion criteria (3 listed)
- presenting at the emergency departement between January 2015 and April 2016 due to an mTBI to such an extent that CT was indicated.
- mTBI was defined by a Glasgow Coma Scale score between 13-15 and one or more of the following symptoms: <30 minutes loss of consciousness, <24 hours post-traumatic amnesia and/or a transient neurological deficit according to the WHO Collaborating center of Neurotrauma Task Force
- presenting at the emergency departement between January 2015 and April 2016 due to minor traumatic injuries to the hand, foot, arm or leg that did not require surgical intervention.
Key exclusion criteria (6 listed)
- uncertain duration of loss of consciousness
- contraindications to MR
- previously acquired brain injury, a progressive neurological disorder or another injury/illness with short expected survival
- were dependent of help in daily living before the current damage
- severe visual impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
State fatigability
Time frame: Measured at approximately one week after injury
Difference between score during the first 60 and the last 60 seconds of the Digit Symbol Substitution Test/Coding (DSST). The lower the score, the stronger the indication of fatigability
State fatigability
Time frame: Measured at approximately 4 months after injury
Difference between score during the first 60 and the last 60 seconds of the Digit Symbol Substitution Test/Coding (DSST). The lower the score, the stronger the indication of fatigability
Self rated post-concussion symptoms
Time frame: Measured at approximately one week after injury
For assessment of self-rated symptoms The Rivermead Post-Concussion Symptoms Questionnaire (RPQ) was used. RPQ is based on a Likert scale and includes 16 items with ratings from 0 to 4. Higher score indicates more symptoms
Self rated post-concussion symptoms
Time frame: Measured at approximately 4 months after injury
For assessment of self-rated symptoms The Rivermead Post-Concussion Symptoms Questionnaire (RPQ) was used. RPQ is based on a Likert scale and includes 16 items with ratings from 0 to 4. Higher score indicates more symptoms
12 secondary outcomes
Trait fatigability
Time frame: Measured at approximately one week after injury
Trait fatigability
Time frame: Measured at approximately 4 months after injury
Anxiety and depression
Time frame: Measured at approximately one week after injury
Anxiety and depression
Time frame: Measured at approximately 4 months after injury
Self-rated visual symptoms in near work
Time frame: Measured at approximately one week after injury
Self-rated visual symptoms in near work
Time frame: Measured at approximately 4 months after injury
Convergence
Time frame: Measured at approximately one week after injury
Convergence
Time frame: Measured at approximately 4 months after injury
Accommodation
Time frame: Measured at approximately one week after injury
Accommodation
Time frame: Measured at approximately 4 months after injury
Fusional vergence
Time frame: Measured at approximately one week after injury
Fusional vergence
Time frame: Measured at approximately 4 months after injury
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2022.
- Background: PubMed 15083870Cassidy JD, Carroll LJ, Peloso PM, Borg J, von Holst H, Holm L, Kraus J, Coronado VG; WHO Collaborating Centre Task Force on Mild Traumatic Brain Injury. Incidence, risk factors and prevention of mild traumatic brain injury: results of the WHO Collaborating Centre Task Force on Mild Traumatic Brain Injury. J Rehabil Med. 2004 Feb;(43 Suppl):28-60. doi: 10.1080/16501960410023732.
- Background: PubMed 28399158McInnes K, Friesen CL, MacKenzie DE, Westwood DA, Boe SG. Mild Traumatic Brain Injury (mTBI) and chronic cognitive impairment: A scoping review. PLoS One. 2017 Apr 11;12(4):e0174847. doi: 10.1371/journal.pone.0174847. eCollection 2017.
- Background: PubMed 32228145Puig J, Ellis MJ, Kornelsen J, Figley TD, Figley CR, Daunis-I-Estadella P, Mutch WAC, Essig M. Magnetic Resonance Imaging Biomarkers of Brain Connectivity in Predicting Outcome after Mild Traumatic Brain Injury: A Systematic Review. J Neurotrauma. 2020 Aug 15;37(16):1761-1776. doi: 10.1089/neu.2019.6623. Epub 2020 Apr 24.
- Background: PubMed 30024343Madhavan R, Joel SE, Mullick R, Cogsil T, Niogi SN, Tsiouris AJ, Mukherjee P, Masdeu JC, Marinelli L, Shetty T. Longitudinal Resting State Functional Connectivity Predicts Clinical Outcome in Mild Traumatic Brain Injury. J Neurotrauma. 2019 Mar 1;36(5):650-660. doi: 10.1089/neu.2018.5739. Epub 2018 Oct 3.
- Background: PubMed 28085565Palacios EM, Yuh EL, Chang YS, Yue JK, Schnyer DM, Okonkwo DO, Valadka AB, Gordon WA, Maas AIR, Vassar M, Manley GT, Mukherjee P. Resting-State Functional Connectivity Alterations Associated with Six-Month Outcomes in Mild Traumatic Brain Injury. J Neurotrauma. 2017 Apr 15;34(8):1546-1557. doi: 10.1089/neu.2016.4752. Epub 2017 Jan 13.
- Background: PubMed 21411036Jones RN, Manly J, Glymour MM, Rentz DM, Jefferson AL, Stern Y. Conceptual and measurement challenges in research on cognitive reserve. J Int Neuropsychol Soc. 2011 Jul;17(4):593-601. doi: 10.1017/S1355617710001748.
- Background: PubMed 33415533Nelson ME, Jester DJ, Petkus AJ, Andel R. Cognitive Reserve, Alzheimer's Neuropathology, and Risk of Dementia: A Systematic Review and Meta-Analysis. Neuropsychol Rev. 2021 Jun;31(2):233-250. doi: 10.1007/s11065-021-09478-4. Epub 2021 Jan 8.
- Background: PubMed 24748670Sumowski JF, Rocca MA, Leavitt VM, Dackovic J, Mesaros S, Drulovic J, DeLuca J, Filippi M. Brain reserve and cognitive reserve protect against cognitive decline over 4.5 years in MS. Neurology. 2014 May 20;82(20):1776-83. doi: 10.1212/WNL.0000000000000433. Epub 2014 Apr 18.
- Background: PubMed 26618716Oldenburg C, Lundin A, Edman G, Nygren-de Boussard C, Bartfai A. Cognitive reserve and persistent post-concussion symptoms--A prospective mild traumatic brain injury (mTBI) cohort study. Brain Inj. 2016;30(2):146-55. doi: 10.3109/02699052.2015.1089598. Epub 2015 Nov 30.
- Derived from this study: PubMed 38124076Ekdahl N, Moller MC, Deboussard CN, Stalnacke BM, Lannsjo M, Nordin LE. Investigating cognitive reserve, symptom resolution and brain connectivity in mild traumatic brain injury. BMC Neurol. 2023 Dec 20;23(1):450. doi: 10.1186/s12883-023-03509-8.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Marika C Moller, PhD principal investigator
Departement of Rehabilitation Medicine, Danderyd Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mild Traumatic Brain Injury, run by Danderyd Hospital at 1 site in Sweden.
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 6 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: finished, as of the sponsor's last update on 25 Oct 2022. 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 Sweden. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
State fatigability (time frame: Measured at approximately one week after injury). The study lists 4 primary outcomes in all. 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 NCT05593172, which also lists 10 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 25 Oct 2022.