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Completed

NCT Number: NCT05593172

Change in Connectivity After mTBI Depending on Cognitive Reserve

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

mTBI group:

  • 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

Inclusion criteria

orthopedic group:

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Secondary outcomes

  1. Trait fatigability

    Time frame: Measured at approximately one week after injury

    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.

  2. Trait fatigability

    Time frame: Measured at approximately 4 months after injury

    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.

  3. Anxiety and depression

    Time frame: Measured at approximately one week after injury

    Hospital Anxiety and Depression (HADS) scale was used to screen for depression and anxiety, range (0-42) higher scores indicate more severe problems

  4. Anxiety and depression

    Time frame: Measured at approximately 4 months after injury

    Hospital Anxiety and Depression (HADS) scale was used to screen for depression and anxiety, range (0-42) higher scores indicate more severe problems

  5. Self-rated visual symptoms in near work

    Time frame: Measured at approximately one week after injury

    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.

  6. Self-rated visual symptoms in near work

    Time frame: Measured at approximately 4 months after injury

    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.

  7. Convergence

    Time frame: Measured at approximately one week after injury

    A visual examination performed by a licensed optometrist, using standard optometric clinical methods. Diagnosis of visual dysfunction were based on established diagnostic criteria

  8. Convergence

    Time frame: Measured at approximately 4 months after injury

    A visual examination performed by a licensed optometrist, using standard optometric clinical methods. Diagnosis of visual dysfunction were based on established diagnostic criteria

  9. Accommodation

    Time frame: Measured at approximately one week after injury

    A visual examination performed by a licensed optometrist, using standard optometric clinical methods. Diagnosis of visual dysfunction were based on established diagnostic criteria

  10. Accommodation

    Time frame: Measured at approximately 4 months after injury

    A visual examination performed by a licensed optometrist, using standard optometric clinical methods. Diagnosis of visual dysfunction were based on established diagnostic criteria

  11. Fusional vergence

    Time frame: Measured at approximately one week after injury

    A visual examination performed by a licensed optometrist, using standard optometric clinical methods. Diagnosis of visual dysfunction were based on established diagnostic criteria

  12. Fusional vergence

    Time frame: Measured at approximately 4 months after injury

    A visual examination performed by a licensed optometrist, using standard optometric clinical methods. Diagnosis of visual dysfunction were based on established diagnostic criteria

Sponsors and collaborators

Lead sponsor

Danderyd Hospital

Other

Registry information

Official study title

Different Courses of Change in Connectivity After mTBI Depending on Cognitive Reserve and How This is Related to Symptoms and Symptom Resolution?

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Oct 25, 2022
Registry last updated
Oct 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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