NCT05593172

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 24, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 3, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 3, 2016

Completed
6.4 years until next milestone

First Submitted

Initial submission to the registry

October 10, 2022

Completed
15 days until next milestone

First Posted

Study publicly available on registry

October 25, 2022

Completed
Last Updated

October 25, 2022

Status Verified

October 1, 2022

Enrollment Period

1.3 years

First QC Date

October 10, 2022

Last Update Submit

October 21, 2022

Conditions

Mild Traumatic Brain Injury

Keywords

rs-fMRICognitive reserveFatigueVisual disturbances

Outcome Measures

Primary Outcomes (4)

  • 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 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 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 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 at approximately 4 months after injury

Secondary Outcomes (12)

  • Trait fatigability

    Measured at approximately one week after injury

  • Trait fatigability

    Measured at approximately 4 months after injury

  • Anxiety and depression

    Measured at approximately one week after injury

  • Anxiety and depression

    Measured at approximately 4 months after injury

  • Self-rated visual symptoms in near work

    Measured at approximately one week after injury

  • +7 more secondary outcomes

Study Arms (2)

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

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Rehabilitation Medicine, Danderyd Hospital

Stockholm, 18288, Sweden

Location

Related Publications (10)

  • 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.

    PMID: 15083870BACKGROUND

  • McInnes 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.

    PMID: 28399158BACKGROUND

  • Puig 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.

    PMID: 32228145BACKGROUND

  • Madhavan 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.

    PMID: 30024343BACKGROUND

  • Palacios 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.

    PMID: 28085565BACKGROUND

  • Jones 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.

    PMID: 21411036BACKGROUND

  • Nelson 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.

    PMID: 33415533BACKGROUND

  • Sumowski 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.

    PMID: 24748670BACKGROUND

  • Oldenburg 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.

    PMID: 26618716BACKGROUND

  • Ekdahl 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.

    PMID: 38124076DERIVED

MeSH Terms

Conditions

Brain ConcussionFatigue

Condition Hierarchy (Ancestors)

Brain Injuries, TraumaticBrain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemHead Injuries, ClosedWounds and InjuriesWounds, NonpenetratingSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Marika C Moller, PhD

    Departement of Rehabilitation Medicine, Danderyd Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 10, 2022

First Posted

October 25, 2022

Study Start

January 24, 2015

Primary Completion

May 3, 2016

Study Completion

May 3, 2016

Last Updated

October 25, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)