Microstructural Changes in the Brain During Recovery After Mild Traumatic Brain Injury

NCT02350894 | Completed DMC

• 1 other identifier: 1-10-72-139-14
• Study Type: observational
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

This study examines the possible microstructural changes in the brain during recovery after mTBI using diffusion MRI.

Conditions

Brain Concussion

Outcome Measures

Primary Outcomes (1)

• Microstructural changes in the thalamus, corpus callosum and hippocampus between baseline and follow up, as measured by Diffusion kurtosis imaging (DKI)

  MRI measurement

  Baseline 2-6 month after mTBI with follow up 6 month after

Secondary Outcomes (3)

• Microstructural changes in the thalamus, corpus callosum and hippocampus from baseline to follow up, as measured by Diffusion tensor imaging (DTI)

  Baseline 2-6 month after mTBI with follow up 6 month after

• Change in post-concussion symptoms from baseline to follow up, as measured by Rivermead post-concussion questionnaire (RPQ) and headache (VAS scale)

  Baseline 2-6 month after mTBI with follow up 6 month after

• Change in Cognitive performance from baseline to follow up, as measured by executive function, verbal and visual memory, processing speed, working memory, Visuospatial perception and construction

  Baseline 2-6 month after mTBI with follow up 6 month after

Study Arms (1)

mTBI subjects

mTBI subjects with ongoing symptoms

Behavioral: Graded and behavevial theraphy

Interventions

Graded and behavevial theraphy BEHAVIORAL

Graded and behavevial theraphy

mTBI subjects

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Mild traumatic brain injury subjects with ongoing symptoms 2-6 months after trauma

You may qualify if:

• Concussion caused by a head trauma according to the diagnostic criteria recommended by the Danish Consensus Report on Commotio Cerebri within the last 2-6 months. The criteria are based on recommendations by the WHO Task Force, but with the amendment, that there must have been a direct contact between the head and an object in order to rule out pure acceleration - deceleration traumas.
• Age 18 to 30 years at the time of the head trauma.
• Able to understand, speak and read Danish.
• Patients with symptoms on at least three items on the Rivermead Post Concussion Symptoms Questionnaire (RPQ) rated as moderate or severe problem. PCS have to be subjectively rated as causing substantial impairment in daily life.
• Suitable for MRI examination

You may not qualify if:

• Objective neurological findings from neurological examination and / or acute trauma CT scan, indicating other neurological diseases or brain damage.
• Previous concussion leading to persistent PCS within the last two years.
• Severe abuse of alcohol, prescription drugs and / or illegal drugs.
• Psychiatric morbidity or severe neurological disease that impedes participation in the treatment, i.e. Bipolar Disorder, autism, psychotic disorder (lifetime), multiple sclerosis etc.

Sponsors & Collaborators

• University of Aarhus: lead
• Regionshospitalet Hammel Neurocenter: collaborator
• Aarhus University Hospital: collaborator

Study Sites (1)

Region Hospital Hammel Neurocenter

Hammel, 8450, Denmark

Location

Related Publications (1)

• Trillingsgaard Naess-Schmidt E, Udby Blicher J, Moller Thastum M, Ulrikka Rask C, Wulff Svendsen S, Schroder A, Hogh Tuborgh A, Ostergaard L, Sangill R, Lund T, Norhoj Jespersen S, Roer Pedersen A, Hansen B, Fristed Eskildsen S, Feldbaek Nielsen J. Microstructural changes in the brain after long-term post-concussion symptoms: A randomized trial. J Neurosci Res. 2021 Mar;99(3):872-886. doi: 10.1002/jnr.24773. Epub 2020 Dec 15.

  PMID: 33319932 DERIVED

Related Links

• The Research Clinic for Functional Disorders and Psychosomatics, Aarhus University Hospital
• Center of Functionally Integrative Neuroscience, Aarhus University, Aarhus University Hospital

MeSH Terms

Conditions

Brain Concussion

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Study Officials

• Jørgen F Nielsen, Professor

  Hammel Neurocenter - Universitetsklinik for Neurorehabilitering, Aarhus Universi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2015
• First Posted: January 30, 2015
• Study Start: January 1, 2015
• Primary Completion: February 1, 2018
• Study Completion: May 1, 2018
• Last Updated: May 24, 2018

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)