Clinical trial NCT03727334: Offsetting Hippocampal Degeneration in m-sTBI
Official title: Offsetting Hippocampal Degeneration in Moderate to Severe TBI
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Traumatic Brain Injury
Degeneration
Memory; Loss, Mild, Following Organic Brain Damage
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: University Health Network, Toronto
First posted: 2018-11-01
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a randomized two-armed study, comprised of a treatment arm and a control arm. Given the small numbers and the potentially slow rate of recruitment, the investigators will employ simple rather than block randomization. To minimize selection bias, allocation to group will be concealed (i.e., with assignment unpredictable and unchangeable) using software that randomizes each patient upon confirmation of eligibility. Patients will not be blind to group assignment, but the psychometrist completing behavioural outcomes will be kept blind to group assignment.
Primary purpose: TREATMENT

Brief summary: The goal of this study is to establish the feasibility of an intervention designed to improve memory in patients who have experienced a moderate or severe traumatic brain injury (m-sTBI) and to examine its effect on brain structures.

Detailed description: The purpose of this study is to establish the feasibility of a novel intervention, and explore biomarker predictors of neurodegeneration and response to the proposed intervention. This 16 week intervention utilises allocentric spatial navigation tasks to improve memory and counteract hippocampal neurodegeneration. This intervention will be administered in combination with neuropsychological assessments, MR imaging, and the analysis of genomic variants at two time points; 7 months post-TBI and 12 months post-TBI.

Eligibility criteria: Inclusion Criteria:

* An acute care diagnosis of TBI as determined by a medical professional, indicated by:

  * Post-traumatic amnesia duration of 24 hours or more, and/or lowest Glasgow Coma Scale score of \< 13
  * Positive clinical CT or MRI scan
* Aged 18 to 65
* Fluent in English
* Have the competency for fully informed consent by 6 months post-injury
* Have basic computer skills
* Have functional use of one upper extremity
* Have access to the internet

Exclusion Criteria:

* A neurological disorder other than TBI (e.g., stroke, dementia, tumor, neurodevelopmental disorder) impairing baseline awareness, cognition, or validity of follow-up and outcome assessment.
* A systemic condition (e.g., lupus, diabetes, rheumatoid arthritis).
* Any contraindications to magnetic resonance imaging (MRI)
* You are experiencing language impairments (i.e., aphasia) from your injury

Primary outcomes:
measure: Online Spatial Navigation Intervention Test Scores: Change in Spatial Learning Ability
timeFrame: Time-point 1: 7 months post-injury and Time-point 2: 12 months post-injury
measure: Online Spatial Navigation Intervention Test Scores: Change in Cognitive Map Formation
timeFrame: Time-point 1: 7 months post-injury and Time-point 2: 12 months post-injury
measure: Online Spatial Navigation Intervention Test Scores: Change in Pattern Separation
timeFrame: Time-point 1: 7 months post-injury and Time-point 2: 12 months post-injury
measure: Online Spatial Navigation Intervention Test Scores: Change in Pattern Completion
timeFrame: Time-point 1: 7 months post-injury and Time-point 2: 12 months post-injury
Secondary outcomes:
measure: Neuronal injury biomarker predictors in serum and plasma samples
timeFrame: Time-point 1: 7 months post-injury and Time-point 2: 12 months post-injury
measure: Gliosis and inflammation biomarker predictors in serum samples
timeFrame: Time-point 1: 7 months post-injury and Time-point 2: 12 months post-injury
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Vancouver General Hopsital
state: British Columbia
city: Vancouver
country: Canada
facility: GF Strong Rehabilitation Centre
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: William Panenka, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Health Network, Toronto
name: Robin Green, PhD
role: PRINCIPAL_INVESTIGATOR
References: