Offsetting Hippocampal Degeneration in m-sTBI (m-sTBI)
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|ClinicalTrials.gov Identifier: NCT03727334|
Recruitment Status : Recruiting
First Posted : November 1, 2018
Last Update Posted : September 2, 2019
|Condition or disease||Intervention/treatment||Phase|
|Traumatic Brain Injury Degeneration Memory; Loss, Mild, Following Organic Brain Damage||Behavioral: Online Spatial Navigation Training||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Parallel Assignment|
|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.|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||The psychometrist will be blind to the arm the participant is assigned to.|
|Official Title:||Offsetting Hippocampal Degeneration in Moderate to Severe TBI|
|Actual Study Start Date :||July 25, 2019|
|Estimated Primary Completion Date :||July 2020|
|Estimated Study Completion Date :||July 2020|
For the treatment arm, the participants will complete the intervention protocol following the first in-person study visit 6 months post-injury. The intervention involves 16 weeks of online, in-home spatial navigation training. During the 16 weeks, the participant will complete exercises for 1 hour/day, every other day.
Behavioral: Online Spatial Navigation Training
Participants complete training tasks that test their spatial navigational abilities, cognitive map formation, and pattern separation. These training tasks involve map drawing, vector mapping, proximity judgments, and navigating with blocked routes.
No Intervention: Control
The control arm participants will receive their typical standard of care; they will not complete the intervention but will complete all of the in-person visits at the same post-injury time-points as the treatment group.
- Online Spatial Navigation Intervention Test Scores: Change in Spatial Learning Ability [ Time Frame: Time-point 1: 6 months post-injury and Time-point 2: 10 months post-injury ]Participants complete online spatial navigation training 5 days per week for 16 weeks. Improvement in spatial learning ability will be assessed based on the accuracy of answers to questions regarding the reproduction of spatial elements, the direction and proximity of certain landmarks, and describing the most efficient route from point A to point B. Improvement will be assessed at the end of each week and at the end of the intervention. The raw scores range from 0-15, with higher scores indicating better spatial learning ability.
- Online Spatial Navigation Intervention Test Scores: Change in Cognitive Map Formation [ Time Frame: Time-point 1: 6 months post-injury and Time-point 2: 10 months post-injury ]Participants complete online spatial navigation training 5 days per week for 16 weeks. Improvement in cognitive map formation will be assessed based on the number of trails required by the participant to learn landmark placements and based on the accuracy of the participant's navigation to a specific destination. The raw scores range from 1-21 and 0-10, respectively. A decrease in the number of trials required by the participant and an increase in navigation accuracy both correspond to an improvement in cognitive map formation.
- Online Spatial Navigation Intervention Test Scores: Change in Pattern Separation [ Time Frame: Time-point 1: 6 months post-injury and Time-point 2: 10 months post-injury ]Measurement of pattern separation abilities are assessed in a task requiring the participant to differentiate memories in order to prevent interference from overlapping details. The following three variables are taken into account: i) percent correct ii) the discriminating value and iii) bias metric. Percent correct and bias metric are given as a percentage values (e.g., 80.63%) and the discriminating variable is given as a raw rate (e.g., 0.67). An improvement in pattern separation abilities are determined by an increase in percent correct and discrimination values from pre- to post-intervention. An increase in bias metric from pre- to post-intervention reflects an increased tendency for pattern separation.
- Online Spatial Navigation Intervention Test Scores: Change in Pattern Completion [ Time Frame: Time-point 1: 6 months post-injury and Time-point 2: 10 months post-injury ]Measurement of pattern completion abilities are assessed in a task designed to probe pattern completion by presenting partial retrieval cues at different levels of degradation. The following variables are taken into account: i) accuracy for learned stimuli given as a percentage value (i.e., correctly selecting the name of the scene) ii) accuracy for new stimuli given as a percentage value (i.e., correctly indicating the stimuli is novel) and iii) bias measure. The bias measure is obtained by subtracting the learned stimuli accuracy score from the new stimuli accuracy score. An increase for both accuracy measures from pre- to post-intervention corresponds to improvement on recognition memory. An increase in bias measure reflects an increased tendency for pattern separation.
- Neuronal injury biomarker predictors in serum and plasma samples [ Time Frame: Time-point 1: 6 months post-injury and Time-point 2: 12 months post-injury ]The investigators will be analysing biomarkers in serum and plasma samples in relation to traumatic brain injuries. This will allow the investigators to generate hypotheses concerning the relationship between blood biomarkers and neuronal injury. Serum neurofilament light chains (NF-L), total tau, amyloid β-40 and amyloid β-42 will be assayed using Quanterix reagents on the Simoa HD-1 platform.
- Gliosis and inflammation biomarker predictors in serum samples [ Time Frame: Time-point 1: 6 months post-injury and Time-point 2: 12 months post-injury ]The investigators will be analysing biomarkers in serum samples in relation to gliosis and inflammation. This will allow the investigators to generate hypotheses concerning the relationship between blood biomarkers and neuroimmune response. Serum monocyte chemoattractant protein-1 (MCP-1) will be assayed using MesoScale Discovery reagents on the Sector S600 platform and glial fibrillary acidic protein (GFAP) will be assayed using Quanterix reagents on the Simoa HD-1 platform.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03727334
|Contact: Angela Aquino, BScfirstname.lastname@example.org|
|Contact: Victoria Purcellemail@example.com|
|Canada, British Columbia|
|Vancouver General Hopsital||Enrolling by invitation|
|Vancouver, British Columbia, Canada, V5Z 1M9|
|GF Strong Rehabilitation Centre||Recruiting|
|Vancouver, British Columbia, Canada, V5Z 2G9|
|Principal Investigator:||William Panenka, MD||University of British Columbia|
|Principal Investigator:||Robin Green, PhD||University Health Network, Toronto|