Offsetting Hippocampal Degeneration in m-sTBI

NCT03727334 | Unknown

• 1 other identifier: H17-03544
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 2

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.

Conditions

Traumatic Brain Injury; Degeneration; Memory; Loss, Mild, Following Organic Brain Damage

Outcome Measures

Primary Outcomes (4)

• Online Spatial Navigation Intervention Test Scores: Change in Spatial Learning Ability

  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.

  Time-point 1: 7 months post-injury and Time-point 2: 12 months post-injury

• Online Spatial Navigation Intervention Test Scores: Change in Cognitive Map Formation

  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.

  Time-point 1: 7 months post-injury and Time-point 2: 12 months post-injury

• Online Spatial Navigation Intervention Test Scores: Change in Pattern Separation

  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.

  Time-point 1: 7 months post-injury and Time-point 2: 12 months post-injury

• Online Spatial Navigation Intervention Test Scores: Change in Pattern Completion

  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.

  Time-point 1: 7 months post-injury and Time-point 2: 12 months post-injury

Secondary Outcomes (2)

• Neuronal injury biomarker predictors in serum and plasma samples

  Time-point 1: 7 months post-injury and Time-point 2: 12 months post-injury

• Gliosis and inflammation biomarker predictors in serum samples

  Time-point 1: 7 months post-injury and Time-point 2: 12 months post-injury

Study Arms (2)

Treatment

EXPERIMENTAL

For the treatment arm, the participants will complete the intervention protocol following the first in-person study visit 7 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, 5 days a week.

Behavioral: Online Spatial Navigation Training

Control

NO INTERVENTION

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.

Interventions

Online Spatial Navigation Training BEHAVIORAL

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.

Treatment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of British Columbia: lead
• University Health Network, Toronto: collaborator

Study Sites (2)

Vancouver General Hopsital

Vancouver, British Columbia, V5Z 1M9, Canada

ENROLLING BY INVITATION

GF Strong Rehabilitation Centre

Vancouver, British Columbia, V5Z 2G9, Canada

RECRUITING

MeSH Terms

Conditions

Brain Injuries, Traumatic; Lymphoma, Follicular

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• William Panenka, MD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

• Robin Green, PhD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nishtha Parag, BSc

CONTACT

604-418-4160; nishthap@psych.ubc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The psychometrist will be blind to the arm the participant is assigned to.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: October 3, 2018
• First Posted: November 1, 2018
• Study Start: July 25, 2019
• Primary Completion: July 1, 2023
• Study Completion: July 1, 2024
• Last Updated: May 9, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)