Recruiting

Hippocampal Degeneration

Sponsor:

University of British Columbia

Code:

NCT03727334

Conditions

Traumatic Brain Injury

Degeneration

Memory; Loss, Mild, Following Organic Brain Damage

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Online Spatial Navigation Training

Study Details

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

Study ID

NCT03727334

Start date

Jul 25, 2019

Status verified date

May, 2023

Completion date

Jul, 2024

Anticipated

Primary completion date

Jul, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

25 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment

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.

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.

Interventions

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.

Primary outcome measure

  • Online Spatial Navigation Intervention Test Scores: Change in Spatial Learning Ability [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Time-point 1: 7 months post-injury and Time-point 2: 12 months post-injury ]

Central Contacts and Locations

Central contacts

Nishtha Parag, BSc

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

Locations

GF Strong Rehabilitation Centre

Recruiting

Vancouver, British Columbia, Canada, V5Z 2G9

More Information

Sponsor

University of British Columbia

Last update posted

May 9, 2023

Last verified

May, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of British Columbia on 2023-05-09.