Offsetting Hippocampal Degeneration in m-sTBI

University of British Columbia

Status: Enrolling

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

Treatments: Behavioral: Online Spatial Navigation Training

Study type: Interventional

Funder types: Other

Identifiers

NCT03727334

H17-03544

Details and patient eligibility

About

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.

Full 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.

Enrollment: 25 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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25 participants in 2 patient groups

Treatment

Experimental group

Description:

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.

Treatment:

Behavioral: Online Spatial Navigation Training

Control

No Intervention group

Description:

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.