Clinical trial · Interventional
Offsetting Hippocampal Degeneration in m-sTBI
Offsetting Hippocampal Degeneration in Moderate to Severe TBI
NCT03727334CI-TRIAL-00066255m-sTBIunknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Degeneration | — | UNRESOLVED | — |
| Memory; Loss, Mild, Following Organic Brain Damage | — | UNRESOLVED | — |
| Traumatic Brain Injury | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Online Spatial Navigation Training | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Treatment
- 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.
- interventionNames
- Behavioral: Online Spatial Navigation Training
- type
- NO_INTERVENTION
- label
- Control
- 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.
Primary outcomes (4)
- measure
- Online Spatial Navigation Intervention Test Scores: Change in Spatial Learning Ability
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.