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Behavioral Intervention

Online Spatial Navigation Training for Traumatic Brain Injury (m-sTBI Trial)

N/A
Recruiting
Led By William Panenka, MD
Research Sponsored by University of British Columbia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have functional use of one upper extremity
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up time-point 1: 7 months post-injury and time-point 2: 12 months post-injury
Awards & highlights

m-sTBI Trial Summary

This trial will help researchers understand if it's possible to improve memory in patients with m-sTBI, and what effect the intervention has on the brain.

Who is the study for?
This trial is for adults aged 18-65 who've had a moderate or severe traumatic brain injury (m-sTBI), confirmed by CT or MRI scans. Participants must speak English, be able to give informed consent, have basic computer skills and internet access, and can use one upper extremity. Those with MRI contraindications, other neurological disorders, systemic conditions like diabetes or language impairments from the injury cannot join.Check my eligibility
What is being tested?
The study tests an online spatial navigation training program aimed at improving memory in patients with m-sTBI. It will also assess how this intervention affects brain structures related to memory and cognitive function.See study design
What are the potential side effects?
Since the intervention involves non-invasive online training exercises, no direct physical side effects are expected from participating in this clinical trial.

m-sTBI Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can use one of my arms or hands.
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I have been diagnosed with a severe brain injury.
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I am between 18 and 65 years old.

m-sTBI Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~time-point 1: 7 months post-injury and time-point 2: 12 months post-injury
This trial's timeline: 3 weeks for screening, Varies for treatment, and time-point 1: 7 months post-injury and time-point 2: 12 months post-injury for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Online Spatial Navigation Intervention Test Scores: Change in Cognitive Map Formation
Online Spatial Navigation Intervention Test Scores: Change in Pattern Completion
Online Spatial Navigation Intervention Test Scores: Change in Pattern Separation
+1 more
Secondary outcome measures
Gliosis and inflammation biomarker predictors in serum samples
Tumor Markers

m-sTBI Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: TreatmentExperimental Treatment1 Intervention
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.
Group II: ControlActive Control1 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.

Find a Location

Who is running the clinical trial?

University Health Network, TorontoOTHER
1,463 Previous Clinical Trials
483,509 Total Patients Enrolled
University of British ColumbiaLead Sponsor
1,410 Previous Clinical Trials
1,766,584 Total Patients Enrolled
William Panenka, MDPrincipal InvestigatorUniversity of British Columbia

Media Library

Online Spatial Navigation Training (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT03727334 — N/A
Traumatic Brain Injury Research Study Groups: Control, Treatment
Traumatic Brain Injury Clinical Trial 2023: Online Spatial Navigation Training Highlights & Side Effects. Trial Name: NCT03727334 — N/A
Online Spatial Navigation Training (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03727334 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

May I join the clinical evaluation in progress?

"This clinical trial is seeking 25 individuals, aged between 18 and 65 who have experienced some form of degeneration. In addition to the age requirements, participants must also meet certain criteria such as experiencing post-traumatic amnesia for at least 24 hours; a lowest Glasgow Coma Scale score less than 13; present with a positive Clinical CT or MRI scan; possess basic computer competency; demonstrate functional use of one upper extremity; access to the internet; be fluent in English and able to provide fully informed consent 6 months after their initial injury."

Answered by AI

Are there any available spots left to join this medical experiment?

"Affirmative, clinicaltrials.gov hosts data which confirms that this research is currently recruiting volunteers. It was first posted on July 25th 2019 and last modified February 11th 2022; the trial needs to enlist a total of 25 participants from two sites."

Answered by AI

Is the eligibility age for this experiment greater than twenty-five?

"Prospective participants must be of legal age and no more than 65 years in age to join this trial."

Answered by AI

How many participants are being assessed in this experiment?

"Affirmative, as clinicaltrials.gov evidences this study is currently recruiting patients. It was first posted on July 25th 2019 with the last update taking place on February 11th 2022 and requires 25 participants to be enrolled from 2 trial sites."

Answered by AI
~4 spots leftby Mar 2025