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NCT04560946 · ClinicalTrials.gov registry record · NA

Personalized, Augmented Cognitive Training (PACT) for Service Members and Veterans with a History of TBI

A NA study of Traumatic Brain Injury, sponsored by Veterans Medical Research Foundation.

Completed
Registry status
NA
Development phase
107
Enrollment target
2
Study locations

NCT04560946 is a NA study of Traumatic Brain Injury that has completed, run by Veterans Medical Research Foundation. The registered enrollment target is 107 participants, below the 277-participant average among 171 other Traumatic Brain Injury trials with a reported enrollment target (61% lower). The trial reports 2 study locations across 1 state.

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The verdict

NCT04560946, a NA study of Traumatic Brain Injury, has completed, sponsored by Veterans Medical Research Foundation.

COMPLETED
Registry status
NA
Development phase
107 participants
Enrollment target
2
Study locations

Study Summary

Mild traumatic brain injury (TBI) is a common medical condition that occurs when a head injury causes someone to lose consciousness, feel dazed or confused, or be unable to remember events occurring immediately after the injury. While most individuals with mild TBI recover within weeks or months, some individuals with mild TBI report chronic symptoms such as difficulty with cognitive skills like attention, learning, or memory, along with other symptoms such as irritability or headache. Previous studies, including those conducted by our scientific team, have shown that cognitive rehabilitation can help patients with persistent symptoms after mild TBI return to full duty, work, school, and other important life activities. Specifically, cognitive rehabilitation can provide lasting improvements in thinking abilities, functional capacity, post-concussive symptoms, and quality of life after mild TBI. However, effective interventions are still out of reach for many service members and Veterans with TBI. For patients who have returned to duty, employment, or education, scheduling up to 60 hours of treatment (a typical treatment schedule in many settings) may not be feasible. Additionally, some patients may live in areas where it is burdensome to make numerous visits to a medical center. Personalized Augmented Cognitive Training (PACT) compresses treatment into six hours of once-weekly personalized, one-on-one training by selecting treatment modules based on patient needs and priorities-substantially reducing the total amount of time required to complete treatment. PACT can be offered either in-person (in clinic) or via home-based video telemedicine, depending upon patients' preferences. Additionally, PACT includes training and encouragement for service members and Veterans to make self-directed use of mobile apps that train cognitive skills and strategies.The primary goal of this study is to evaluate whether PACT is effective at improving cognition, symptoms, and functional

Conditions Studied

Interventions

  • BEHAVIORAL Personalized Augmented Cognitive Training (PACT)
  • BEHAVIORAL Enhanced Treatment As Usual

Study Locations (2)

California

  • Naval Medical Center San Diego - San Diego
  • VA San Diego Healthcare System - San Diego

Trial Details

FieldValue
Enrollment Target 107 participants
Start Date 2019-09-30
Est. Completion 2023-09-30
Phase NA

What the Registry Record Tells You About NCT04560946

The ClinicalTrials.gov registry entry for NCT04560946 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 107 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 277-participant average among 171 other Traumatic Brain Injury trials with a reported enrollment target (61% lower). The listed sponsor is Veterans Medical Research Foundation, which has 35 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Traumatic Brain Injury appearing as the primary indexed condition, and to 2 interventions - of which Personalized Augmented Cognitive Training (PACT) is the first listed.

NCT04560946 reports 2 study locations spanning 1 distinct geographic area - top geographies include California.

Frequently Asked Questions

What is clinical trial NCT04560946 about?

NCT04560946 is a clinical study titled "Personalized, Augmented Cognitive Training (PACT) for Service Members and Veterans with a History of TBI". Mild traumatic brain injury (TBI) is a common medical condition that occurs when a head injury causes someone to lose consciousness, feel dazed or confused, or be unable to remember events occurring immediately after the injury. While most individuals with mild TBI recover within weeks or months, so...

What is the current status of trial NCT04560946?

This trial is currently completed. It is a NA study. The enrollment target is 107 participants. The study started on 2019-09-30. Estimated completion is 2023-09-30.

What conditions does trial NCT04560946 study?

This clinical trial studies the following conditions: Traumatic Brain Injury.

What interventions are being tested in trial NCT04560946?

The interventions under investigation include: Personalized Augmented Cognitive Training (PACT) (BEHAVIORAL), Enhanced Treatment As Usual (BEHAVIORAL).

Who is sponsoring clinical trial NCT04560946?

This trial is sponsored by Veterans Medical Research Foundation, which has 35 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04560946 being conducted?

This trial has 2 study locations across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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