Improving Time-Based Prospective Memory in TBI

NCT ID: NCT04065477

Last Updated: 2024-01-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-01

Study Completion Date

2024-03-31

Brief Summary

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This research aims to test aspects of a computer-based cognitive rehabilitation program designed to improve thinking skills in individuals with traumatic brain injury (TBI).

Detailed Description

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This research aims to test aspects of a computer-based cognitive rehabilitation program designed to improve thinking skills in individuals with traumatic brain injury (TBI), particularly improving the ability to remember to do things in the future.

Conditions

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Traumatic Brain Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Investigators
Study staff conducting baseline and follow-up assessments will be blind as to which group participants are placed. Study staff conducting intervention sessions will be blind to participants' baseline and follow-up assessment performance.

Study Groups

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Experimental

The experimental group will receive treatment program designed to train strategic cognitive functions. Sessions will last 50 minutes and take place twice per week for 16 weeks.

Group Type EXPERIMENTAL

computer-based cognitive rehabilitation (CBCR)

Intervention Type BEHAVIORAL

Program designed to improve strategic cognitive domains (e.g., complex attention, working memory)

Control group

The control group will receive no active treatment and will be treated as a "no-contact control" group.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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computer-based cognitive rehabilitation (CBCR)

Program designed to improve strategic cognitive domains (e.g., complex attention, working memory)

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Sustained a moderate-to-severe TBI at least one year prior to assessment
* Fluent in English
* Demonstrate impairment in strategic cognitive abilities

Exclusion Criteria

* Significant neurological history other than TBI
* Significant psychiatric history (e.g., bipolar disorder, schizophrenia)
* Significant substance abuse history
* Steroid and/or benzodiazepine use
Minimum Eligible Age

18 Years

Maximum Eligible Age

59 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kessler Foundation

OTHER

Sponsor Role lead

Responsible Party

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Erica Weber

Research Scientist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Erica Weber, PhD

Role: PRINCIPAL_INVESTIGATOR

Kessler Foundation

Locations

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Kessler Foundation

East Hanover, New Jersey, United States

Site Status

Countries

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United States

Other Identifiers

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E-1071-19

Identifier Type: -

Identifier Source: org_study_id

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