NCT02918994

Brief Summary

The purpose of this investigation is to conduct a series of case studies on the impact of LearningRx cognitive training on cognitive skills, daily functioning, and workplace self-efficacy for participants with Traumatic Brain Injury (TBI) /Acquired Brain Injury (ABI).

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
19mo left

Started Sep 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress86%
Sep 2016Dec 2027

Study Start

First participant enrolled

September 1, 2016

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

September 27, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 29, 2016

Completed
8.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Expected
Last Updated

February 13, 2026

Status Verified

February 1, 2026

Enrollment Period

9 years

First QC Date

September 27, 2016

Last Update Submit

February 11, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Evidence of Change in Workplace Self-Efficacy

    Confirmed by change on 29-item Workplace Self-Efficacy Survey

    Baseline and 9 months

Secondary Outcomes (5)

  • Evidence of overall cognitive function improvement

    Baseline and 9 months

  • Evidence of Change in Self-Reported Functioning at Home and Work

    Baseline and 9 months

  • Evidence of reduction in TBI symptoms

    Baseline and 9 months

  • Evidence of change in brain activity

    Baseline and 9 months

  • Evidence of change in brain structure

    Baseline and 9 months

Study Arms (1)

LearningRx cognitive training

EXPERIMENTAL

The intervention is a 60-90 hour, clinician-delivered cognitive training program.

Behavioral: LearningRx cognitive training

Interventions

A clinician will deliver three 90-minute cognitive training sessions per week for 14 weeks. There are 16 different categories of leveled training procedures sequenced in intensity and difficulty for a total of 530 training tasks. Participants will receive training in-person or remotely depending on state of residence.

LearningRx cognitive training

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • \- Age 18+ previously diagnosed with TBI/ABI

You may not qualify if:

  • No braces, metal implants, or claustrophobia that would contraindicate magnetic resonance imaging for participants receiving MRI only

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gibson Institute of Cognitive Research

Colorado Springs, Colorado, 80919, United States

Location

Related Publications (1)

  • Moore AL, Carpenter DM 2nd, James RL, Miller TM, Moore JJ, Disbrow EA, Ledbetter CR. Neuroimaging and Neuropsychological Outcomes Following Clinician-Delivered Cognitive Training for Six Patients With Mild Brain Injury: A Multiple Case Study. Front Hum Neurosci. 2020 Jun 24;14:229. doi: 10.3389/fnhum.2020.00229. eCollection 2020.

MeSH Terms

Conditions

Brain Injuries, TraumaticBrain Injuries

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Christina Ledbetter, PhD

    Gibson Institute of Cognitive Research and LSU Health Shreveport

    PRINCIPAL INVESTIGATOR
  • Amy L Moore, PhD

    Gibson Institute of Cognitive Research

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 27, 2016

First Posted

September 29, 2016

Study Start

September 1, 2016

Primary Completion

September 1, 2025

Study Completion (Estimated)

December 1, 2027

Last Updated

February 13, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

Will add to Harvard Dataverse

Locations