Traumatic Brain Injury (TBI)NCT02918994
LearningRx Cognitive Training for Brain Injury
A study testing LearningRx cognitive training in people with Traumatic Brain Injury (TBI) and Acquired Brain Injury, run by Gibson Institute of Cognitive Research at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Traumatic Brain Injury (TBI), Acquired Brain Injury, Post COVID-19 Cognitive Impairment
- What is being tested?
- LearningRx cognitive training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2016to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18+ previously diagnosed with TBI/ABI
Who cannot join
- No braces, metal implants, or claustrophobia that would contraindicate magnetic resonance imaging for participants receiving MRI only
Trial locations and contacts
1 site in 1 country.
United States1 site
Gibson Institute of Cognitive Research
Colorado Springs, Colorado, 80919
About this study
Official title: LearningRx Cognitive Training for Traumatic Brain Injury (TBI) and Acquired Brain Injury (ABI)
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).
Read the detailed description
The proposed study will examine the outcomes from LearningRx one-on-one cognitive training across domains on standardized measures and qualitative measures used to monitor treatment effectiveness for brain injury.
- Being tested
- LearningRx cognitive training
- Medical subject headings
- Brain Injuries, Traumatic, Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LearningRx cognitive trainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| LearningRx cognitive training | Experimental | The intervention is a 60-90 hour, clinician-delivered cognitive training program. Receives: Behavioral: LearningRx cognitive training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evidence of Change in Workplace Self-Efficacy
Confirmed by change on 29-item Workplace Self-Efficacy Survey
Measured: Baseline and 9 months
Secondary outcomes (5)
Evidence of overall cognitive function improvement
Confirmed by change in pretest to post-test scores on the Woodcock Johnson IV - Tests of Cognitive Abilities
Measured: Baseline and 9 months
Evidence of Change in Self-Reported Functioning at Home and Work
Confirmed by qualitative interview of pre-intervention symptoms and functioning and post-intervention symptoms and functioning
Measured: Baseline and 9 months
Evidence of reduction in TBI symptoms
As confirmed by pretest to post-test changes on the Traumatic Brain Injury Checklist (Note: for TBI participants only)
Measured: Baseline and 9 months
Evidence of change in brain activity
As confirmed by pretest to post-test changes in electrical activity measured by qEEG. (Note: for TBI in-person participants only; not for remote participants)
Measured: Baseline and 9 months
Evidence of change in brain structure
Confirmed by change in pretest to post-test neuroimaging using MRI. (Note: for in-person TBI participants only; not for remote participants.)
Measured: Baseline and 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2016 (estimated)
- Study startSep 2016
- Primary completionSep 2025
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Traumatic Brain Injury (TBI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gibson Institute of Cognitive Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Louisiana State University Health Sciences Center Shreveport
- Responsible party
- Sponsor
- Investigators
- Christina Ledbetter, PhD, Principal investigator, Gibson Institute of Cognitive Research and LSU Health ShreveportAmy L Moore, PhD, Study director, Gibson Institute of Cognitive Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02918994
- Sponsor's protocol ID
- GICR-0916-B
- Status last verified
- Feb 2026
- First submitted
- 27 Sep 2016
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Will add to Harvard Dataverse
Publications
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.
PubMed 32670040
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LearningRx Cognitive Training for Traumatic Brain Injury (TBI) and Acquired Brain Injury (ABI)
- ClinicalTrials.gov ID
- NCT02918994
- Acronym / sponsor ID
- GICR-0916-B
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Gibson Institute of Cognitive ResearchIndustry (pharma, biotech, devices)
- Collaborators
- Louisiana State University Health Sciences Center Shreveport
- Study start
- Sep 2016
- Primary completion
- Sep 2025 (actual)
- Study completion
- Dec 2027 (estimated)
- First posted
- 29 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
The proposed study will examine the outcomes from LearningRx one-on-one cognitive training across domains on standardized measures and qualitative measures used to monitor treatment effectiveness for brain injury.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LearningRx cognitive training | Experimental | Behavioral: LearningRx cognitive trainingThe intervention is a 60-90 hour, clinician-delivered cognitive training program. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Age 18+ previously diagnosed with TBI/ABI
Key exclusion criteria (1 listed)
- No braces, metal implants, or claustrophobia that would contraindicate magnetic resonance imaging for participants receiving MRI only
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LearningRx cognitive trainingA 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. | Behavioural | LearningRx cognitive training |
Primary outcome
Evidence of Change in Workplace Self-Efficacy
Time frame: Baseline and 9 months
Confirmed by change on 29-item Workplace Self-Efficacy Survey
5 secondary outcomes
Evidence of overall cognitive function improvement
Time frame: Baseline and 9 months
Evidence of Change in Self-Reported Functioning at Home and Work
Time frame: Baseline and 9 months
Evidence of reduction in TBI symptoms
Time frame: Baseline and 9 months
Evidence of change in brain activity
Time frame: Baseline and 9 months
Evidence of change in brain structure
Time frame: Baseline and 9 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
- Derived from this study: PubMed 32670040Moore 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.
- Individual participant dataSharing planned: Yes. Will add to Harvard Dataverse
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christina Ledbetter, PhD principal investigator
Gibson Institute of Cognitive Research and LSU Health Shreveport
Amy L Moore, PhD study director
Gibson Institute of Cognitive Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LearningRx cognitive training in people with Traumatic Brain Injury (TBI) and Acquired Brain Injury, run by Gibson Institute of Cognitive Research at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evidence of Change in Workplace Self-Efficacy (time frame: Baseline and 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02918994, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2026.