Traumatic Brain InjuryTBPMNCT04065477
Improving Time-Based Prospective Memory in TBI
A study testing computer-based cognitive rehabilitation (CBCR) in people with Traumatic Brain Injury, run by Kessler Foundation at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 59 years
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- computer-based cognitive rehabilitation (CBCR)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2019to 31 Dec 2026
- 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 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Sustained a moderate-to-severe TBI at least one year prior to assessment
- Fluent in English
- Demonstrate impairment in strategic cognitive abilities
Who cannot join
- Significant neurological history other than TBI
- Significant psychiatric history (e.g., bipolar disorder, schizophrenia)
- Significant substance abuse history
- Steroid and/or benzodiazepine use
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Improving Time-Based Prospective Memory in TBI: A Feasibility and Dosing Study
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).
Read the detailed description
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
- Traumatic Brain Injury
- Being tested
- computer-based cognitive rehabilitation (CBCR)
- Keywords
- Traumatic Brain Injury, TBI, Brain Injury
- 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.
computer-based cognitive rehabilitation (CBCR)Behavioural
Program designed to improve strategic cognitive domains (e.g., complex attention, working memory)
| Study group | Role | What they receive |
|---|---|---|
| Experimental | 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. Receives: Behavioral: computer-based cognitive rehabilitation (CBCR) |
| Control group | No intervention | The control group will receive no active treatment and will be treated as a "no-contact control" group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intervention Tolerability Assessment Scale
visual analog scale to assess participants' tolerability of intervention
Measured: baseline through final follow-up assessment (16 weeks)
Recruitment rate percentage
percentage of interested participants who met eligibility criteria via phone screen are eligible at in person screen
Measured: phone screen to in-person screen (within 2 weeks)
Retention rate percentage
adherence rate to treatment sessions within 8 weeks (i.e., attendance at 16 sessions), 12 weeks (24 sessions), and 16 weeks (32 sessions)
Measured: baseline to mid-intervention assessment #2 (8 weeks), mid-intervention assessment #3 (12 weeks), and final follow-up (16 weeks)
Secondary outcomes (2)
Changes in time monitoring & time-based prospective memory
Via a task that simultaneously assesses time monitoring frequency as it relates to time-based prospective memory performance.
Measured: 16 weeks
Changes in strategic cognitive functions (performance on NIH EXAMINER)
Via the NIH EXAMINER, a comprehensive computerized battery of tests designed to assess strategic cognitive functioning, particularly related to executive functions and related domains.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2019
- Study start1 Oct 2019
- Primary completion31 Mar 2023
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by Kessler FoundationThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kessler Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erica Weber, Kessler Foundation
- Investigators
- Erica Weber, PhD, Principal investigator, Kessler Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04065477
- Sponsor's protocol ID
- E-1071-19
- Acronym
- TBPM
- Status last verified
- Aug 2026
- First submitted
- 18 Jul 2019
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Time-Based Prospective Memory in TBI: A Feasibility and Dosing Study
- ClinicalTrials.gov ID
- NCT04065477
- Acronym / sponsor ID
- TBPM / E-1071-19
- Conditions
- Traumatic Brain Injury
- Keywords
- Traumatic Brain Injury, TBI, Brain Injury
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Kessler FoundationUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 22 Aug 2019 (actual)
- 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.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Behavioral: computer-based cognitive rehabilitation (CBCR)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. |
| Control group | No intervention | –The control group will receive no active treatment and will be treated as a "no-contact control" group. |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Sustained a moderate-to-severe TBI at least one year prior to assessment
- Fluent in English
- Demonstrate impairment in strategic cognitive abilities
Key exclusion criteria (4 listed)
- Significant neurological history other than TBI
- Significant psychiatric history (e.g., bipolar disorder, schizophrenia)
- Significant substance abuse history
- Steroid and/or benzodiazepine use
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 |
|---|---|---|
| computer-based cognitive rehabilitation (CBCR)Program designed to improve strategic cognitive domains (e.g., complex attention, working memory) | Behavioural | Experimental |
Primary outcome
Intervention Tolerability Assessment Scale
Time frame: baseline through final follow-up assessment (16 weeks)
visual analog scale to assess participants' tolerability of intervention
Recruitment rate percentage
Time frame: phone screen to in-person screen (within 2 weeks)
percentage of interested participants who met eligibility criteria via phone screen are eligible at in person screen
Retention rate percentage
Time frame: baseline to mid-intervention assessment #2 (8 weeks), mid-intervention assessment #3 (12 weeks), and final follow-up (16 weeks)
adherence rate to treatment sessions within 8 weeks (i.e., attendance at 16 sessions), 12 weeks (24 sessions), and 16 weeks (32 sessions)
2 secondary outcomes
Changes in time monitoring & time-based prospective memory
Time frame: 16 weeks
Changes in strategic cognitive functions (performance on NIH EXAMINER)
Time frame: 16 weeks
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 11 Aug 2026.
- Individual participant dataSharing planned: No
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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.
Erica Weber, PhD principal investigator
Kessler Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing computer-based cognitive rehabilitation (CBCR) in people with Traumatic Brain Injury, run by Kessler Foundation 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 3 inclusion and 4 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 11 Aug 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?
Intervention Tolerability Assessment Scale (time frame: baseline through final follow-up assessment (16 weeks)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Aug 2026.