Brain InjuriesNCT03752697
Metacognition in Neurological Injury
An observational study of Brain Injuries, run by University of Nebraska Lincoln at 1 site in United States.
Trial summary
The purpose of this study is to investigate the trajectory of metacognitive functioning throughout phases of recovery from neurological insult, and to determine its relationship to rehabilitation compliance and functional outcome. Read more about this study
- Who is it for?
- Ages 19 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Brain Injuries
- What is being tested?
- metacognitive performance
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Dec 2018to 30 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 19 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: participants in rehabilitation facility and community-dwelling individuals
Who may be able to join
- history of brain and/or spinal cord injury
- no history of brain or neurological injury/insult (for healthy control group)
- fluent in spoken and written English
- adequate gross motor abilities to provide a button push on a keyboard
Who cannot join
- current/past history of psychiatric illness
- learning disorder
- developmental disorder
- diagnosis of Attention Deficit Disorder/Attention Deficit Hyperactive Disorder
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Nebraska-Lincoln
Lincoln, Nebraska, 68588-0308
About this study
Official title: Longitudinal Examination of Metacognition in Neurological Samples
The purpose of this study is to investigate the trajectory of metacognitive functioning throughout phases of recovery from neurological insult, and to determine its relationship to rehabilitation compliance and functional outcome. It is hypothesized that metacognitive accuracy improves over time, and is a significant predictor of engagement in rehabilitation activities.
Read the detailed description
This study will examine the trajectory of metacognitive functioning through different phases of recovery from neurological insult, and document its relationship to rehabilitation compliance. Individuals currently completing rehabilitation programs and individuals from the community who meet study criteria are invited to participate. After consenting and enrolling in the study, participants complete 2 study sessions: a baseline session, and a follow-up session either at time of completion of rehabilitation program or 3 months later if not in a rehabilitation program. During the study sessions, participants will complete paper-and-pencil and computerized tests of cognition (including metacognitive tasks).
- Conditions
- Brain Injuries
- Being tested
- metacognitive performance
- Keywords
- metacognition, self-assessment
- Medical subject headings
- Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
metacognitive performanceBehavioural
Paper and pencil/computerized tests of metacognition
| Study group | Role | What they receive |
|---|---|---|
| Neurological injury | Paper and pencil/computerized assessments of cognitive functioning and metacognitive performance will be administered. Receives: Behavioral: metacognitive performance | |
| Healthy control | Paper and pencil/computerized assessments of cognitive functioning and metacognitive performance will be administered. Receives: Behavioral: metacognitive performance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline metamemory performance to completion of rehabilitation
The computerized metamemory test produces scores that are used to calculate a gamma coefficient, which is a quantitative measure of the individual's metacognitive performance/accuracy.
Measured: At baseline and at end of length of stay in rehabilitative setting (on average 3 months)
Secondary outcomes (1)
Change in rehabilitative engagement
The rehabilitative engagement questionnaire is a clinician-report measure that queries the clinician's perception of their client's participation in rehabilitation services.
Measured: At baseline and at end of length of stay in rehabilitative setting (on average 3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2018
- Study start13 Dec 2018
- Primary completion30 Mar 2023
- Study completion30 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain InjuriesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska Lincoln
- Sponsor type
- University, hospital or other
- Collaborators
- Quality Living, Inc.
- Responsible party
- Sponsor
- Investigators
- Kathy Chiou, Ph.D., Principal investigator, University of Nebraska Lincoln
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03752697
- Sponsor's protocol ID
- 18123
- Status last verified
- Aug 2026
- First submitted
- 25 Sep 2018
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Examination of Metacognition in Neurological Samples
- ClinicalTrials.gov ID
- NCT03752697
- Acronym / sponsor ID
- 18123
- Conditions
- Brain Injuries
- Keywords
- metacognition, self-assessment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Nebraska LincolnUniversity, hospital or other
- Collaborators
- Quality Living, Inc.
- Study start
- 13 Dec 2018 (actual)
- Primary completion
- 30 Mar 2023 (actual)
- Study completion
- 30 Mar 2023 (actual)
- First posted
- 26 Nov 2018 (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.
The purpose of this study is to investigate the trajectory of metacognitive functioning throughout phases of recovery from neurological insult, and to determine its relationship to rehabilitation compliance and functional outcome. It is hypothesized that metacognitive accuracy improves over time, and is a significant predictor of engagement in rehabilitation activities.
Detailed description
This study will examine the trajectory of metacognitive functioning through different phases of recovery from neurological insult, and document its relationship to rehabilitation compliance. Individuals currently completing rehabilitation programs and individuals from the community who meet study criteria are invited to participate. After consenting and enrolling in the study, participants complete 2 study sessions: a baseline session, and a follow-up session either at time of completion of rehabilitation program or 3 months later if not in a rehabilitation program. During the study sessions, participants will complete paper-and-pencil and computerized tests of cognition (including metacognitive tasks).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neurological injury | – | Behavioral: metacognitive performancePaper and pencil/computerized assessments of cognitive functioning and metacognitive performance will be administered. |
| Healthy control | – | Behavioral: metacognitive performancePaper and pencil/computerized assessments of cognitive functioning and metacognitive performance will be administered. |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- participants in rehabilitation facility and community-dwelling individuals
Key inclusion criteria (4 listed)
- history of brain and/or spinal cord injury
- no history of brain or neurological injury/insult (for healthy control group)
- fluent in spoken and written English
- adequate gross motor abilities to provide a button push on a keyboard
Key exclusion criteria (4 listed)
- current/past history of psychiatric illness
- learning disorder
- developmental disorder
- diagnosis of Attention Deficit Disorder/Attention Deficit Hyperactive Disorder
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 |
|---|---|---|
| metacognitive performancePaper and pencil/computerized tests of metacognition | Behavioural | Healthy control, Neurological injury |
Primary outcome
Change from baseline metamemory performance to completion of rehabilitation
Time frame: At baseline and at end of length of stay in rehabilitative setting (on average 3 months)
The computerized metamemory test produces scores that are used to calculate a gamma coefficient, which is a quantitative measure of the individual's metacognitive performance/accuracy.
1 secondary outcome
Change in rehabilitative engagement
Time frame: At baseline and at end of length of stay in rehabilitative setting (on average 3 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Brain Injuries
Not yet recruitingObservational study
Changes in Land-Based Motor Function After Routine Hydrotherapy in Children With Cerebral Palsy
Cerebral Palsy
Enrolling by invitationObservational study
Assessment of Traumatic Brain Injury Using Transcranial Magnetic Stimulated Evoked Potentials
Traumatic Brain Injury
RecruitingObservational study
CoMind Early Feasibility Study
Intracranial Pressure, Intracranial Pressure Changes
Recruiting
MindEx: A Novel, Multifocal, Cognitive Brain-Machine Interface System
Paralysis; Quadriplegic, Quadraplegia
Enrolling by invitation
Improving In-hospital and Post-discharge Patient Education for Mild Traumatic Brain Injury
Concussion, Mild, Traumatic Brain Injury
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.
Kathy Chiou, Ph.D. principal investigator
University of Nebraska Lincoln
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Injuries, run by University of Nebraska Lincoln 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 4 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: finished, as of the sponsor's last update on 1 Sep 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change from baseline metamemory performance to completion of rehabilitation (time frame: At baseline and at end of length of stay in rehabilitative setting (on average 3 months)). 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 1 Sep 2026.