Acquired Brain InjuryNCT06510023
Rewards Sensitivity After Brain Injury
A study testing Type of reward presented in people with Acquired Brain Injury, run by Shirley Ryan AbilityLab at 1 site in United States.
Trial summary
A study measuring rewards sensitivity in individuals with acquired brain injury at an acute rehabilitation level. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Acquired Brain Injury
- What is being tested?
- Type of reward presented
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Mar 2021to 20 Mar 2022
- Phase
- Interventional
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Individuals with ABI
- Diagnosis of Traumatic Brain Injury or Stroke, based on their medical records
- Age between 18-100
- Able to follow directions in English (measured informally during screening)
- Able to use at least one upper extremity (demonstrated by holding a pen)
- Mild-moderate or lesser diagnosis in cognitive-communication area
Show all 13Show fewer
- Score of 25 or higher on the Orientation Log assessment
- Able to consent for participation in study (identifies through chart review)
- Capable of understanding and cooperating with the experimental procedures.
- Healthy participants
- Age of 18 to 100 years old
- Ability to follow directions in English
- Ability to use at least one upper extremity.
Who cannot join
- Individuals with ABI
- Additional diagnosis of a neurological disorder other than ABI
- Additional diagnosis of aphasia.
- Having cognitive or behavioral impairments that preclude participation in the experimental procedures
- Healthy Participants
- history of significant cerebrovascular or neurological disease including (but not limited to) meningitis, epilepsy and/or seizures, stroke, tumor, multiple sclerosis, meningitis, mental retardation, dementia.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Preserved Reward Sensitivity During Acute Rehabilitation Following Acquired Brain Injury
A study measuring rewards sensitivity in individuals with acquired brain injury at an acute rehabilitation level.
Read the detailed description
Individuals in acute rehabilitation following acquired brain injury journal (ABI) and aged-matched, non-injured controls will be recruited for this study.
Testing sessions will take place in a private treatment room at the Shirley Ryan AbilityLab and required 45 minutes to complete. Upon entering the room, participants will be greeted, electrodes placed on the participant's fingers to record their electrodermal activity, and participants will provide demographic information. Participants will then be instructed about how to respond on the Cued Reinforcement Response Time task (CRRT, see description below), and complete the task on a laptop computer while their electrodermal activity is being recorded. In this task, they are instructed to respond as quickly and accurately as possible, and will be informed that they will receive a monetary reward based on their accuracy at the completion of the task. Finally, participants will complete 3 self-report measures: (1) explicit level of motivation was measured in a post-study survey which included two items from the Sensitivity to Punishment and Sensitivity to Reward Questionnaire, (SPSRQ); (2) Reward sensitivity was evaluated using the Reward Responsiveness Scale , and (3) depression was evaluated using the Patient Health Questionnaire (PHQ-8) survey. At the end of the session, the electrodes will be removed, and participants will be debriefed and provided their monetary reward
- Conditions
- Acquired Brain Injury
- Being tested
- Type of reward presented
- Keywords
- Rewards Sensitivity, Motivation, Acquired Brain Injury, Electrodermal Activity
- Medical subject headings
- Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Type of reward presentedBehavioural
Three different types of rewards were presented to both groups during the computerized task: one dollar, one penny, and no reward.
| Study group | Role | What they receive |
|---|---|---|
| Individuals with Acquired Brain Injury | Experimental | Measuring the effect of three different types of rewards (one dollar, one penny, and no reward) on performance in a cognitive test. Receives: Behavioral: Type of reward presented |
| Non-impaired controls | Other | Measuring the effect of three different types of rewards (one dollar, one penny, and no reward) on performance in a cognitive test. Receives: Behavioral: Type of reward presented |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance on a Cued Response Reaction Time Task, in each of the three rewards conditions (Dollar, Penny, No reward)
Accuracy (percentage of correct responses) in a Cued Response Reaction task
Measured: 15 minutes
Performance on a Cued Response Reaction Time Task, in each of the three rewards conditions (Dollar, Penny, No reward)
Response time (time in milliseconds) in a Cued Response Reaction task
Measured: 15 minutes
Electrodermal activity (EDA) before, during and after the Cued Response Reaction task
Number of skin conductance responses (SCRs) before, during and after the task
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2024
- Study start21 Mar 2021
- Primary completion20 Mar 2022
- Study completion20 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acquired Brain InjuryStudies 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Model description
- 2X3 non-randomized, within-participant design.
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shirley Ryan AbilityLab
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shira Cohen-Zimerman, Shirley Ryan AbilityLab
- Investigators
- Shira Cohen-Zimerman, PhD, Principal investigator, Shirley Ryan AbilityLab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06510023
- Sponsor's protocol ID
- STU00213877
- Status last verified
- Jul 2024
- First submitted
- 11 Jul 2024
- Last updated
- 19 Jul 2024
- 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 19 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preserved Reward Sensitivity During Acute Rehabilitation Following Acquired Brain Injury
- ClinicalTrials.gov ID
- NCT06510023
- Acronym / sponsor ID
- STU00213877
- Conditions
- Acquired Brain Injury
- Keywords
- Rewards Sensitivity, Motivation, Acquired Brain Injury, Electrodermal Activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Shirley Ryan AbilityLabUniversity, hospital or other
- Study start
- 21 Mar 2021 (actual)
- Primary completion
- 20 Mar 2022 (actual)
- Study completion
- 20 Mar 2022 (actual)
- First posted
- 19 Jul 2024 (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.
A study measuring rewards sensitivity in individuals with acquired brain injury at an acute rehabilitation level.
Detailed description
Individuals in acute rehabilitation following acquired brain injury journal (ABI) and aged-matched, non-injured controls will be recruited for this study.
Testing sessions will take place in a private treatment room at the Shirley Ryan AbilityLab and required 45 minutes to complete. Upon entering the room, participants will be greeted, electrodes placed on the participant's fingers to record their electrodermal activity, and participants will provide demographic information. Participants will then be instructed about how to respond on the Cued Reinforcement Response Time task (CRRT, see description below), and complete the task on a laptop computer while their electrodermal activity is being recorded. In this task, they are instructed to respond as quickly and accurately as possible, and will be informed that they will receive a monetary reward based on their accuracy at the completion of the task. Finally, participants will complete 3 self-report measures: (1) explicit level of motivation was measured in a post-study survey which included two items from the Sensitivity to Punishment and Sensitivity to Reward Questionnaire, (SPSRQ); (2) Reward sensitivity was evaluated using the Reward Responsiveness Scale , and (3) depression was evaluated using the Patient Health Questionnaire (PHQ-8) survey. At the end of the session, the electrodes will be removed, and participants will be debriefed and provided their monetary reward
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 2X3 non-randomized, within-participant design.
| Arm | Type | Receives |
|---|---|---|
| Individuals with Acquired Brain Injury | Experimental | Behavioral: Type of reward presentedMeasuring the effect of three different types of rewards (one dollar, one penny, and no reward) on performance in a cognitive test. |
| Non-impaired controls | Other | Behavioral: Type of reward presentedMeasuring the effect of three different types of rewards (one dollar, one penny, and no reward) on performance in a cognitive test. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Individuals with ABI
- Healthy participants
- Age of 18 to 100 years old
- Ability to follow directions in English
- Ability to use at least one upper extremity.
Key exclusion criteria (6 listed)
- Individuals with ABI
- Healthy Participants
- history of significant cerebrovascular or neurological disease including (but not limited to) meningitis, epilepsy and/or seizures, stroke, tumor, multiple sclerosis, meningitis, mental retardation, dementia.
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 |
|---|---|---|
| Type of reward presentedThree different types of rewards were presented to both groups during the computerized task: one dollar, one penny, and no reward. | Behavioural | Individuals with Acquired Brain Injury, Non-impaired controls |
Primary outcome
Performance on a Cued Response Reaction Time Task, in each of the three rewards conditions (Dollar, Penny, No reward)
Time frame: 15 minutes
Accuracy (percentage of correct responses) in a Cued Response Reaction task
Performance on a Cued Response Reaction Time Task, in each of the three rewards conditions (Dollar, Penny, No reward)
Time frame: 15 minutes
Response time (time in milliseconds) in a Cued Response Reaction task
Electrodermal activity (EDA) before, during and after the Cued Response Reaction task
Time frame: 30 minutes
Number of skin conductance responses (SCRs) before, during and after the task
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 19 Jul 2024.
- 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.
Shira Cohen-Zimerman, PhD principal investigator
Shirley Ryan AbilityLab
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Type of reward presented in people with Acquired Brain Injury, run by Shirley Ryan AbilityLab 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 13 inclusion and 6 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 19 Jul 2024. 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?
Performance on a Cued Response Reaction Time Task, in each of the three rewards conditions (Dollar, Penny, No reward) (time frame: 15 minutes). 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 19 Jul 2024.