- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06510023
Rewards Sensitivity After Brain Injury
Preserved Reward Sensitivity During Acute Rehabilitation Following Acquired Brain Injury
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Illinois
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Chicago, Illinois, United States, 60611
- Shirley Ryan AbilityLab
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
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
- 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.
Exclusion Criteria:
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Individuals with Acquired Brain Injury
Measuring the effect of three different types of rewards (one dollar, one penny, and no reward) on performance in a cognitive test.
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Three different types of rewards were presented to both groups during the computerized task: one dollar, one penny, and no reward.
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Other: Non-impaired controls
Measuring the effect of three different types of rewards (one dollar, one penny, and no reward) on performance in a cognitive test.
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Three different types of rewards were presented to both groups during the computerized task: one dollar, one penny, and no reward.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Performance on a Cued Response Reaction Time Task, in each of the three rewards conditions (Dollar, Penny, No reward)
Time Frame: 15 minutes
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Accuracy (percentage of correct responses) in a Cued Response Reaction task
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15 minutes
|
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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
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15 minutes
|
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Electrodermal activity (EDA) before, during and after the Cued Response Reaction task
Time Frame: 30 minutes
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Number of skin conductance responses (SCRs) before, during and after the task
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30 minutes
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Shira Cohen-Zimerman, PhD, Shirley Ryan AbilityLab
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STU00213877
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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