NCT06510023

Brief Summary

A study measuring rewards sensitivity in individuals with acquired brain injury at an acute rehabilitation level.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 21, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2022

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

July 11, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 19, 2024

Completed
Last Updated

July 19, 2024

Status Verified

July 1, 2024

Enrollment Period

12 months

First QC Date

July 11, 2024

Last Update Submit

July 18, 2024

Conditions

Keywords

Rewards SensitivityMotivationAcquired Brain InjuryElectrodermal Activity

Outcome Measures

Primary Outcomes (3)

  • 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

    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

    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

    30 minutes

Study Arms (2)

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.

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.

Behavioral: Type of reward presented

Interventions

Three different types of rewards were presented to both groups during the computerized task: one dollar, one penny, and no reward.

Individuals with Acquired Brain InjuryNon-impaired controls

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shirley Ryan AbilityLab

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Brain Injuries

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Shira Cohen-Zimerman, PhD

    Shirley Ryan AbilityLab

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
FACTORIAL
Model Details: 2X3 non-randomized, within-participant design.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Scientist

Study Record Dates

First Submitted

July 11, 2024

First Posted

July 19, 2024

Study Start

March 21, 2021

Primary Completion

March 20, 2022

Study Completion

March 20, 2022

Last Updated

July 19, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations