- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04799340
Computer-based Training of Face Recollection to Improve Face Recognition in Developmental Prosopagnosia
November 23, 2022 updated by: Joseph DeGutis, Boston VA Research Institute, Inc.
Characterizing and Remediating Recollection-specific Face Recognition Deficits in Developmental Prosopagnosia
This study will examine the effectiveness of a cognitive training intervention targeting face recollection, repetition lag training, at improving face recognition in Developmental Prosopagnosia.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Joseph M DeGutis, Ph.D.
- Phone Number: 510-734-7705
- Email: degutis@hms.harvard.edu
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02130
- Recruiting
- VA Boston Healthcare System, 150 S. Huntington Ave.
-
Contact:
- Joseph M DeGutis, Ph.D.
- Phone Number: 510-734-7705
- Email: degutis@hms.harvard.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
Developmental prosopagnosic participants will be included if they are...
- aged 18-90,
- have lifelong histories of face recognition difficulties that impact their everyday life (i.e., not associated with some event such as a stroke, seizure, etc)
- score significantly below the mean on the famous faces test and Cambridge Face Memory Test
Exclusion Criteria:
Participants will be excluded from the study if they...
- have a history of a significant neurological disorder including hydrocephalus, stroke, moderate to severe traumatic brain injury (TBI), severe neuromuscular diseases, or severe hypoxia due to cardiac arrest.
- have impairments that interfere with cognitive performance, such as uncorrected hearing or vision, lack of English proficiency, musculoskeletal or other issues
- have psychiatric disorders, such as schizophrenia, major depressive disorder, bipolar disorder, chronic intractable obsessive-compulsive disorder, or agoraphobia.
- We will exclude individuals who are currently dependent on alcohol or other substances, as this may negatively impact cognitive performance.
- We will exclude participants who currently are, or within the last 6 months, participating in a behavioral or pharmacological intervention.
- Patients with a history of mild TBI or simple concussion will not be excluded as long as it was > 6 months ago and as long as they have not had repeated concussions (>5)
- We will include individuals with a diagnosis of ADHD as long as their medication has been consistent for the past 6 months.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: waitlist control
|
|
|
Experimental: holistic face training + repetition lag training
|
training to improve encoding and recognition of faces
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cambridge Face Memory Test
Time Frame: 15 minutes
|
learning and recognizing novel faces, out of 72 (higher score is better)
|
15 minutes
|
|
Face Recollection
Time Frame: 15 minutes
|
old/new face recognition test, extracting familiarity and recollection parameters, higher score is better
|
15 minutes
|
|
Face Perception
Time Frame: 30 minutes
|
composite of face matching tasks, Cambridge Face perception Test and computerized Benton, higher score is better
|
30 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Self-reported face recognition
Time Frame: 5 minutes
|
questionnaire
|
5 minutes
|
|
Face-name learning task
Time Frame: 15 minutes
|
15 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 12, 2021
Primary Completion (Anticipated)
May 31, 2025
Study Completion (Anticipated)
July 1, 2025
Study Registration Dates
First Submitted
March 11, 2021
First Submitted That Met QC Criteria
March 11, 2021
First Posted (Actual)
March 16, 2021
Study Record Updates
Last Update Posted (Actual)
November 29, 2022
Last Update Submitted That Met QC Criteria
November 23, 2022
Last Verified
November 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R21EY031000, R01EY032510
- R21EY031000 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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