- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05800782
Face Perception vs. Memory Training to Improve Face Recognition in Developmental Prosopagnosia
January 10, 2024 updated by: Boston VA Research Institute, Inc.
Examining the Effectiveness of Face Perception and Memory Training to Improve Face Recognition in Developmental Prosopagnosia
The goal of this study is to test the effectiveness of two experimental training programs aimed at improving face processing in developmental prosopagnosia (perception training, memory training) in comparison to an active control.
The investigators will use a longitudinal design and randomize developmental prosopagnosics to three parallel arms: active control, perception training and memory training.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
The investigators propose a longitudinal design with three parallel arms: active control, perception training and memory training.
To maximize power, developmental prosopagnosics (DPs) in the active control group will be subsequently be offered training.
Pre-training/control assessments will be performed and within 2 weeks, DPs will be randomized to one of the three training conditions.
Next, all DPs will complete 6-weeks of their assigned intervention.
The research assistant will provide coaching at least once per week.
DPs will be assessed within two weeks of training completion and after a 12-week no-contact period.
For those in the active control group, the no-contact period will serve to wash out any placebo effect and Assessment 3 will be used as their new baseline.
These DPs will then be randomized to perception or memory training.
Assessments will then be given to these DPs within a week after intervention completion and after a 12 weeks no-contact period.
Study Type
Interventional
Enrollment (Estimated)
72
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 DeGutis, Ph.D.
- Phone Number: 510-734-7705
- Email: degutis@wjh.harvard.edu
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02130
- Recruiting
- VA Boston Healthcare System
-
Contact:
- Joseph M DeGutis, Ph.D.
- Phone Number: 510-734-7705
- Email: degutis@wjh.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
Description
Inclusion Criteria:
- Aged 18-90
- Have lifelong histories of face recognition difficulties that impact everyday life (i.e., not associated with some event such as a stroke, seizure, etc)
- Score > 2 standard deviations below the mean on the famous faces test and Cambridge Face Memory Test. This is in line with our previous studies and others in the literature.
Exclusion Criteria:
- 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.
- Participants 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).
- Participants will be excluded if they have impairments that interfere with cognitive performance, such as uncorrected hearing or vision, lack of English proficiency, musculoskeletal or other issues.
- Additionally, participants will be excluded if they have psychiatric disorders, such as schizophrenia, major depressive disorder, bipolar disorder, chronic intractable obsessive-compulsive disorder, or agoraphobia.
- Participants with a diagnosis of ADHD will be included as long as their medication has been consistent for the past 6 months.
- Participants who are currently dependent on alcohol or other substances will be excluded, as this may negatively impact cognitive performance.
- Participants who currently are, or within the last 6 months, participating in a behavioral or pharmacological intervention will be excluded.
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: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Memory Training
Participants will perform 6 weeks of face memory training (5 x 40 min sessions/week) that targets enhancing encoding to improve face recollection.
As training progresses, the repetition lags (spaces between repeated foil faces) and number of faces will increase.
|
Computer-based training using faces targeting face memory
|
|
Active Comparator: Perception Training
Participants will perform 6 weeks of face perception training (5 x 40 min sessions/week) that require discriminating faces based on internal features (e.g., eyebrow-eye distance).
As training progresses, the faces will become more challenging and the face sizes will vary.
|
Computer-based training using faces targeting improving face perception
|
|
Placebo Comparator: Active Control Training
Participants will perform 6 weeks of face perception training (5 x 40 min sessions/week) that require discriminating faces based on external facial features (e.g., hair).
As training progresses, the faces will become more challenging and the face sizes will vary.
|
Computer-based training using faces not targeting improving face perception or memory
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Cambridge Face Memory Test from baseline to post-training
Time Frame: baseline, within 2 weeks post-training (approximately 10 weeks after baseline), 12 weeks after training ends (approximately 22 weeks after baseline)
|
unfamiliar face learning/memory test, Cambridge Face Memory Test, minimum=0/maximum=72, higher is better performance
|
baseline, within 2 weeks post-training (approximately 10 weeks after baseline), 12 weeks after training ends (approximately 22 weeks after baseline)
|
|
Change in Face Perception from baseline to post-training
Time Frame: baseline, within 2 weeks post-training (approximately 10 weeks after baseline), 12 weeks after training ends (approximately 22 weeks after baseline)
|
computerized Benton Face Recognition Test, minimum=0/maximum=54, higher is better performance
|
baseline, within 2 weeks post-training (approximately 10 weeks after baseline), 12 weeks after training ends (approximately 22 weeks after baseline)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Face Recollection from baseline to post-training
Time Frame: baseline, within 2 weeks post-training (approximately 10 weeks after baseline), 12 weeks after training ends (approximately 22 weeks after baseline)
|
face recollection measure derived from old/new unfamiliar face recognition test
|
baseline, within 2 weeks post-training (approximately 10 weeks after baseline), 12 weeks after training ends (approximately 22 weeks after baseline)
|
|
Change in Self-reported face recognition ability from baseline to post-training
Time Frame: baseline, within 2 weeks post-training (approximately 10 weeks after baseline),12 weeks after training ends (approximately 22 weeks after baseline)
|
items assessing everyday face recognition, minimum=0/maximum=100, higher is better
|
baseline, within 2 weeks post-training (approximately 10 weeks after baseline),12 weeks after training ends (approximately 22 weeks after baseline)
|
|
Change in Eye processing ability from baseline to post-training
Time Frame: baseline, within 2 weeks post-training (approximately 10 weeks after baseline), 12 weeks after training ends (approximately 22 weeks after baseline)
|
average eye processing ability from Georges task
|
baseline, within 2 weeks post-training (approximately 10 weeks after baseline), 12 weeks after training ends (approximately 22 weeks after baseline)
|
|
Change in Holistic processing from baseline to post-training
Time Frame: baseline, within 2 weeks post-training (approximately 10 weeks after baseline), 12 weeks after training ends (approximately 22 weeks after baseline)
|
measure of holistic processing of faces (holistic advantage) from part-whole task
|
baseline, within 2 weeks post-training (approximately 10 weeks after baseline), 12 weeks after training ends (approximately 22 weeks after baseline)
|
|
Change in NIH PROMIS Social functioning self-report from baseline to post-training
Time Frame: baseline, within 2 weeks post-training (approximately 10 weeks after baseline), 12 weeks after training ends (approximately 22 weeks after baseline)
|
bank of NIH PROMIS items asking about social functioning related to prosopagnosia, minimum=0/maximum=100, higher is better
|
baseline, within 2 weeks post-training (approximately 10 weeks after baseline), 12 weeks after training ends (approximately 22 weeks after baseline)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Joseph DeGutis, Ph.D., Harvard Medical School/VA Boston Healthcare Systems
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)
October 15, 2023
Primary Completion (Estimated)
February 1, 2025
Study Completion (Estimated)
February 21, 2025
Study Registration Dates
First Submitted
February 21, 2023
First Submitted That Met QC Criteria
April 4, 2023
First Posted (Actual)
April 6, 2023
Study Record Updates
Last Update Posted (Actual)
January 12, 2024
Last Update Submitted That Met QC Criteria
January 10, 2024
Last Verified
March 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R01EY032510-02 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
De-identified individual participant data will be made available to other researchers in accordance with the VA Boston Healthcare System IRB and Privacy/Security policies
IPD Sharing Time Frame
Once the VA Boston Healthcare System IRB approves sharing this information
IPD Sharing Access Criteria
The VA Boston Healthcare System IRB will also establish access criteria
IPD Sharing Supporting Information Type
- ANALYTIC_CODE
- CSR
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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