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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
72

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02130
        • Recruiting
        • VA Boston Healthcare System
        • Contact:

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: Face Memory Training
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.
Behavioral: Face Perception Training
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.
Behavioral: Placebo control training
Computer-based training using faces not targeting improving face perception or memory

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boston VA Research Institute, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 15, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 21, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 21, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 4, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 6, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 12, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 10, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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