NCT05800782

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2023

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

February 21, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 6, 2023

Completed
6 months until next milestone

Study Start

First participant enrolled

October 15, 2023

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2025

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 21, 2025

Completed
Last Updated

January 12, 2024

Status Verified

March 1, 2023

Enrollment Period

1.3 years

First QC Date

February 21, 2023

Last Update Submit

January 10, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • Change in Cambridge Face Memory Test from baseline to post-training

    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

    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 Outcomes (5)

  • Change in Face Recollection from baseline to post-training

    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

    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

    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

    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

    baseline, within 2 weeks post-training (approximately 10 weeks after baseline), 12 weeks after training ends (approximately 22 weeks after baseline)

Study Arms (3)

Memory Training

EXPERIMENTAL

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

Perception Training

ACTIVE COMPARATOR

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

Active Control Training

PLACEBO COMPARATOR

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

Interventions

Computer-based training using faces targeting face memory

Memory Training

Computer-based training using faces targeting improving face perception

Perception Training

Computer-based training using faces not targeting improving face perception or memory

Active Control Training

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Boston Healthcare System

Boston, Massachusetts, 02130, United States

RECRUITING

MeSH Terms

Conditions

Prosopagnosia

Condition Hierarchy (Ancestors)

AgnosiaPerceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Joseph DeGutis, Ph.D.

    Harvard Medical School/VA Boston Healthcare Systems

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Joseph DeGutis, Ph.D.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants will not be told whether they are in the experimental or control conditions and all conditions will require discriminating faces.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: There will be a pre assessment, 6 weeks of training/active control, then an immediate post assessment, and finally an assessment after a 12-week no-contact period
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 21, 2023

First Posted

April 6, 2023

Study Start

October 15, 2023

Primary Completion

February 1, 2025

Study Completion

February 21, 2025

Last Updated

January 12, 2024

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will share

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

Shared Documents
CSR, ANALYTIC CODE
Time Frame
Once the VA Boston Healthcare System IRB approves sharing this information
Access Criteria
The VA Boston Healthcare System IRB will also establish access criteria

Locations