NCT04799340

Brief Summary

This study will examine the effectiveness of a cognitive training intervention targeting face recollection, repetition lag training, at improving face recognition in Developmental Prosopagnosia.

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
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2021

Longer than P75 for not_applicable

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 11, 2021

Completed
1 day until next milestone

Study Start

First participant enrolled

March 12, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 16, 2021

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

November 29, 2022

Status Verified

November 1, 2022

Enrollment Period

4.2 years

First QC Date

March 11, 2021

Last Update Submit

November 23, 2022

Conditions

Developmental Prosopagnosia

Outcome Measures

Primary Outcomes (3)

  • Cambridge Face Memory Test

    learning and recognizing novel faces, out of 72 (higher score is better)

    15 minutes

  • Face Recollection

    old/new face recognition test, extracting familiarity and recollection parameters, higher score is better

    15 minutes

  • Face Perception

    composite of face matching tasks, Cambridge Face perception Test and computerized Benton, higher score is better

    30 minutes

Secondary Outcomes (2)

  • Self-reported face recognition

    5 minutes

  • Face-name learning task

    15 minutes

Study Arms (2)

holistic face training + repetition lag training

EXPERIMENTAL
Behavioral: cognitive training

waitlist control

NO INTERVENTION

Interventions

cognitive trainingBEHAVIORAL

training to improve encoding and recognition of faces

holistic face training + repetition lag training

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Boston Healthcare System, 150 S. Huntington Ave.

Boston, Massachusetts, 02130, United States

RECRUITING

MeSH Terms

Conditions

Prosopagnosia

Interventions

Cognitive Training

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Neurological RehabilitationRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Central Study Contacts

Joseph M DeGutis, Ph.D.

CONTACT

510-734-7705degutis@hms.harvard.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 11, 2021

First Posted

March 16, 2021

Study Start

March 12, 2021

Primary Completion

May 31, 2025

Study Completion

July 1, 2025

Last Updated

November 29, 2022

Record last verified: 2022-11

Locations

US(1)