Developmental ProsopagnosiaNCT04799340
Computer-based Training of Face Recollection to Improve Face Recognition in Developmental Prosopagnosia
A study testing cognitive training in people with Developmental Prosopagnosia, run by Boston VA Research Institute, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Developmental Prosopagnosia
- What is being tested?
- cognitive training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Mar 2021to 1 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
VA Boston Healthcare System, 150 S. Huntington Ave.
Boston, Massachusetts, 02130
Joseph M DeGutis, Ph.D., 510-734-7705, degutis@hms.harvard.edu
About this study
Official title: 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.
- Conditions
- Developmental Prosopagnosia
- Being tested
- cognitive training
- Medical subject headings
- Prosopagnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cognitive trainingBehavioural
training to improve encoding and recognition of faces
| Study group | Role | What they receive |
|---|---|---|
| holistic face training + repetition lag training | Experimental | Not described Receives: Behavioral: cognitive training |
| waitlist control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cambridge Face Memory Test
learning and recognizing novel faces, out of 72 (higher score is better)
Measured: 15 minutes
Face Recollection
old/new face recognition test, extracting familiarity and recollection parameters, higher score is better
Measured: 15 minutes
Face Perception
composite of face matching tasks, Cambridge Face perception Test and computerized Benton, higher score is better
Measured: 30 minutes
Secondary outcomes (2)
Self-reported face recognition
questionnaire
Measured: 5 minutes
Face-name learning task
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2021
- Study start12 Mar 2021
- Primary completion31 May 2025 (estimated)
- Study completion1 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Developmental ProsopagnosiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston VA Research Institute, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joseph DeGutis, Harvard Medical School (HMS and HSDM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04799340
- Sponsor's protocol ID
- R21EY031000, R01EY032510
- Other IDs
- R21EY031000
- Status last verified
- Nov 2022
- First submitted
- 11 Mar 2021
- Last updated
- 29 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterizing and Remediating Recollection-specific Face Recognition Deficits in Developmental Prosopagnosia
- ClinicalTrials.gov ID
- NCT04799340
- Acronym / sponsor ID
- R21EY031000, R01EY032510
- Conditions
- Developmental Prosopagnosia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Boston VA Research Institute, Inc.University, hospital or other
- Study start
- 12 Mar 2021 (actual)
- Primary completion
- 31 May 2025 (estimated)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 16 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| holistic face training + repetition lag training | Experimental | Behavioral: cognitive training |
| waitlist control | No intervention | – |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cognitive trainingtraining to improve encoding and recognition of faces | Behavioural | holistic face training + repetition lag training |
Primary outcome
Cambridge Face Memory Test
Time frame: 15 minutes
learning and recognizing novel faces, out of 72 (higher score is better)
Face Recollection
Time frame: 15 minutes
old/new face recognition test, extracting familiarity and recollection parameters, higher score is better
Face Perception
Time frame: 30 minutes
composite of face matching tasks, Cambridge Face perception Test and computerized Benton, higher score is better
2 secondary outcomes
Self-reported face recognition
Time frame: 5 minutes
Face-name learning task
Time frame: 15 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2022.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cognitive training in people with Developmental Prosopagnosia, run by Boston VA Research Institute, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joseph M DeGutis, Ph.D. (510-734-7705, degutis@hms.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cambridge Face Memory Test (time frame: 15 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2022.