Developmental ProsopagnosiaNCT05800782
Face Perception vs. Memory Training to Improve Face Recognition in Developmental Prosopagnosia
A study testing Face Memory Training and Face Perception Training in people with Developmental Prosopagnosia, run by Boston VA Research Institute, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Developmental Prosopagnosia
- What is being tested?
- Face Memory Training and Face Perception Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2023to 21 Feb 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
VA Boston Healthcare System
Boston, Massachusetts, 02130
Joseph M DeGutis, Ph.D., 510-734-7705, degutis@wjh.harvard.edu
About this study
Official title: 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.
Read the 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.
- Conditions
- Developmental Prosopagnosia
- Being tested
- Face Memory Training, Face Perception Training, Placebo control training
- Medical subject headings
- Prosopagnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Face Memory TrainingBehavioural
Computer-based training using faces targeting face memory
Face Perception TrainingBehavioural
Computer-based training using faces targeting improving face perception
Placebo control trainingBehavioural
Computer-based training using faces not targeting improving face perception or memory
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Behavioral: Placebo control training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
face recollection measure derived from old/new unfamiliar face recognition test
Measured: 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
items assessing everyday face recognition, minimum=0/maximum=100, higher is better
Measured: 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
average eye processing ability from Georges task
Measured: 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
measure of holistic processing of faces (holistic advantage) from part-whole task
Measured: 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
bank of NIH PROMIS items asking about social functioning related to prosopagnosia, minimum=0/maximum=100, higher is better
Measured: baseline, within 2 weeks post-training (approximately 10 weeks after baseline), 12 weeks after training ends (approximately 22 weeks after baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2023
- Study start15 Oct 2023
- Primary completion1 Feb 2025 (estimated)
- Study completion21 Feb 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
- Model description
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston VA Research Institute, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joseph DeGutis, Ph.D., Principal investigator, Harvard Medical School/VA Boston Healthcare Systems
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05800782
- Sponsor's protocol ID
- R01EY032510-02
- Status last verified
- Mar 2023
- First submitted
- 21 Feb 2023
- Last updated
- 12 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Effectiveness of Face Perception and Memory Training to Improve Face Recognition in Developmental Prosopagnosia
- ClinicalTrials.gov ID
- NCT05800782
- Acronym / sponsor ID
- R01EY032510-02
- Conditions
- Developmental Prosopagnosia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Boston VA Research Institute, Inc.University, hospital or other
- Study start
- 15 Oct 2023 (actual)
- Primary completion
- 1 Feb 2025 (estimated)
- Study completion
- 21 Feb 2025 (estimated)
- First posted
- 6 Apr 2023 (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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Memory Training | Experimental | Behavioral: Face Memory TrainingParticipants 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. |
| Perception Training | Active comparator | Behavioral: Face Perception TrainingParticipants 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. |
| Active Control Training | Placebo comparator | Behavioral: Placebo control trainingParticipants 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
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 |
|---|---|---|
| Face Memory TrainingComputer-based training using faces targeting face memory | Behavioural | Memory Training |
| Face Perception TrainingComputer-based training using faces targeting improving face perception | Behavioural | Perception Training |
| Placebo control trainingComputer-based training using faces not targeting improving face perception or memory | Behavioural | Active Control Training |
Primary outcome
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
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
5 secondary outcomes
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)
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)
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)
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)
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2024.
- Individual participant dataSharing planned: Yes. 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
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.
Joseph DeGutis, Ph.D. principal investigator
Harvard Medical School/VA Boston Healthcare Systems
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Face Memory Training and Face Perception 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 3 inclusion and 7 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 12 Jan 2024. 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. Some participants in this study may receive a placebo. 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 DeGutis, Ph.D. (510-734-7705, degutis@wjh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 2 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 12 Jan 2024.