Clinical trial NCT05800782: Face Perception vs. Memory Training to Improve Face Recognition in Developmental Prosopagnosia
Official title: Examining the Effectiveness of Face Perception and Memory Training to Improve Face Recognition in Developmental Prosopagnosia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Developmental Prosopagnosia
Lead sponsor: Boston VA Research Institute, Inc.
Sponsor class: OTHER
First posted: 2023-04-06
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Cambridge Face Memory Test from baseline to post-training
timeFrame: baseline, within 2 weeks post-training (approximately 10 weeks after baseline), 12 weeks after training ends (approximately 22 weeks after baseline)
measure: Change in Face Perception from baseline to post-training
timeFrame: baseline, within 2 weeks post-training (approximately 10 weeks after baseline), 12 weeks after training ends (approximately 22 weeks after baseline)
Secondary outcomes:
measure: Change in Face Recollection from baseline to post-training
timeFrame: baseline, within 2 weeks post-training (approximately 10 weeks after baseline), 12 weeks after training ends (approximately 22 weeks after baseline)
measure: Change in Self-reported face recognition ability from baseline to post-training
timeFrame: baseline, within 2 weeks post-training (approximately 10 weeks after baseline),12 weeks after training ends (approximately 22 weeks after baseline)
measure: Change in Eye processing ability from baseline to post-training
timeFrame: baseline, within 2 weeks post-training (approximately 10 weeks after baseline), 12 weeks after training ends (approximately 22 weeks after baseline)
measure: Change in Holistic processing from baseline to post-training
timeFrame: baseline, within 2 weeks post-training (approximately 10 weeks after baseline), 12 weeks after training ends (approximately 22 weeks after baseline)
measure: Change in NIH PROMIS Social functioning self-report from baseline to post-training
timeFrame: baseline, within 2 weeks post-training (approximately 10 weeks after baseline), 12 weeks after training ends (approximately 22 weeks after baseline)
Other outcomes:
Locations:
city: Boston
country: United States
facility: VA Boston Healthcare System
state: Massachusetts
Study officials:
affiliation: Harvard Medical School/VA Boston Healthcare Systems
name: Joseph DeGutis, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: