NCT07008989

Brief Summary

Down syndrome is a chromosomal abnormality associated with significant deficits across multiple cognitive domains, including a disproportionate deficit in hippocampally-dependent memory. In other words, individuals with Down syndrome may have a particular difficulty remembering specific details from past events. One way this manifests itself is in overgeneral autobiographical memory, or a tendency to remember the general gist of an event or cluster of events, rather than a single, isolated event. This overgeneral memory makes it difficult for individuals with Down syndrome to access their past, can interfere with attempts to becoming more independent, and increases anxiety and depression. In the current VIRTUAL study, the investigators test whether a new digital memory prosthetic-HippoCamera-can enhance specific autobiographical memory in individuals with Down syndrome. In HippoCamera, users are asked to record and replay events from their daily lives. This replay is curated by a research-based algorithm in HippoCamera that optimizes consolidation of these events over time and has been shown to enhance memory specificity in other populations with memory impairments, particularly those that stem from hippocampal disfunction. It is, therefore, likely that similar enhancements in autobiographical memory specificity will be identified in individuals with Down syndrome, highlighting the benefits of this applications in this population.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
3mo left

Started Jun 2025

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress80%
Jun 2025Jul 2026

First Submitted

Initial submission to the registry

May 27, 2025

Completed
5 days until next milestone

Study Start

First participant enrolled

June 1, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 6, 2025

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2026

Last Updated

June 19, 2025

Status Verified

June 1, 2025

Enrollment Period

1.2 years

First QC Date

May 27, 2025

Last Update Submit

June 16, 2025

Conditions

Keywords

Down syndromememoryhippocampustechnology

Outcome Measures

Primary Outcomes (1)

  • Internal detail

    All memory narratives will be transcribed and scored using the Autobiographical Interview protocol. Highly trained raters will score each autobiographical memory according to the number and proportion of episodic (internal) vs. semantic (external) details. Episodic details are specific to the time and place of the targeted event, whereas semantic details involve factual information or extended events that do not require recollection of a specific time and place. Memory for episodic details requires the hippocampus, whereas memory for semantic details is more resistant to hippocampal damage.

    Baseline memory appointment (immediately prior to intervention), immediate post-treatment appointment (within a week of terminating intervention), and follow-up appointment (6 weeks after terminating intervention).

Secondary Outcomes (3)

  • Positive memory content

    Baseline memory appointment (immediately prior to intervention), immediate post-treatment appointment (within a week of terminating intervention), and follow-up appointment (6 weeks after terminating intervention).

  • Independence

    Baseline memory appointment (immediately prior to intervention), immediate post-treatment appointment (within a week of terminating intervention), and follow-up appointment (6 weeks after terminating intervention).

  • Positive and Negative mood

    Baseline memory appointment (immediately prior to intervention), immediate post-treatment appointment (within a week of terminating intervention), and follow-up appointment (6 weeks after terminating intervention).

Study Arms (2)

Immediate intervention

EXPERIMENTAL

During the first 12 weeks following enrollment, the Immediate Intervention group will engage in daily practice with the HippoCamera app. HippoCamera is a smartphone application that allows participants to record and replay important events in their daily lives. Based on principles from psychology and neuroscience, engaging in this daily practice may increase focus on memory-orientated practices in participants.

Behavioral: Memory replay

Delayed Intervention

OTHER

During the first 12 weeks following enrollment, the Delayed Intervention group will serve as a control, receiving no intervention. After the initial 12 weeks, they will be entered into daily engagement with the HippoCamera app.

Behavioral: Memory replay

Interventions

Memory replayBEHAVIORAL

Within the HippoCamera application, half of all recorded events will be categorized as "baseline" memories, and half will be categorized as "replay" memories. Baseline memories are recorded, but never viewed by the participant again until the "Early HippoCamera" test at the end of the 12-week intervention. Replay memories are recorded, and then placed into a memory gallery. HippoCamera uses a research-based algorithm to select 5 memories from this gallery for participants to replay each day. Prior research has shown that this replay is associated with significant memory enhancements for replayed v. baseline memories for HippoCamera users from other populations.

Delayed InterventionImmediate intervention

Eligibility Criteria

Age15 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Diagnosis of Down syndrome
  • Daily access to a smart phone
  • The ability to create and replay memories using HippoCamera with limited support from a guardian
  • Informed consent obtained from parent or guardian (or participant, if legally independent)
  • Informed verbal assent obtained from participant
  • Ability to comprehend instructions, denoted by parent/guardian acknowledgment
  • English as a primary written and spoken language
  • Normal or corrected-to-normal vision and hearing
  • All races/ethnicities and socio-economic statuses

You may not qualify if:

  • Autism
  • Non-native speaker of English (acquired after the age of 5)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boston College ONLINE STUDY

Chestnut Hill, Massachusetts, 02467, United States

RECRUITING

MeSH Terms

Conditions

Down Syndrome

Condition Hierarchy (Ancestors)

Intellectual DisabilityNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesAbnormalities, MultipleCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesChromosome DisordersGenetic Diseases, Inborn

Central Study Contacts

Jaclyn Ford, PhD

CONTACT

Lauren Voso, BS

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: Following a baseline screening and memory test, participants will be randomly assigned to one group. During the first 12 weeks, one group will be assigned to the HippoCamera intervention and the other will serve as a control, receiving no intervention. After the first 12 weeks, the second group will receive the HippoCamera intervention. Within the HippoCamera application, half of all recorded events will be categorized as "baseline" memories, and half will be categorized as "replay" memories. Baseline memories are recorded, but never viewed by the participant again until the test at the end of the 12-week intervention. Replay memories are recorded, and then placed into a memory gallery. HippoCamera uses a research-based algorithm to select 5 memories from this gallery for participants to replay each day. Prior research has shown that this replay is associated with significant memory enhancements for replayed v. baseline memories for HippoCamera users from other populations.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 27, 2025

First Posted

June 6, 2025

Study Start

June 1, 2025

Primary Completion (Estimated)

July 31, 2026

Study Completion (Estimated)

July 31, 2026

Last Updated

June 19, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will share

All data will be anonymized prior to sharing. De-identified data from surveys will consist of tab-delimited output from the programs running the tasks. These data will be exported to a format that can be shared with researchers with either Macintosh or Windows platforms (e.g., .xls or .txt format). These files are small and should easily be able to be shared electronically with interested researchers, via email or secure servers. Videos and transcribed narratives of memories will not be shared, but scored data (e.g., detail and positivity scores) for each memory will be easily de-identified and saved as an excel file on a secure server. These de-identified scored data files will be small and should easily be able to be shared electronically with interested researchers, via email or secure servers.

Shared Documents
STUDY PROTOCOL, SAP, ANALYTIC CODE
Time Frame
Deidentified data will be available for access and sharing with interested researchers as soon as the final version of the manuscript is accepted for publication.
Access Criteria
Survey data and autobiographical memory scores will be uploaded to a public database (e.g., OSF) in conjunction with each publication.

Locations