A VIRTUAL Three-month Intervention Study of the Effects of a Smartphone Application (HippoCamera) on Memory in Teens and Young Adults With Down Syndrome

June 16, 2025 updated by: Boston College

Use of a Digital Memory Prosthetic to Support Autobiographical Memory in Down Syndrome

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Individuals with Down syndrome exhibit a disproportionate deficit in hippocampally-dependent memory, including a particular difficulty remembering event-specific details of events from their own lives (i.e., autobiographical memory). In the proposed research, the investigators test the efficacy of a digital memory prosthetic-the HippoCamera application-in supporting this specific autobiographical memory in individuals with Down syndrome. In HippoCamera, participants are asked to record one event each day and replay up to five recorded events from prior days. This replay is curated by a research-based algorithm in HippoCamera that optimizes consolidation of these events over time. HippoCamera replay has been shown to enhance memory specificity in other populations with memory impairments, particularly those that stem from hippocampal disfunction. Specifically, memories that were replayed during the intervention were remembered with greater specificity than those that were just recorded and not replayed. The current research attempts to extend these findings by showing memory enhancements in a population with intellectual disabilities. Specifically, there are two independent aims:

Goal 1: Does using HippoCamera to record and replay daily events lead to greater memory specificity for the replayed events? To test the efficacy of HippoCamera in enhancing replayed memories, the current study compares memory for replayed and not replayed events in a sample of 40 individuals with Down syndrome. All participants enrolled in the study will take part in this intervention, allowing a within-subject comparison of replayed vs. not replayed events. This difference will be tested at two points: immediately (right after the 12-week intervention) and delayed (6 weeks after the 12-week intervention).

Goal 2: Does using HippoCamera to record and replay daily events help participants to develop memory-oriented strategies and behaviors that lead to global memory improvements?

It is possible that the greater benefit of HippoCamera is a global memory enhancement for all autobiographical memories in individuals who complete the intervention. To explore global memory benefits, the 40 participants will be pseudo-randomly assigned to one of two intervention groups (20 each in Groups A and B; pseudo-randomized to ensure matching of age, education, and baseline memory performance).

Critically, although all participants will eventually take part in the intervention, Group B will have a delayed start. In other words, all participants will complete the baseline memory test at the time of enrollment, then participants in Group A will immediately begin the intervention while participants in Group B will serve as a no-intervention control. At the end of Group A's 12-week intervention, both groups will complete a follow-up memory test.

Baseline-to-follow-up increases in memory specificity in Group A (i.e., intervention arm) will be compared to the same increases in Group B (i.e., control arm); greater increases in Group A could then be attributed to their enrollment in the 12-week intervention).

After serving as the control group for Group A's 12-week intervention, Group B will then begin the intervention.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Lauren Voso, BS
  • Phone Number: (617) 552-6949

Study Locations

  • United States
    • Massachusetts
      • Chestnut Hill, Massachusetts, United States, 02467
        • Recruiting
        • Boston College ONLINE STUDY
        • Contact:
          • Lauren Voso, BS
          • Phone Number: (617) 552-6949
          • Email: canlab@bc.edu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Immediate intervention
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

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.
Other: Delayed Intervention
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

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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Internal detail
Time Frame: 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).

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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Positive memory content
Time Frame: 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).
All memory narratives will be transcribed and scored using a text-based sentiment analysis (Valence Aware Dictionary and sEntiment Reasoner; VADER). VADER uses natural language processing to generate a weighted composite score of each narrative's overall sentiment between -1 (highly negative) to +1 (highly positive).
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
Time Frame: 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).
Researchers will ask guardians to complete a brief survey describing participant independence. This survey will include questions about activities outside the house (e.g., work or school), social networks, and ability to perform self-care activities (e.g., feeding, dressing, etc.) independently. This survey will have a range of 0-20, with 20 indicating greater 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
Time Frame: 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).
Participants will complete the Positive and Negative Affective Schedule (PANAS), a measure of positive and negative affect that has previously been used to evaluate mood in intellectual disability. The PANAS is a 20-item self-report questionnaire with 10 positive affect feelings/emotions and 10 negative affect feelings/emotions with possible scores ranging from (lowest) 20 to (highest) 100.
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).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boston College

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Colorado, Denver
Massachusetts General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 27, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 5, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 6, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 19, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 16, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1R21HD114263 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing 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.

IPD Sharing Access Criteria

Survey data and autobiographical memory scores will be uploaded to a public database (e.g., OSF) in conjunction with each publication.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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