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NCT05637697 Clinical Trial

Angelman Syndrome Video Assessment (ASVA) Source Material Study

Angelman Syndrome Clinical Trial

— ASVA SMS  

Official title:
Angelman Syndrome Video Assessment (ASVA) Source Material Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05637697
Other study ID # CAS-CAS006
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 31, 2021
Est. completion date August 1, 2023

Study information
Verified date December 2023
Source The Emmes Company, LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This is a longitudinal, observational, nonrandomized, fully remote study enrolling approximately 55 participant-caregiver dyads. The study includes no treatments or interventions, and participants will not be asked to change their current treatments. The objective of this study is to gather sufficient source material videos to develop a scoring system for ASVA and to perform preliminary validation of that scoring system.

Recruitment information / eligibility
Status Completed
Enrollment 73
Est. completion date August 1, 2023
Est. primary completion date August 1, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 1 Year and older
Eligibility - Caregiver reports that the individual with AS has a laboratory-confirmed diagnosis of Angelman syndrome - Individual with AS is at least 1 year old - Caregiver is willing and able to provide informed consent for themselves and oversee study participation - Caregiver or legal guardian is willing to provide informed consent on behalf of the individual with AS - Caregiver is comfortable reading and speaking in English - Caregiver has access to a smartphone or tablet that is compatible with the study app OR caregiver has internet access and is willing to use a wi-fi only device to record and upload videos NT-Caregiver dyads will be eligible for inclusion if the: - Neurotypical individual is between 1 and 8 years of age - Caregiver is willing and able to provide informed consent and oversee study participation and NT individual is willing and able to provide assent, as applicable - Caregiver is comfortable reading and speaking in English - Caregiver has access to a smartphone or tablet that is compatible with the study app OR caregiver has internet access and is willing to use a wi-fi only device to record and upload videos Participant-Caregiver dyads will be excluded from the study only if they do not meet the inclusion criteria above.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Casimir Kingston Massachusetts

Sponsors (3)
Lead Sponsor Collaborator
The Emmes Company, LLC Boston Children's Hospital, Ionis Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Source material collection, Baseline The objective of this study is to gather sufficient source material videos to develop a scoring system for ASVA and to perform preliminary validation of that scoring system. Baseline
Primary Source material collection, Week 12 The objective of this study is to gather sufficient source material videos to develop a scoring system for ASVA and to perform preliminary validation of that scoring system. Week 12
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