Remote Monitoring and Detecting of Tardive Dyskinesia for Improving Patient Outcomes

Tardive Dyskinesia Clinical Trial

Official title:

Remote Monitoring and Detecting of Tardive Dyskinesia for Improving Patient Outcomes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06011408
• Other study ID #: #23-002
• Secondary ID: R43MH114763
• Status: Recruiting
• Phase: N/A
• Start date: May 30, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2024
• Source: iRxReminder
• Contact: Anthony Sterns, Ph.D.
• Phone: 3306066675
• Email: asterns[@]irxreminder.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study is being conducted to validate the feasibility of remote assessment of Tardive Dyskinesia.

Description:

The study is being conducted to validate the feasibility of remote assessment of Tardive Dyskinesia. Participants will all be taking an antipsychotic medication and half will have a diagnosis of Tardive Dyskinesia and half will not. Participant responses to interview questions and elements of the Abnormal Involuntary Movement Scale will be collected on video. The videos will be rated by trained observers. Machine learning methods will be used to develop an algorithm to detect abnormal movements in individuals with a known Tardive Dyskinesia diagnosis. The trained rater results will be compared to the algorithm to determine the accuracy of the algorithm.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 31, 2024
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

For the non-TD group:

1. Prescribed and taking an antipsychotic medication for 90-days or longer.

2. Tardive Dyskinesia symptoms if present are not from Parkinsons, Tourette's syndrome, Huntington disease.

3. Signed an informed consent.

4. Speaks English fluently.

Exclusion Criteria:

1. Suffered a moderate or severe head injury in the last year;

2. History of a learning disorder or developmental disability that would inhibit a patient from completing the TD protocol.

3. Severe visual impairment that is cannot be corrected by glasses or contacts.

Related Conditions & MeSH terms

• Dyskinesias
• Tardive Dyskinesia

Intervention

Other:
• TDtect
Collecting video data on abnormal movement

Locations

Country	Name	City	State
United States	Fermata Helath	Brooklyn	New York
United States	Charak Research Center	Garfield Heights	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
iRxReminder	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AIMS Score	Abnormal Involuntary Scale Score	Baseline

External Links

•   Related Info
•   Related Info
•   Related Info