Remote Monitoring and Detecting of Tardive Dyskinesia for Improving Patient Outcomes

Not Applicable

Recruiting

• Conditions: Tardive Dyskinesia
• Interventions: Other: TDtect

• Registration Number: NCT06011408
• Lead Sponsor: iRxReminder

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2023-05-30
• Study First Submitted: 2023-08-21
• Study First Submitted QC: 2023-08-21
• Study First Posted: 2023-08-25
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-07
• Last Update Posted: 2024-03-12
• Primary Completion: 2024-11-30
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Taking antipsychotic medication with Tardive Dyskinesia	TDtect	-
Taking antipsychotic medication without Tardive Dyskinesia	TDtect	-

Primary Outcome Measures

Name	Time	Method
AIMS Score	Baseline	Abnormal Involuntary Scale Score

Trial Locations

Locations (2)

Charak Research Center; 🇺🇸 Garfield Heights, Ohio, United States

Fermata Helath; 🇺🇸 Brooklyn, New York, United States