Remote monitoring to assess Tardive Dyskinesia symptoms

Remote Monitoring and Detecting of Tardive Dyskinesia for Improving Patient Outcomes

This study is testing if remote video assessments can help doctors better understand Tardive Dyskinesia symptoms in people taking antipsychotic medications.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 300 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: iRxReminder (Industry-sponsored)
• Locations: 2 sites (Brooklyn, New York and 1 other locations)
• Trial ID: NCT06011408 on ClinicalTrials.gov

What this trial studies

This study aims to validate the feasibility of remotely assessing Tardive Dyskinesia in patients taking antipsychotic medications. Participants will be divided into two groups: those diagnosed with Tardive Dyskinesia and those without. Their responses to interview questions and assessments using the Abnormal Involuntary Movement Scale will be recorded on video. Trained observers will rate these videos, and machine learning algorithms will be developed to detect abnormal movements, comparing the algorithm's accuracy to that of the trained raters.

Who should consider this trial

Good fit: Ideal candidates include individuals prescribed antipsychotic medications for at least 90 days, with or without a diagnosis of Tardive Dyskinesia.

Not a fit: Patients with moderate to severe head injuries, learning disorders, or severe uncorrectable visual impairments may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to improved monitoring and management of Tardive Dyskinesia, enhancing patient outcomes.

How similar studies have performed: While remote monitoring is a growing field, this specific approach to Tardive Dyskinesia assessment is novel and has not been extensively tested in prior studies.

Eligibility criteria

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.

Where this trial is running

Brooklyn, New York and 1 other locations

• Fermata Helath — Brooklyn, New York, United States (Recruiting)
• Charak Research Center — Garfield Heights, Ohio, United States (Recruiting)

Study contacts

• Study coordinator: Anthony Sterns, Ph.D.

Conditions Tardive Dyskinesia