Remote Monitoring and Detecting of Tardive Dyskinesia for Improving Patient Outcomes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-30

Study Completion Date

2024-12-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Tardive Dyskinesia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Open-label, observational study with two groups taking antipsychotic with or without Tardive Dyskinesia

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Taking antipsychotic medication with Tardive Dyskinesia

Group Type OTHER

TDtect

Intervention Type OTHER

Collecting video data on abnormal movement

Taking antipsychotic medication without Tardive Dyskinesia

Group Type OTHER

TDtect

Intervention Type OTHER

Collecting video data on abnormal movement

Interventions

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TDtect

Collecting video data on abnormal movement

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No