Remote Monitoring and Detecting of Tardive Dyskinesia for Improving Patient Outcomes

iRxReminder

Status: Enrolling

Conditions: Tardive Dyskinesia

Treatments: Other: TDtect

Study type: Interventional

Funder types: Industry; NIH

Identifiers

NCT06011408

R43MH114763 (U.S. NIH Grant/Contract)

#23-002

Details and patient eligibility

About

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

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

Taking antipsychotic medication with Tardive Dyskinesia

Other group

Treatment:

Other: TDtect

Taking antipsychotic medication without Tardive Dyskinesia

Other group

Treatment:

Other: TDtect