Remote Monitoring and Detecting of Tardive Dyskinesia for Improving Patient Outcomes

Status

Recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06011408

Enrollment

300

Registered

2023-08-25

Start date

2023-05-30

Completion date

2024-12-31

Last updated

2024-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tardive Dyskinesia

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.

Interventions

OTHERTDtect

Collecting video data on abnormal movement

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SCREENING

Masking

NONE

Intervention model description

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

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
AIMS Score	Baseline	Abnormal Involuntary Scale Score

Countries

United States

Contacts

Primary ContactAnthony Sterns, Ph.D.

asterns@irxreminder.com3306066675

Backup ContactFred Ma, M.D., Ph.D.

fma@irxreminder.com2164695725

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026