Remote Monitoring and Detecting of Tardive Dyskinesia for Improving Patient Outcomes

Last updated: March 7, 2024
Sponsor: iRxReminder
Overall Status: Active - Recruiting

Phase

N/A

Condition

Dyskinesias

Tardive Dyskinesia

Treatment

TDtect

Clinical Study ID

NCT06011408
#23-002
R43MH114763
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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

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 apatient from completing the TD protocol.
  3. Severe visual impairment that is cannot be corrected by glasses or contacts.

Study Design

Total Participants: 300
Treatment Group(s): 1
Primary Treatment: TDtect
Phase:
Study Start date:
May 30, 2023
Estimated Completion Date:
December 31, 2024

Study 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.

Connect with a study center

  • Fermata Helath

    Brooklyn, New York 10038
    United States

    Active - Recruiting

  • Charak Research Center

    Garfield Heights, Ohio 44125
    United States

    Active - Recruiting

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