Remote Monitoring and Detecting of Tardive Dyskinesia for Improving Patient Outcomes

March 7, 2024 updated by: iRxReminder
The study is being conducted to validate the feasibility of remote assessment of Tardive Dyskinesia.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • New York
      • Brooklyn, New York, United States, 10038
        • Recruiting
        • Fermata Helath
        • Principal Investigator:
          • Owen Muir, M.D.
        • Contact:
    • Ohio
      • Garfield Heights, Ohio, United States, 44125
        • Recruiting
        • Charak Research Center
        • Contact:
        • Principal Investigator:
          • Rakesh Ranjan, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Taking antipsychotic medication with Tardive Dyskinesia
Other: TDtect
Collecting video data on abnormal movement
Other: Taking antipsychotic medication without Tardive Dyskinesia
Other: TDtect
Collecting video data on abnormal movement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AIMS Score
Time Frame: Baseline
Abnormal Involuntary Scale Score
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

iRxReminder

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Study Director: Rakesh Ranjan, M.D., Charak Research Center
  • Study Director: Owen Muir, M.D., Fermata Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 30, 2023

Primary Completion (Estimated)

November 30, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

August 21, 2023

First Submitted That Met QC Criteria

August 21, 2023

First Posted (Actual)

August 25, 2023

Study Record Updates

Last Update Posted (Actual)

March 12, 2024

Last Update Submitted That Met QC Criteria

March 7, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • #23-002
  • R43MH114763 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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