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Clinical Trials/NCT06011408
NCT06011408
Recruiting
N/A

Remote Monitoring and Detecting of Tardive Dyskinesia for Improving Patient Outcomes

iRxReminder2 sites in 1 country300 target enrollmentMay 30, 2023

Overview

Phase
N/A
Intervention
Not specified
Conditions
Tardive Dyskinesia
Sponsor
iRxReminder
Enrollment
300
Locations
2
Primary Endpoint
AIMS Score
Status
Recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 30, 2023
End Date
December 31, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
iRxReminder
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • For the non-TD group:
  • Prescribed and taking an antipsychotic medication for 90-days or longer.
  • Tardive Dyskinesia symptoms if present are not from Parkinsons, Tourette's syndrome, Huntington disease.
  • Signed an informed consent.
  • Speaks English fluently.

Exclusion Criteria

  • Suffered a moderate or severe head injury in the last year;
  • History of a learning disorder or developmental disability that would inhibit a patient from completing the TD protocol.
  • Severe visual impairment that is cannot be corrected by glasses or contacts.

Outcomes

Primary Outcomes

AIMS Score

Time Frame: Baseline

Abnormal Involuntary Scale Score

Study Sites (2)

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