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Remote Monitoring and Detecting of Tardive Dyskinesia for Improving Patient Outcomes

Sponsor
iRxReminder (Industry)
Overall Status
Recruiting
CT.gov ID
NCT06011408
Collaborator
National Institute of Mental Health (NIMH) (NIH)
300
Enrollment
2
Locations
2
Arms
7.1
Anticipated Duration (Months)
150
Patients Per Site
21.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Other: TDtect
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
300 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Open-label, observational study with two groups taking antipsychotic with or without Tardive DyskinesiaOpen-label, observational study with two groups taking antipsychotic with or without Tardive Dyskinesia
Masking:
None (Open Label)
Primary Purpose:
Screening
Official Title:
Remote Monitoring and Detecting of Tardive Dyskinesia for Improving Patient Outcomes
Actual Study Start Date :
May 30, 2023
Anticipated Primary Completion Date :
Aug 30, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. AIMS Score [Baseline]

    Abnormal Involuntary Scale Score

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Fermata Helath Brooklyn New York United States 10038
2 Charak Research Center Garfield Heights Ohio United States 44125

Sponsors and Collaborators

  • iRxReminder
  • National Institute of Mental Health (NIMH)

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
iRxReminder
ClinicalTrials.gov Identifier:
NCT06011408
Other Study ID Numbers:
  • #23-002
  • R43MH114763
First Posted:
Aug 25, 2023
Last Update Posted:
Aug 25, 2023
Last Verified:
Aug 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Dyskinesias
Tardive Dyskinesia

Study Results

No Results Posted as of Aug 25, 2023