Remote Monitoring and Detecting of Tardive Dyskinesia for Improving Patient Outcomes
Primary Purpose
Tardive Dyskinesia
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
TDtect
Sponsored by
About this trial
This is an interventional screening trial for Tardive Dyskinesia
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.
Sites / Locations
- Fermata HelathRecruiting
- Charak Research CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Taking antipsychotic medication with Tardive Dyskinesia
Taking antipsychotic medication without Tardive Dyskinesia
Arm Description
Outcomes
Primary Outcome Measures
AIMS Score
Abnormal Involuntary Scale Score
Secondary Outcome Measures
Full Information
NCT ID
NCT06011408
First Posted
August 21, 2023
Last Updated
October 8, 2023
Sponsor
iRxReminder
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT06011408
Brief Title
Remote Monitoring and Detecting of Tardive Dyskinesia for Improving Patient Outcomes
Official Title
Remote Monitoring and Detecting of Tardive Dyskinesia for Improving Patient Outcomes
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 30, 2023 (Actual)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
iRxReminder
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tardive Dyskinesia
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Open-label, observational study with two groups taking antipsychotic with or without Tardive Dyskinesia
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Taking antipsychotic medication with Tardive Dyskinesia
Arm Type
Other
Arm Title
Taking antipsychotic medication without Tardive Dyskinesia
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
TDtect
Intervention Description
Collecting video data on abnormal movement
Primary Outcome Measure Information:
Title
AIMS Score
Description
Abnormal Involuntary Scale Score
Time Frame
Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anthony Sterns, Ph.D.
Phone
3306066675
Email
asterns@irxreminder.com
First Name & Middle Initial & Last Name or Official Title & Degree
Fred Ma, M.D., Ph.D.
Phone
2164695725
Email
fma@irxreminder.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rakesh Ranjan, M.D.
Organizational Affiliation
Charak Research Center
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Owen Muir, M.D.
Organizational Affiliation
Fermata Health
Official's Role
Study Director
Facility Information:
Facility Name
Fermata Helath
City
Brooklyn
State/Province
New York
ZIP/Postal Code
10038
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nogga Schwartz
Phone
917-634-4648
Email
nogga.schwartz@fermata.health
First Name & Middle Initial & Last Name & Degree
Owen Muir, M.D.
Facility Name
Charak Research Center
City
Garfield Heights
State/Province
Ohio
ZIP/Postal Code
44125
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kenzie Miller
Phone
216-280-6374
Email
kmiller@atcharakcenter.com
First Name & Middle Initial & Last Name & Degree
Rakesh Ranjan, M.D.
12. IPD Sharing Statement
Links:
URL
http://www.irxreminder.com
Description
Related Info
URL
http://www.charakcenter.com
Description
Related Info
URL
http://www.fermata.health
Description
Related Info
Learn more about this trial
Remote Monitoring and Detecting of Tardive Dyskinesia for Improving Patient Outcomes
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