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RecruitingNCT06011408Updated Mar 12, 2024

Remote Monitoring and Detecting of Tardive Dyskinesia for Improving Patient Outcomes

An interventional study of TDtect in Tardive Dyskinesia, sponsored by iRxReminder. Recruiting at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-12.

Sponsored by iRxReminder · Not applicable, Interventional, and Screening

From the registry’s dates

  • Primary completion was expected by Nov 2024, 1 year 10 months ago, but the record still lists the study as recruiting.
  • Started May 2023; still recruiting 3 years 4 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
300
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Tardive Dyskinesia
03

In context

Dyskinesias

270 studies on the registry are indexed under Dyskinesias; 41 are open to participants now.

This study's planned enrollment of 300 is above the median of 44 across 192 interventional studies indexed under Dyskinesias.

Browse Dyskinesias studies →

Lead sponsor

This is the only study on the registry with iRxReminder as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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.
05

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
300 participants (estimated)

Study arms

  • Other
    Taking antipsychotic medication with Tardive Dyskinesia

    Other: TDtect

  • Other
    Taking antipsychotic medication without Tardive Dyskinesia

    Other: TDtect

Interventions

  • OtherTDtect

    Collecting video data on abnormal movement

06

What researchers measure

Primary outcomes

  1. AIMS Score

    Abnormal Involuntary Scale Score

    Time frame: Baseline

07

Study locations

2 of 2 sites recruiting
  • Fermata Helath
    Brooklyn, New York 10038, United States
    Recruiting
  • Charak Research Center
    Garfield Heights, Ohio 44125, United States
    Recruiting
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 12, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06011408
Lead sponsor
iRxReminder
Collaborators
National Institute of Mental Health (NIMH)
Responsible party
Sponsor
First posted
Aug 25, 2023
Start date
May 30, 2023
Primary completion
Nov 30, 2024 (estimated)
Completion
Dec 31, 2024 (estimated)
Last update
Mar 12, 2024

Study contacts

Anthony Sterns, Ph.D.
Contact
asterns@irxreminder.com
3306066675
Fred Ma, M.D., Ph.D.
Contact
fma@irxreminder.com
2164695725
Rakesh Ranjan, M.D.
study director · Charak Research Center
Owen Muir, M.D.
study director · Fermata Health

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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