The Assessment of Movement Disorders Utilizing Live Two-Way Video

Tardive Dyskinesia Clinical Trial

Official title:

The Assessment of Movement Disorders Utilizing Live Two-Way Video

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01467089
• Other study ID #: 11-243B
• Status: Completed
• Phase: N/A
• First received: October 31, 2011
• Last updated: September 19, 2016
• Start date: November 2011
• Est. completion date: June 2016

Study information

• Verified date: September 2016
• Source: Northwell Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

The purpose of this project is to determine the equivalency of extrapyramidal symptoms (EPS) and tardive dyskinesia (TD) examinations conducted via live two-way video versus live examinations completed in-person

Description:

Extrapyramidal symptoms (EPS) and tardive dyskinesia (TD) are one of the most frequent and troublesome adverse events when taking antipsychotic agents. The investigators aim in this study to determine if the investigators can conduct examinations for EPS and TD remotely using live two-way video. It is potentially beneficial for patients, especially those who are located far away from psychiatrists if they could be seen by trained clinicians and assessed for EPS and TD via two-way video in the future. Participants will be asked to have a medical assessment which consists of simple questions and some examination of their movements via two-way video and in person. The investigators will compare the results of video examinations with the results of live examinations.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Inpatients and outpatients aged 18-75 years old who have been taking antipsychotics for longer than 6 months in their life time, and

• That have been compliant for the past week.

Exclusion Criteria:

• Patients who have medical conditions which make it difficult to perform a physical examination.

• Patients who are clinically too ill to consent and/or unable to cooperate with the examination procedures.

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Dyskinesias
• Movement Disorders
• Tardive Dyskinesia

Intervention

Other:
• Two way video assessment
Participants will be assessed extrapyramidal symptoms and tardive dyskinesia

Locations

Country	Name	City	State
United States	The Zucker Hillside Hospital	Glen Oaks	New York

Sponsors (1)

Lead Sponsor	Collaborator
Northwell Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Abnormal Involuntary Movement Scale (AIMS) when done in-person versus via two-way video		Baseline	No
Primary	Modified Simpson Angus Scale (mSAS) short version when done in-person versus via two-way video		Baseline	No
Secondary	the correlation between the short version and full version of the Modified Simpson Angus Scale (mSAS)	total score of short version-Modified Simpson Angus Scale vs. total score of full version-Modified Simpson Angus Scale	Baseline	No