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The Assessment of Movement Disorders Utilizing Live Two-Way Video

This study is currently recruiting participants.
Verified January 2013 by North Shore Long Island Jewish Health System
Sponsor:
Information provided by (Responsible Party):
North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier:
NCT01467089
First received: October 31, 2011
Last updated: January 14, 2013
Last verified: January 2013
History of Changes
  Purpose

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


Condition Intervention
Tardive Dyskinesia
 Other: Two way video assessment

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: The Assessment of Movement Disorders Utilizing Live Two-Way Video

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by North Shore Long Island Jewish Health System:

Primary Outcome Measures:
  • Abnormal Involuntary Movement Scale (AIMS) when done in-person versus via two-way video [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Modified Simpson Angus Scale (mSAS) short version when done in-person versus via two-way video [ Time Frame: Baseline ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • the correlation between the short version and full version of the Modified Simpson Angus Scale (mSAS) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    total score of short version-Modified Simpson Angus Scale vs. total score of full version-Modified Simpson Angus Scale


Estimated Enrollment: 40
Study Start Date: November 2011
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
schizophrenia

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. Patients will be referred by their treating doctors if they have some evidence of movement disorder based on the physician's clinical judgment. We will also include 25% of the sample without any evidence of movement disorder.

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.

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

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

40 patients with schizophrenia will be recruited via in- and outpatient psychiatry service of The Zucker Hillside Hospital.

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01467089

Contacts
Contact: Taishiro Kishimoto, MD/PhD 718-470-8386 Tkishimoto@nshs.edu

Locations
United States, New York
The Zucker Hillside Hospital Recruiting
Glen Oaks, New York, United States, 11004
Contact: Taishiro Kishimoto, MD     718-470-8386     tkishimoto@nshs.edu    
Sponsors and Collaborators
North Shore Long Island Jewish Health System
Investigators
Principal Investigator: Tashiro Kishimoto, MD/PhD North Shore Long Island Jewish Health System
  More Information

No publications provided

Responsible Party: North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier: NCT01467089     History of Changes
Other Study ID Numbers: 11-243B
Study First Received: October 31, 2011
Last Updated: January 14, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by North Shore Long Island Jewish Health System:
Schizophrenia
Extrapyramidal symptoms
Tardive dyskinesia
Two Way Video Assessment

Additional relevant MeSH terms:
Dyskinesias
Movement Disorders
Central Nervous System Diseases
 Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on May 16, 2013