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The Assessment of Movement Disorders Utilizing Live Two-Way Video

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ClinicalTrials.gov Identifier: NCT01467089
Recruitment Status : Completed
First Posted : November 8, 2011
Last Update Posted : September 21, 2016
Sponsor:
Information provided by (Responsible Party):
Sandeep kapoor, Northwell Health

Brief 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

Condition or disease Intervention/treatment
Tardive Dyskinesia Other: Two way video assessment

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.

Study Type : Observational
Actual Enrollment : 37 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: The Assessment of Movement Disorders Utilizing Live Two-Way Video
Study Start Date : November 2011
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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




Primary Outcome Measures :
  1. Abnormal Involuntary Movement Scale (AIMS) when done in-person versus via two-way video [ Time Frame: Baseline ]
  2. Modified Simpson Angus Scale (mSAS) short version when done in-person versus via two-way video [ Time Frame: Baseline ]

Secondary Outcome Measures :
  1. the correlation between the short version and full version of the Modified Simpson Angus Scale (mSAS) [ Time Frame: Baseline ]
    total score of short version-Modified Simpson Angus Scale vs. total score of full version-Modified Simpson Angus Scale



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01467089


Locations
United States, New York
The Zucker Hillside Hospital
Glen Oaks, New York, United States, 11004
Sponsors and Collaborators
Northwell Health
Investigators
Principal Investigator: Sandeep Kapoor, MD Northwell Health

Responsible Party: Sandeep kapoor, Principal Investigator, Northwell Health
ClinicalTrials.gov Identifier: NCT01467089     History of Changes
Other Study ID Numbers: 11-243B
First Posted: November 8, 2011    Key Record Dates
Last Update Posted: September 21, 2016
Last Verified: September 2016

Keywords provided by Sandeep kapoor, Northwell Health:
Schizophrenia
Extrapyramidal symptoms
Tardive dyskinesia
Two Way Video Assessment

Additional relevant MeSH terms:
Dyskinesias
Movement Disorders
Tardive Dyskinesia
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Dyskinesia, Drug-Induced