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Objective Assessment of Behavioral Associations of Patients With Dementia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02617056
Recruitment Status : Recruiting
First Posted : November 30, 2015
Last Update Posted : May 16, 2019
University of Massachusetts, Worcester
Information provided by (Responsible Party):
VA Office of Research and Development

Brief Summary:
It is generally acknowledged that patients with dementia are best cared for at home. However, outbursts of various behavioral disturbances, e.g., combativeness, appear in most cases and often necessitate institutionalization. These outbursts are often without apparent warning, which limits preventive interventions. The measurement of the electrical activity of the skin is well-studied as an indicator of stress or agitation. The investigators propose to monitor the electrical activity of skin in patients with dementia in order to determine whether any sign of agitation may occur before the outburst. If skin electrical activity gives sufficient warning, then preventive interventions may be tried. If successful, the ability to predict and prevent outbursts of behavioral disturbances will allow patients to be cared for at home for longer periods. It is the primary aim of this project to determine whether skin electrical activity gives such a warning; possible preventive measures will be the subject of future studies.

Condition or disease
Dementia Psychomotor Agitation

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: Objective Assessment of Behavioral Associations of Patients With Dementia
Actual Study Start Date : January 1, 2016
Estimated Primary Completion Date : December 29, 2019
Estimated Study Completion Date : December 29, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dementia

Observational group
Subjects with dementia

Primary Outcome Measures :
  1. Electrodermal activity [ Time Frame: Continuously over a period of 4-6 hours ]
    The purpose of this trial is to determine whether a signal of electrodermal activity (EDA) will precede an outburst of a behavioral disturbance by enough time to permit an intervention to prevent that behavior. This is a pilot project to test this hypothesis; subsequent studies will test the effectiveness of interventions. Therefore, the primary outcome sought is the detection of such a signal. EDA includes skin potential and skin conductivity. The time course of these two measurements form electrical signals. The shape of these signals will be characterized by mean value, spectral analysis and principle component analysis. The three analyses of two signals lead to six categories of information about the subject that will be examined as predictors of an outburst. Each subject will serve as his own control. More specifically, a successful outcome of this pilot project is that information from these six categories, alone or in combination, can predict an outburst.

Secondary Outcome Measures :
  1. Association of behaviors with electrodermal activity [ Time Frame: Continuously over a period of 4-6 hours ]
    While observing a subject to detect a signal for measure 1 above, we expect to detect minor variations of electrodermal activity that may correlate with objects in the environment, indicating a stress response that may not be apparent from the subject's demeanor. This may reveal unsuspected stress factors in the environment, the reduction of which may improve the subject's well being.

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
patients in dementia unit have advanced dementia; a small number of young adult controls will be studied to validate electrodermal measurements

Inclusion Criteria:

  • any patient admitted to dementia unit at Bedford VAMC

Exclusion Criteria:

  • inability to cooperate with electrodermal measurements

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 identifier (NCT number): NCT02617056

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Contact: Frank Greco, MD PhD (781) 687-3265

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United States, Massachusetts
Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA Recruiting
Bedford, Massachusetts, United States, 01730
Contact: Joseph Squicciarini    781-687-2926   
Contact: John M Wells, PhD    (781) 687-2924   
Principal Investigator: Frank Greco, MD PhD         
Sponsors and Collaborators
VA Office of Research and Development
University of Massachusetts, Worcester
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Principal Investigator: Frank Greco, MD PhD Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA

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Responsible Party: VA Office of Research and Development Identifier: NCT02617056     History of Changes
Other Study ID Numbers: N1932-P
RX001932-01 ( Other Grant/Funding Number: VA RR&D )
First Posted: November 30, 2015    Key Record Dates
Last Update Posted: May 16, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Upon request after publication.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by VA Office of Research and Development:
electrodermal response

Additional relevant MeSH terms:
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Psychomotor Agitation
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Neurologic Manifestations
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms