Objective Assessment of Behavioral Associations of Patients With Dementia

NCT02617056 | Completed

• 2 other identifiers: N1932-PRX001932-01
• Study Type: observational
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Dementia; Psychomotor Agitation

Keywords

electrodermal response

Outcome Measures

Primary Outcomes (1)

• Electrodermal activity

  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.

  Continuously over a period of 4-6 hours

Secondary Outcomes (1)

• Association of behaviors with electrodermal activity

  Continuously over a period of 4-6 hours

Study Arms (1)

Observational group

Subjects with dementia

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• any patient admitted to dementia unit at Bedford VAMC

You may not qualify if:

• inability to cooperate with electrodermal measurements

Sponsors & Collaborators

• VA Office of Research and Development: lead
• University of Massachusetts, Worcester: collaborator

Study Sites (1)

VA Bedford HealthCare System, Bedford, MA

Bedford, Massachusetts, 01730-1114, United States

Location

Related Publications (2)

• Greco FA, Deutsch CK. Carl Gustav Jung and the psychobiology of schizophrenia. Brain. 2017 Jan;140(1):e1. doi: 10.1093/brain/aww273. Epub 2016 Nov 15. No abstract available.

  PMID: 28031224 BACKGROUND

• Deutsch CK, Patnaik PP, Greco FA. Is There a Characteristic Autonomic Response During Outbursts of Combative Behavior in Dementia Patients? J Alzheimers Dis Rep. 2021 May 4;5(1):389-394. doi: 10.3233/ADR-210007.

  PMID: 34189410 RESULT

MeSH Terms

Conditions

Dementia; Psychomotor Agitation

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Dyskinesias; Neurologic Manifestations; Psychomotor Disorders; Neurobehavioral Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior

Study Officials

• Frank Greco, MD PhD

  VA Bedford HealthCare System, Bedford, MA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2015
• First Posted: November 30, 2015
• Study Start: January 1, 2016
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: March 4, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

US (1)