Dementia Clinical Trial
Official title:
Objective Assessment of Behavioral Associations of Patients With Dementia
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.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | December 31, 2025 |
Est. primary completion date | December 31, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - any patient admitted to dementia unit at Bedford VAMC Exclusion Criteria: - inability to cooperate with electrodermal measurements |
Country | Name | City | State |
---|---|---|---|
United States | VA Bedford HealthCare System, Bedford, MA | Bedford | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
VA Office of Research and Development | University of Massachusetts, Worcester |
United States,
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Association of behaviors with electrodermal activity | 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. | Continuously over a period of 4-6 hours |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05686486 -
Gentle Gymnastics and Relationship Between Family Caregivers and Residents With Dementia in Nursing Homes
|
N/A | |
Terminated |
NCT05451693 -
Outreach-ER: A Dementia Care Intervention Program
|
||
Recruiting |
NCT05820919 -
Enhancing Sleep Quality for Nursing Home Residents With Dementia - R33 Phase
|
N/A | |
Enrolling by invitation |
NCT06040294 -
Dementia and Disability Simulation for College Nursing Students' Senior Activity Facilitation Skills
|
N/A | |
Completed |
NCT05114187 -
An Internet-Based Education Program for Care Partners of People Living With Dementia
|
N/A | |
Recruiting |
NCT06322121 -
Vascular Aspects in Dementia: Part 2
|
||
Active, not recruiting |
NCT03676881 -
Longitudinal Validation of a Computerized Cognitive Battery (Cognigram) in the Diagnosis of Mild Cognitive Impairment and Alzheimer's Disease
|
||
Completed |
NCT04426838 -
Cognitive Behavioral Therapy for Insomnia for the Dementia Caregiving Dyad
|
N/A | |
Recruiting |
NCT03462485 -
Pilot Study of the Effects of Playing Golf on People With Dementia
|
N/A | |
Active, not recruiting |
NCT03677284 -
Managing Time With Dementia: Effects of Time Assistive Products in People With Dementia
|
N/A | |
Completed |
NCT03849937 -
Changing Talk Online (CHATO) Study
|
N/A | |
Recruiting |
NCT06284213 -
Biomarkers for Vascular Contributions to Cognitive Impairment and Dementia Consortium
|
||
Recruiting |
NCT05579236 -
Cortical Disarray Measurement in Mild Cognitive Impairment and Alzheimer's Disease
|
||
Completed |
NCT05080777 -
Pilot Pragmatic Clinical Trial to Embed Tele-Savvy Into Health Care Systems
|
N/A | |
Completed |
NCT04571697 -
A Study of Comparing Rates of Dementia and Alzheimer's Disease in Participants Initiating Methotrexate Versus Those Initiating Anti-tumor Necrosis Factor (TNF)-Alpha Therapy
|
||
Completed |
NCT03583879 -
Using Gait Robotics to Improve Symptoms of Parkinson's Disease
|
N/A | |
Recruiting |
NCT06033066 -
Financial Incentives and Recruitment to the APT Webstudy
|
N/A | |
Active, not recruiting |
NCT05204940 -
Longitudinal Observational Biomarker Study
|
||
Recruiting |
NCT05684783 -
Dementia Champions in Homecare
|
||
Completed |
NCT03147222 -
Function Focused Care: Fracture Care at Home
|
N/A |