DementiaNCT02617056
Objective Assessment of Behavioral Associations of Patients With Dementia
An observational study of Dementia and Psychomotor Agitation, run by VA Office of Research and Development at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Dementia, Psychomotor Agitation
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2016to 30 Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: patients in dementia unit have advanced dementia; a small number of young adult controls will be studied to validate electrodermal measurements
Who may be able to join
- any patient admitted to dementia unit at Bedford VAMC
Who cannot join
- inability to cooperate with electrodermal measurements
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Bedford HealthCare System, Bedford, MA
Bedford, Massachusetts, 01730-1114
About this study
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.
Read the detailed description
- Objective(s): The key goal of this project is to develop methods for objectively monitoring and, ultimately, predicting outbursts of aberrant behaviors commonly seen among patients with a variety of neuropsychiatric conditions: dementia, PTSD, TBI, and schizophrenia. This initial study will be on patients with dementia. The analytic focus is on the measurement of electrodermal activity (EDA), a widely-studied physiological recording that indicates sympathetic tone; the central hypothesis in this approach is that sympathetic tone will increase prior to an outburst and, therefore, may allow therapeutic interventions to prevent it. Alterations of sympathetic activity have been implicated in the literature for each of these four conditions. Here, EDA recording holds the advantages of requiring neither effort nor communication on the part of the subject, and of being a noninvasive procedure. These factors make EDA potentially useful for the clinical assessment of arousal among patients with dementia, which will be the first of the specific groups studied under this protocol.
- Research Design: The general design of all of these studies is the monitoring of EDA in subjects with a small device that can be worn on the wrist, ankle or arm; patterns of spontaneous EDA will then be assessed for features that may predict the occurrence of an outburst. In the initial study of dementia patients, the investigators will first survey EDA responses in commonly used paradigms (e.g., visual stimulus, EDA response). Currently, little is known about EDA in this population, and the investigators redress this by (1) establishing behavioral and physiological baselines for each subject in the study, (2) determining how these two classes of dependent measures cohere, and (3) evaluating whether patterns of EDA differ as a function of aberrant behaviors that are often seen in dementia: wandering, combativeness, and "sundowning" (agitation that typically develops late in the day). These behaviors are often grouped in the literature under the term "disorders of arousal", and are clinically well known to present as signs of disorientation and in some cases, distress. (4) Moreover, quantitative assessment of EDA change conceivably may reveal patterns that may signal the onset of problem behaviors. Each subject will serve as his/her own control, providing within-subject measures of EDA signal over time and its correlation with aberrant behaviors. It is worth noting that the key EDA measures are not subject to bias based on experimenter ratings. Further, the aberrant behaviors will also be rated over time, using quantitative rating scales for each of them. In a second class of analyses, the investigators will perform group contrasts of subjects with and without these aberrant behaviors, as operationally defined by rating scales, to determine if patients with these problem behaviors are distinctive as a group with respect to EDA patterns. All statistical analysis will be performed on anonymized data, blind to group membership.
- Methodology: EDA will be measured by standard techniques in all subjects: electrodes may be placed on the hands, feet, ankles, wrists, or arm according to preference and configured to measure conductivity or potential. In one portion of the study, a wearable device to measure EDA will be used to determine whether EDA predicts the occurrence of an outburst. In the study with dementia patients, assessments will be performed at an inpatient dementia care facility at the Bedford VAMC (GRECC). Over a two-year period, the investigators anticipate enrolling 60 subjects. Recruitment criteria include toleration of the EDA recording device worn on the wrist (similar to a watch) or the ankle. Skin potential, skin conductance, and membrane electrical power will be monitored and data recorded electronically. Data will be de-identified by assigning the serial subject number to each patient; a table linking the number to the subject's identity will be kept on a secure VA server, allowing re-identification after data analysis.
- Findings: If successful, EDA may predict an outburst of aberrant behavior with enough lead time to permit a preventive intervention.
- Clinical Relationships: The investigators hypothesize that: (a) stable physiologic baselines can be obtained for EDA measures, (b) EDA signals are altered as a function of aberrant behaviors ("disorders of arousal") on a within-subject basis, and (c) group differences will emerge between samples of patients with and without these aberrant behaviors.
- Impact/Significance: If the EDA were borne out as a sensitive measure of disorders of arousal, this measure may find application in the assessment and treatment of dementia.
- Conditions
- Dementia, Psychomotor Agitation
- Keywords
- electrodermal response
- Medical subject headings
- Dementia, Psychomotor Agitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Observational group | Subjects with dementia |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Continuously over a period of 4-6 hours
Secondary outcomes (1)
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.
Measured: Continuously over a period of 4-6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2015 (estimated)
- Study start1 Jan 2016
- Primary completion30 Sep 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- University of Massachusetts, Worcester
- Responsible party
- Sponsor
- Investigators
- Frank Greco, MD PhD, Principal investigator, VA Bedford HealthCare System, Bedford, MA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02617056
- Sponsor's protocol ID
- N1932-P
- Other IDs
- RX001932-01
- Status last verified
- Mar 2026
- First submitted
- 25 Nov 2015
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Upon request after publication.
Publications
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.
PubMed 28031224Deutsch 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.
PubMed 34189410
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Objective Assessment of Behavioral Associations of Patients With Dementia
- ClinicalTrials.gov ID
- NCT02617056
- Acronym / sponsor ID
- N1932-P
- Conditions
- Dementia, Psychomotor Agitation
- Keywords
- electrodermal response
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- University of Massachusetts, Worcester
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 30 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- Objective(s): The key goal of this project is to develop methods for objectively monitoring and, ultimately, predicting outbursts of aberrant behaviors commonly seen among patients with a variety of neuropsychiatric conditions: dementia, PTSD, TBI, and schizophrenia. This initial study will be on patients with dementia. The analytic focus is on the measurement of electrodermal activity (EDA), a widely-studied physiological recording that indicates sympathetic tone; the central hypothesis in this approach is that sympathetic tone will increase prior to an outburst and, therefore, may allow therapeutic interventions to prevent it. Alterations of sympathetic activity have been implicated in the literature for each of these four conditions. Here, EDA recording holds the advantages of requiring neither effort nor communication on the part of the subject, and of being a noninvasive procedure. These factors make EDA potentially useful for the clinical assessment of arousal among patients with dementia, which will be the first of the specific groups studied under this protocol.
- Research Design: The general design of all of these studies is the monitoring of EDA in subjects with a small device that can be worn on the wrist, ankle or arm; patterns of spontaneous EDA will then be assessed for features that may predict the occurrence of an outburst. In the initial study of dementia patients, the investigators will first survey EDA responses in commonly used paradigms (e.g., visual stimulus, EDA response). Currently, little is known about EDA in this population, and the investigators redress this by (1) establishing behavioral and physiological baselines for each subject in the study, (2) determining how these two classes of dependent measures cohere, and (3) evaluating whether patterns of EDA differ as a function of aberrant behaviors that are often seen in dementia: wandering, combativeness, and "sundowning" (agitation that typically develops late in the day). These behaviors are often grouped in the literature under the term "disorders of arousal", and are clinically well known to present as signs of disorientation and in some cases, distress. (4) Moreover, quantitative assessment of EDA change conceivably may reveal patterns that may signal the onset of problem behaviors. Each subject will serve as his/her own control, providing within-subject measures of EDA signal over time and its correlation with aberrant behaviors. It is worth noting that the key EDA measures are not subject to bias based on experimenter ratings. Further, the aberrant behaviors will also be rated over time, using quantitative rating scales for each of them. In a second class of analyses, the investigators will perform group contrasts of subjects with and without these aberrant behaviors, as operationally defined by rating scales, to determine if patients with these problem behaviors are distinctive as a group with respect to EDA patterns. All statistical analysis will be performed on anonymized data, blind to group membership.
- Methodology: EDA will be measured by standard techniques in all subjects: electrodes may be placed on the hands, feet, ankles, wrists, or arm according to preference and configured to measure conductivity or potential. In one portion of the study, a wearable device to measure EDA will be used to determine whether EDA predicts the occurrence of an outburst. In the study with dementia patients, assessments will be performed at an inpatient dementia care facility at the Bedford VAMC (GRECC). Over a two-year period, the investigators anticipate enrolling 60 subjects. Recruitment criteria include toleration of the EDA recording device worn on the wrist (similar to a watch) or the ankle. Skin potential, skin conductance, and membrane electrical power will be monitored and data recorded electronically. Data will be de-identified by assigning the serial subject number to each patient; a table linking the number to the subject's identity will be kept on a secure VA server, allowing re-identification after data analysis.
- Findings: If successful, EDA may predict an outburst of aberrant behavior with enough lead time to permit a preventive intervention.
- Clinical Relationships: The investigators hypothesize that: (a) stable physiologic baselines can be obtained for EDA measures, (b) EDA signals are altered as a function of aberrant behaviors ("disorders of arousal") on a within-subject basis, and (c) group differences will emerge between samples of patients with and without these aberrant behaviors.
- Impact/Significance: If the EDA were borne out as a sensitive measure of disorders of arousal, this measure may find application in the assessment and treatment of dementia.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational group | – | –Subjects with dementia |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients in dementia unit have advanced dementia; a small number of young adult controls will be studied to validate electrodermal measurements
Key inclusion criteria (1 listed)
- any patient admitted to dementia unit at Bedford VAMC
Key exclusion criteria (1 listed)
- inability to cooperate with electrodermal measurements
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Association of behaviors with electrodermal activity
Time frame: Continuously over a period of 4-6 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2026.
- Background: PubMed 28031224Greco 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.
- Results publication: PubMed 34189410Deutsch 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.
- Individual participant dataSharing planned: Yes. Upon request after publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frank Greco, MD PhD principal investigator
VA Bedford HealthCare System, Bedford, MA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dementia and Psychomotor Agitation, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Electrodermal activity (time frame: Continuously over a period of 4-6 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02617056, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2026; AzTrials last refreshed its copy on 8 Nov 2026.