Dementia Associated Apathy.

Skin Conductance and Heart Rate as Biomarkers to Uncover Covert Emotional Reactions in Patients With Dementia Associated Apathy; a Multi-centre Study.

We want to determine if patients with dementia show any kind of emotion while they look at a defined selection of photos. These are photos taken from a international image-platform and mixed with photos (biographic) that show personal objects, personal events, etc.

While the photos will be presented each a few seconds the skin conductance and the heart rate will be measured. We want to find out if there is any emotion measurable while showing the photos.

Study Overview

• Status: Unknown
• Conditions: Dementia; Emotions; Apathy
• Intervention / Treatment: Diagnostic test: Skin conductance and Heart rate measurement

Detailed Description

The lack of overt behaviour in individuals exhibiting dementia-associated apathy is not only stressful to family members and caregivers, it is also a major challenge for medical and nursing staff. Knowing whether apathy arises from an impaired function of the neural network of affect due to neurodegenerative processes accompanying dementia provides a neural explanation of this condition. Somatic indicators of affective responses (e.g., changes in skin conductance, or heart rate) are an effective means to uncover covert emotional responses in nursing home residents suffering from dementia associated apathy.

The overall objective is to determine whether dementia associated apathy is the result of an impaired functioning of the neural macro-network of affect. We want to compare the quantitative change in physiological parameters for each image category between individuals of the two subgroups: 1. Individual with dementia only and 2.individuals with dementia and dementia-associated apathy.

The primary objective is to uncover a covert emotional response using changes in skin conductance in patients with dementia and patients with dementia + dementia associated apathy.

The secondary objective is to uncover a covert emotional response using changes in the heart rate in patients with dementia and patients with dementia + dementia associated apathy.

Diagnosis of dementia, age at initial dementia diagnosis, age at initial apathy diagnosis, time since initial diagnosis of dementia and apathy will be obtained from medical records. The type and daily dose of medication as well as the type and frequency of occupational, physio- and psychosocial therapy will be drawn from medical records. The SMMSE (Severe Mini Mental State Examination)score will determine severity of dementia and the AES (Apathy Evaluation Scale )score the severity of apathy. Using the FAST (Functional Assessment Staging) will assess the capacity of performing the activities of daily life.

Measurements will be conducted in a familiar environment and in the presence of a family member or a member of staff to avoid any kind of stress and concern for the participant. The subject will be informed of the procedure and their task before the sensors are attached. Electrodermal activity (EDA) and heart rate (HR) will be continuously monitored while the subject views the image sequence on a PC monitor. EDA and HR will be recorded concurrently using commercial software. Data analysis will involve both commercial and in-house software. All data will be stored on a hard disk, in a compressed and encrypted format.

• Study Type: Interventional
• Enrollment (Anticipated): 133
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Thurgau
    • Winterthur, Thurgau, Switzerland
      • Recruiting
      • Zurich University of Applied Sciences
      • Contact: Silke Neumann, MSc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• existing medical diagnosis of dementia, independent of the presence or absence of neuropsychiatric symptoms.

We include nursing home residents with Informed Consent as documented by signature from the German speaking part of Switzerland with moderate to severe dementia.

The presence or absence of apathy serves to assign participants into the appropriate experiments group.

Exclusion Criteria:

• Known or suspected non-compliance, drug or alcohol abuse,

  • Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders
  • Previous enrolment into the current study,
  • Enrolment of the investigator, his/her family members, employees and other dependent persons,
  • Medically documented diagnosis of schizophrenia or bipolar disorder or the diagnosis of diminished intelligence.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Patients with dementia; The subject will be informed of the procedure and their task before the sensors are attached. Electrodermal activity (EDA) and heart rate (HR) will be continuously monitored while the subject views the image sequence on a PC monitor. EDA will be measured using electrodes attached to the middle (D3) and ring finger (D4). Heart rate will be measured using an infrared pulseoximeter attached to one of the free digits of the hand. A pulseoximeter is a non-invasive sensor, using tissue absorption of infrared light to determine blood-oxygen saturation (SaO2). EDA and HR will be recorded concurrently using commercial software. Data analysis will involve both commercial and in-house software.

Diagnostic test: Skin conductance and Heart rate measurement; while observing selected photos the Skin conductance and heart rate will be measured.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Skin conductance	The change in skin conductance will be taken to be the peak amplitude of the change in skin conductance	15 minutes
Heart rate	The heart rate measured in Hertz (HZ). The Heart rate will be measured using an infrared pulseoximeter attached to one of the free digits of the hand.	15minutes

Collaborators and Investigators

• Sponsor: Zurich University of Applied Sciences
• Investigators: Study Chair: Heidrun Becker, Prof.DR., Zurich University of Applied Sciences

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2017
• Primary Completion (Anticipated): December 31, 2018
• Study Completion (Anticipated): July 31, 2019

Study Registration Dates

• First Submitted: September 21, 2017
• First Submitted That Met QC Criteria: September 21, 2017
• First Posted (Actual): September 26, 2017

Study Record Updates

• Last Update Posted (Actual): July 16, 2018
• Last Update Submitted That Met QC Criteria: July 12, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: Emotion; Dementia; Heart rate; Images; Skin conductance; Aphathy
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Dementia
• Other Study ID Numbers: Biomarker and Apathy

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No