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Dementia Associated Apathy.

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03293537
Recruitment Status : Unknown
Verified July 2018 by Silke Neumann, Zurich University of Applied Sciences.
Recruitment status was:  Recruiting
First Posted : September 26, 2017
Last Update Posted : July 16, 2018
Sponsor:
Information provided by (Responsible Party):
Silke Neumann, Zurich University of Applied Sciences

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Emotions Dementia Apathy Diagnostic Test: Skin conductance and Heart rate measurement Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 133 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Skin Conductance and Heart Rate as Biomarkers to Uncover Covert Emotional Reactions in Patients With Dementia Associated Apathy; a Multi-centre Study.
Actual Study Start Date : October 30, 2017
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : July 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dementia

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.




Primary Outcome Measures :
  1. Skin conductance [ Time Frame: 15 minutes ]
    The change in skin conductance will be taken to be the peak amplitude of the change in skin conductance

  2. Heart rate [ Time Frame: 15minutes ]
    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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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 ClinicalTrials.gov identifier (NCT number): NCT03293537


Contacts
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Contact: Silke Neumann, MSc 0041 58 934 49 76 neus@zhaw.ch

Locations
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Switzerland
Zurich University of applied Sciences Recruiting
Winterthur, Thurgau, Switzerland
Contact: Silke Neumann, MSc         
Sponsors and Collaborators
Zurich University of Applied Sciences
Investigators
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Study Chair: Heidrun Becker, Prof.DR. Zurich University of Applied Sciences
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Responsible Party: Silke Neumann, MSc, Zurich University of Applied Sciences
ClinicalTrials.gov Identifier: NCT03293537    
Other Study ID Numbers: Biomarker and Apathy
First Posted: September 26, 2017    Key Record Dates
Last Update Posted: July 16, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Silke Neumann, Zurich University of Applied Sciences:
Dementia
Aphathy
Emotion
Images
Skin conductance
Heart rate
Additional relevant MeSH terms:
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Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders