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Arousal Response Tool for Neurological Disease (ART_ND)

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ClinicalTrials.gov Identifier: NCT03425877
Recruitment Status : Recruiting
First Posted : February 8, 2018
Last Update Posted : February 8, 2018
Sponsor:
Collaborators:
Università Politecnica delle Marche
University of Padua
Information provided by (Responsible Party):
Patrizio Sale, IRCCS San Camillo, Venezia, Italy

Brief Summary:
The present study therefore aims at studying and evaluating the state of activation by psycho-physiological, behavioral, and subjective responses of individuals with Stroke and Parkinson's disease in contexts from the gradual increase in cognitive and stress loads, in order to provide information on the possibility Use of biofeedback devices in rehabilitation contexts.Objectives: assess the psychophysical response; to describe the configuration of physiological activation patterns; to determine the interaction effect between task type and pathology; to assess behavioral response;to describe the performance; to determine the interaction effect between task type and pathology; to evaluate the subjective response; to measure the degree of awareness of your state and your performance.

Condition or disease Intervention/treatment Phase
Parkinson Disease Stroke Healthy Device: MS Band 2 Behavioral: Emotion Assessment Behavioral: Single Task Behavioral: Dual Task Behavioral: Rest Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Arousal Response Tool for Neurological Disease
Actual Study Start Date : April 22, 2017
Estimated Primary Completion Date : April 30, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Parkinson's disease Group

The study envisages the recruitment of 45 subjects (see Sample Size on page 11), to be divided into 15 subjects per group. The groups will be formed by subjects diagnosed with Parkinson's and Stroke disease, for 50% men and 50% for women. The control subjects, on the other hand, will be neurologically healthy volunteers of equal age and scholarship and gender.

All the groups will attend the same procedure and interventions: MS Band 2 , Rest, Emotion Assessment, Single Task, Dual Task .

Device: MS Band 2
Before starting the experiments, the subjects will be helped to wear the Microsoft® Band 2 bracelet (a smartwatch capable of recording data from over 12 sensors, including a heart rate sensor and a skin conductance sensor) and a session will be recorded Of 10 minutes at rest. After the rest period and always wearing the Microsoft® Band 2, the subjects will perform the other session of the procedure.
Other Name: Wristband (GSR, HR)

Behavioral: Emotion Assessment
The subjects will be subjected to the viewing of 21 video clips depicting 6 different emotional states belonging to the FilmStim database validated by Schaefer's studio and collaborators (Schaefer, Nils, Sanchez, & Philippot, 2010). When viewing the clip, subjects will wear the Microsoft ® Band 2 .and after each movie clip of an evaluation of the stimulus value and activation level perceived by the Self-Assessment Manikin (Bradley & Lang, 1994) questionnaire). The presentation of movie clip is randomized and does not follow a fixed effect. Between the presentation of each clip a fixed interval of 15 seconds has been inserted in order to induce artifacts and overlap of physiological signals among different emotional valence video clips.
Other Name: Arousal report, behavioural, cognitive performance

Behavioral: Single Task
The section includes three tasks which involve upper and lower extremities, and cognitive functions, associated with low cognitive and motor load for their execution. Subjects are required to perform a single task, i.e. without the simultaneous execution of other tasks. Grasping(Motor Upper Limbs): The subject is required to reach an object's dominant limb and grab it. Walking(Motor Lower Limbs): It is required to carry 10 feet of walk. Attention(Cognitive): Signal detection task. The subject is required to detect acute sound between a series of serious sounds (Oddball Paradigm).

Behavioral: Dual Task
This section includes three tasks of different types (upper limb motor, lower limb motor, cognitive) that will be performed with a greater cognitive load. Elbow N-back (Dual Task Motor upper limbs): The subject is required to reconfigure the arrangement of the floppy disks on a different blade, by moving only one disk at a time and by putting a disk on another bigger disk, never on a smaller one. Walking + Nback (Dual Task Motor lower limbs): The subject is required to walk while subtracting from 100 to 3 in 3. Problem Solving (Dual Task Cognitive): The subject is subjected to a deductive logic puzzle.

Behavioral: Rest
At this stage, the HR and GSR signals will be recorded during a period of rest of 10 minutes. The subjects wear a pair of headphone for reducing the environmental sound noise. Through the headphones a sound indicates to the subject when recording starts and stops. Two separate recording of 5 minutes are performed, the first is performed while keeping eyes closed The two session are presented randomly to each different subject in order to prevent a bias due to order effect .

Experimental: Stroke Group

The study envisages the recruitment of 45 subjects (see Sample Size on page 11), to be divided into 15 subjects per group. The groups will be formed by subjects diagnosed with Parkinson's and Stroke disease, for 50% men and 50% for women. The control subjects, on the other hand, will be neurologically healthy volunteers of equal age and scholarship and gender.

All the groups will attend the same procedure and interventions: MS Band 2 , Rest, Emotion Assessment, Single Task, Dual Task .

Device: MS Band 2
Before starting the experiments, the subjects will be helped to wear the Microsoft® Band 2 bracelet (a smartwatch capable of recording data from over 12 sensors, including a heart rate sensor and a skin conductance sensor) and a session will be recorded Of 10 minutes at rest. After the rest period and always wearing the Microsoft® Band 2, the subjects will perform the other session of the procedure.
Other Name: Wristband (GSR, HR)

Behavioral: Emotion Assessment
The subjects will be subjected to the viewing of 21 video clips depicting 6 different emotional states belonging to the FilmStim database validated by Schaefer's studio and collaborators (Schaefer, Nils, Sanchez, & Philippot, 2010). When viewing the clip, subjects will wear the Microsoft ® Band 2 .and after each movie clip of an evaluation of the stimulus value and activation level perceived by the Self-Assessment Manikin (Bradley & Lang, 1994) questionnaire). The presentation of movie clip is randomized and does not follow a fixed effect. Between the presentation of each clip a fixed interval of 15 seconds has been inserted in order to induce artifacts and overlap of physiological signals among different emotional valence video clips.
Other Name: Arousal report, behavioural, cognitive performance

Behavioral: Single Task
The section includes three tasks which involve upper and lower extremities, and cognitive functions, associated with low cognitive and motor load for their execution. Subjects are required to perform a single task, i.e. without the simultaneous execution of other tasks. Grasping(Motor Upper Limbs): The subject is required to reach an object's dominant limb and grab it. Walking(Motor Lower Limbs): It is required to carry 10 feet of walk. Attention(Cognitive): Signal detection task. The subject is required to detect acute sound between a series of serious sounds (Oddball Paradigm).

Behavioral: Dual Task
This section includes three tasks of different types (upper limb motor, lower limb motor, cognitive) that will be performed with a greater cognitive load. Elbow N-back (Dual Task Motor upper limbs): The subject is required to reconfigure the arrangement of the floppy disks on a different blade, by moving only one disk at a time and by putting a disk on another bigger disk, never on a smaller one. Walking + Nback (Dual Task Motor lower limbs): The subject is required to walk while subtracting from 100 to 3 in 3. Problem Solving (Dual Task Cognitive): The subject is subjected to a deductive logic puzzle.

Behavioral: Rest
At this stage, the HR and GSR signals will be recorded during a period of rest of 10 minutes. The subjects wear a pair of headphone for reducing the environmental sound noise. Through the headphones a sound indicates to the subject when recording starts and stops. Two separate recording of 5 minutes are performed, the first is performed while keeping eyes closed The two session are presented randomly to each different subject in order to prevent a bias due to order effect .

Experimental: Healthy Subjects Group

The study envisages the recruitment of 45 subjects (see Sample Size on page 11), to be divided into 15 subjects per group. The groups will be formed by subjects diagnosed with Parkinson's and Stroke disease, for 50% men and 50% for women. The control subjects, on the other hand, will be neurologically healthy volunteers of equal age and scholarship and gender.

All the groups will attend the same procedure and interventions: MS Band 2 , Rest, Emotion Assessment, Single Task, Dual Task .

Device: MS Band 2
Before starting the experiments, the subjects will be helped to wear the Microsoft® Band 2 bracelet (a smartwatch capable of recording data from over 12 sensors, including a heart rate sensor and a skin conductance sensor) and a session will be recorded Of 10 minutes at rest. After the rest period and always wearing the Microsoft® Band 2, the subjects will perform the other session of the procedure.
Other Name: Wristband (GSR, HR)

Behavioral: Emotion Assessment
The subjects will be subjected to the viewing of 21 video clips depicting 6 different emotional states belonging to the FilmStim database validated by Schaefer's studio and collaborators (Schaefer, Nils, Sanchez, & Philippot, 2010). When viewing the clip, subjects will wear the Microsoft ® Band 2 .and after each movie clip of an evaluation of the stimulus value and activation level perceived by the Self-Assessment Manikin (Bradley & Lang, 1994) questionnaire). The presentation of movie clip is randomized and does not follow a fixed effect. Between the presentation of each clip a fixed interval of 15 seconds has been inserted in order to induce artifacts and overlap of physiological signals among different emotional valence video clips.
Other Name: Arousal report, behavioural, cognitive performance

Behavioral: Single Task
The section includes three tasks which involve upper and lower extremities, and cognitive functions, associated with low cognitive and motor load for their execution. Subjects are required to perform a single task, i.e. without the simultaneous execution of other tasks. Grasping(Motor Upper Limbs): The subject is required to reach an object's dominant limb and grab it. Walking(Motor Lower Limbs): It is required to carry 10 feet of walk. Attention(Cognitive): Signal detection task. The subject is required to detect acute sound between a series of serious sounds (Oddball Paradigm).

Behavioral: Dual Task
This section includes three tasks of different types (upper limb motor, lower limb motor, cognitive) that will be performed with a greater cognitive load. Elbow N-back (Dual Task Motor upper limbs): The subject is required to reconfigure the arrangement of the floppy disks on a different blade, by moving only one disk at a time and by putting a disk on another bigger disk, never on a smaller one. Walking + Nback (Dual Task Motor lower limbs): The subject is required to walk while subtracting from 100 to 3 in 3. Problem Solving (Dual Task Cognitive): The subject is subjected to a deductive logic puzzle.

Behavioral: Rest
At this stage, the HR and GSR signals will be recorded during a period of rest of 10 minutes. The subjects wear a pair of headphone for reducing the environmental sound noise. Through the headphones a sound indicates to the subject when recording starts and stops. Two separate recording of 5 minutes are performed, the first is performed while keeping eyes closed The two session are presented randomly to each different subject in order to prevent a bias due to order effect .




Primary Outcome Measures :
  1. Galvanic Skin Response [ Time Frame: 3 hours ]

    The GSR sensor measures the conductivity of the skin between the GSR diode contact points on the other side of the clasp, raised from the battery cover.

    Galvanic Skin Response data are acquired and stored in a connected device text file using a customised application able to acquire MS Band 2 GSR signal at a sample rate of 40 Hz, and expressed in microsiemens (µS).


  2. Heart Rate [ Time Frame: 3 hours ]

    The optical heart rate monitor of the Microsoft Band uses a light sensor to detect minor fluctuations in the wrist capillaries. The heart rate monitor is located on the back of the clasp.

    Heart Rate data are continuously acquired and stored in a connected device text file using a customised application able to acquire MS Band 2 HR signal at a sample rate of 2 Hz, together with a timestamp, and expressed in heart beats per minutes (bpm).


  3. Valence [ Time Frame: 3 hours ]

    Valence is measured using the Self-Assessment Manikin (SAM) (Hodes, Cook & Lang, 1985) to directly assess the valence, arousal, and dominance associated in response to an object or event. SAM Valence is a self assessment 7-point likert scale which ranges from a smiling, happy figure (score: 7) to a frowning, unhappy figure (score: 1) when representing the pleasure dimension.

    The scale is proposed after each stimuli is presented or task executed by the subjects, and the scores are collected through the psychology experiment design software Psychopy (Peirce, 2007), which collects also the subjects ID and the timestamp, while the band is worn by the subjects.


  4. Arousal [ Time Frame: 3 hours ]

    Arousal is measured using the Self-Assessment Manikin (SAM) (Hodes, Cook & Lang, 1985) to directly assess the valence, arousal, and dominance associated in response to an object or event. SAM Arousal is a self assessment 7-point likert scale which ranges from an excited, wide-eyed figure (score: 7) to a relaxed, sleepy figure (score: 1) for the arousal dimension.

    The scale is proposed after each stimuli is presented or task executed by the subjects, and the scores are collected through the psychology experiment design software Psychopy (Peirce, 2007), which collects also the subjects ID and the timestamp, while the band is worn by the subjects.




Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Parkinson's disease Group

Inclusion criteria:

- Diagnosis of idiopathic Parkinson's Disease according to the UK Brain Bank Criteria

Exclusion criteria:

  • Mini Mental State Examination < 24;
  • Inability to walk without aid (Hoen & Yahr Scale >3)

Stroke Group

Inclusion criteria:

- Ischemic attack diagnosis.

Exclusion criteria:

  • Mini Mental State Examination < 24;
  • Inability to walk without aid.

Healthy Subject Group

Inclusion criteria:

  • Age between 25 and 80;
  • Absence of neurologic disease;

Exclusion criteria:

- Mini Mental State Examination < 24.


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): NCT03425877


Contacts
Contact: Patrizio Sale, MD, PhD +393477526350 patrizio.sale@unipd.it
Contact: Giovanni Gentile, MSc +393282438545 giovanni.gentile@ospedalesancamillo.net

Locations
Italy
Department of Neuroscience, University of Padua Active, not recruiting
Padova, Italy, 35142
IRCCS San Camillo Hospital Recruiting
Venezia, Italy, 30126
Contact: Giovanni Gentile, MSc    3282438545    giovanni.gentile@ospedalesancamillo.net   
Sub-Investigator: Giovanni Gentile, MSc         
Sponsors and Collaborators
IRCCS San Camillo, Venezia, Italy
Università Politecnica delle Marche
University of Padua
Investigators
Principal Investigator: Patrizio Sale, MD, PhD IRCCS San Camillo Hospital, University Of Padua

Publications:
Harrivel, A. R., Liles, C., Stephens, C. L., Ellis, K. K., Prinzel, L. J., & Pope, A. T. (2016). Psychophysiological Sensing and State Classification for Attention Management in Commercial Aviation. In AIAA Infotech @ Aerospace. Reston, Virginia: American Institute of Aeronautics and Astronautics. http://doi.org/10.2514/6.2016-1490
Schaefer, A., Nils, F. F., Sanchez, X., & Philippot, P. (2010). Assessing the effectiveness of a large database of emotion-eliciting films: A new tool for emotion researchers. Cognition & Emotion, 24(7), 1153-1172. http://doi.org/10.1080/02699930903274322
Westman, M., & Eden, D. (1996). The inverted-U relationship between stress and performance: A field study. Work & Stress, 10(2), 165-173. http://doi.org/10.1080/02678379608256795

Responsible Party: Patrizio Sale, Consultant Physician, Rehabilitation physician, IRCCS San Camillo, Venezia, Italy
ClinicalTrials.gov Identifier: NCT03425877     History of Changes
Other Study ID Numbers: 2016.25
First Posted: February 8, 2018    Key Record Dates
Last Update Posted: February 8, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Patrizio Sale, IRCCS San Camillo, Venezia, Italy:
arousal, valence, emotion, heart rate variability, electrodermal activity, u-shape curve, performance, neurorehabilitation

Additional relevant MeSH terms:
Parkinson Disease
Nervous System Diseases
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases