Arousal Response Tool for Neurological Disease

Not Applicable

• Conditions: Stroke; Parkinson Disease; Healthy
• Interventions: Device: MS Band 2; Behavioral: Emotion Assessment; Behavioral: Single Task; Behavioral: Dual Task; Behavioral: Rest

• Registration Number: NCT03425877
• Lead Sponsor: 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.

Detailed Description

The context and the environment in which we act may interact significantly with our actions and with the property of our performance, leads to alterations of arousal states and psychophysiological stress responses.

Stress has typically been defined as a state that occurs when situation's demands are inconsistent with social, psychological and biological person's resources. Stress is an adaptive response direct to optimize the available resources to cope a given situation. However, when resources demand outstrips the individual's ability, stress has negative effects (distress). Stress effects are investigated along three domains: (1) at biological and neurophysiological modifications level, (2) at behavioral performance level and finally (3) through the subjective assessment (self-report questionnaire).

Many psychological theories have taken into account the Inverted-U shape model, in which arousal and performance are mutually reliant. There is an optimal level of arousal at which performance peaks whereas, at both lower or higher level than the optimal one, performance deteriorates .

Other thesis instead explain the different responses to stress and performance modifications in terms of cognitive resources, in particular the attentive and executive ones. Therefore, the measurement of stress involves the analysis of particular bio signals which are tied tightly to arousal such as Heart Rate (HR), Galvanic Skin Response (GSR) and electromyography (EMG), to which we should add behavioral assessment, cognitive load (in a range from single task to multi-tasking execution) and subjective assessment of one's own state of stress/distress.

Motor disability caused by neurological disorder is an important issue: every years 16 millions of people all over the world are affected by stroke and currently 33 million stroke survivor are affected by a serious acquired motor disability. Almost the whole of them are subjected to serious limitations of daily living activities and require constant assistance to their relatives.

Parkinson's Disease is the most common degenerative disorder of the central nervous system after Alzheimer's disease. Incidence rate for PD is about 18 per 100.000 person-years and it's one of the most important cause of motor disabilities in adult age with stroke.

Laboratory controlled research showed that stress response could changes psychophysiological parameters and signal (HR, GSR, EMG, EEG, etc...). A recent survey by Reinkensmeyer and colleagues (Reinkensmeyer et al., 2016) point out the relevance of computational approaches in neuro-rehabilitation which provide clear information about the neuromotor rehabilitation performance and its optimization thanks to feedback originate from analysis conducted on extensive motor and electrophysiological data.

With current technologies, many of which are available at a reduced cost, we are able to supervise on-line different aspects of our behavior, first of all the motor one. Equally important are all that technological supports which controls autonomic responses. Indeed, they highlight the relevance of individual internal response in context as the neuromotor rehabilitation one.

In such scenario, several questions still need a clear answer:

1. What are the triggering states to best cope with stressful situations and tasks?

2. What level of arousal is associated with the gradual increase of cognitive difficulties while carrying out a task?

3. Can the online feedback, on the patient's activation status, guide the work of the therapists and the patients themselves?

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.

1. Assess the psychophysical response;

1. Describe the configuration of physiological activation patterns.

2. Determine the interaction effect between task type and pathology.

2. Assess behavioral response;

1. Describe the performance,

2. Determine the interaction effect between task type and pathology.

3. Evaluate the subjective response.

a. Measure the degree of awareness of your state and your performance.

4. To highlight the relationships between psychophysiological patterns, behavioral performance and subjective response.

Study Timeline

• Study Start: 2017-04-22
• Study First Submitted: 2018-01-10
• Status Verified: 2018-02
• Study First Submitted QC: 2018-02-01
• Last Update Submitted: 2018-02-01
• Study First Posted: 2018-02-08
• Last Update Posted: 2018-02-08
• Primary Completion: 2018-04-30
• Study Completion: 2018-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Parkinson's disease Group	Emotion Assessment	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 .
Stroke Group	Emotion Assessment	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 .
Healthy Subjects Group	MS Band 2	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 .
Parkinson's disease Group	MS Band 2	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 .
Parkinson's disease Group	Single Task	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 .
Stroke Group	MS Band 2	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 .
Parkinson's disease Group	Dual Task	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 .
Stroke Group	Single Task	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 .
Stroke Group	Rest	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 .
Healthy Subjects Group	Emotion Assessment	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 .
Parkinson's disease Group	Rest	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 .
Stroke Group	Dual Task	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 .
Healthy Subjects Group	Rest	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 .
Healthy Subjects Group	Single Task	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 .
Healthy Subjects Group	Dual Task	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 .

Primary Outcome Measures

Name	Time	Method
Galvanic Skin Response	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).
Heart Rate	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).
Valence	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.
Arousal	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.

Trial Locations

Locations (2)

Department of Neuroscience, University of Padua; 🇮🇹 Padova, Italy

IRCCS San Camillo Hospital; 🇮🇹 Venezia, Italy