Clinical trial NCT03425877: Arousal Response Tool for Neurological Disease
Official title: Arousal Response Tool for Neurological Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parkinson Disease
Stroke
Healthy
Keywords: arousal, valence, emotion, heart rate variability, electrodermal activity, u-shape curve, performance, neurorehabilitation
Lead sponsor: IRCCS San Camillo, Venezia, Italy
Sponsor class: OTHER
Collaborators: name: Università Politecnica delle Marche
name: University of Padova
First posted: 2018-02-08
Enrollment: 45
Sex: ALL
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Eligibility 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.

Primary outcomes:
measure: Galvanic Skin Response
timeFrame: 3 hours
measure: Heart Rate
timeFrame: 3 hours
measure: Valence
timeFrame: 3 hours
measure: Arousal
timeFrame: 3 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Padova
country: Italy
facility: Department of Neuroscience, University of Padua
city: Venezia
country: Italy
facility: IRCCS San Camillo Hospital
Study officials:
affiliation: IRCCS San Camillo Hospital, University Of Padua
name: Patrizio Sale, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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