Arousal Response Tool for Neurological Disease (ART_ND)

I

IRCCS San Camillo, Venezia, Italy

Status

Unknown

Conditions

Healthy
Stroke
Parkinson Disease

Treatments

Behavioral: Single Task
Behavioral: Rest
Behavioral: Emotion Assessment
Behavioral: Dual Task
Device: MS Band 2

Study type

Interventional

Funder types

Other

Identifiers

NCT03425877
2016.25

Details and patient eligibility

About

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.

Full 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: What are the triggering states to best cope with stressful situations and tasks? What level of arousal is associated with the gradual increase of cognitive difficulties while carrying out a task? 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. Assess the psychophysical response; Describe the configuration of physiological activation patterns. Determine the interaction effect between task type and pathology. Assess behavioral response; Describe the performance, Determine the interaction effect between task type and pathology. Evaluate the subjective response. a. Measure the degree of awareness of your state and your performance. To highlight the relationships between psychophysiological patterns, behavioral performance and subjective response.

Enrollment

45 estimated patients

Sex

All

Ages

25+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose

Basic Science

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

45 participants in 3 patient groups

Parkinson's disease Group
Experimental group
Description:
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 .
Treatment:
Behavioral: Dual Task
Device: MS Band 2
Behavioral: Emotion Assessment
Behavioral: Rest
Behavioral: Single Task
Stroke Group
Experimental group
Description:
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 .
Treatment:
Behavioral: Dual Task
Device: MS Band 2
Behavioral: Emotion Assessment
Behavioral: Rest
Behavioral: Single Task
Healthy Subjects Group
Experimental group
Description:
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 .
Treatment:
Behavioral: Dual Task
Device: MS Band 2
Behavioral: Emotion Assessment
Behavioral: Rest
Behavioral: Single Task

Trial contacts and locations

2

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Central trial contact

Giovanni Gentile, MSc; Patrizio Sale, MD, PhD

Data sourced from clinicaltrials.gov

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