Parkinson DiseaseART_NDNCT03425877
Arousal Response Tool for Neurological Disease
A study testing MS Band 2, Emotion Assessment and Single Task in people with Parkinson Disease and Stroke, run by IRCCS San Camillo, Venezia, Italy at 2 sites in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 25 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease, Stroke, Healthy
- What is being tested?
- MS Band 2, Emotion Assessment and Single Task
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 2 sitesItaly
- Study dates
- 22 Apr 2017to 31 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diagnosis of idiopathic Parkinson's Disease according to the UK Brain Bank Criteria
- Ischemic attack diagnosis.
- Age between 25 and 80;
- Absence of neurologic disease;
Who cannot join
- Mini Mental State Examination < 24;
- Inability to walk without aid (Hoen \& Yahr Scale >3)
- Stroke Group
- Mini Mental State Examination < 24;
- Inability to walk without aid.
- Healthy Subject Group
- Mini Mental State Examination < 24.
Trial locations and contacts
2 sites in 1 country.
Italy2 sites, 1 recruiting
- Active, not recruiting
Department of Neuroscience, University of Padua
Padova, 35142
- Recruiting
IRCCS San Camillo Hospital
Venezia, 30126
Giovanni Gentile, MSc, 3282438545, giovanni.gentile@ospedalesancamillo.net
Giovanni Gentile, MSc
About this study
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.
Read the 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:
- 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.
- Measure the degree of awareness of your state and your performance.
- To highlight the relationships between psychophysiological patterns, behavioral performance and subjective response.
- Conditions
- Parkinson Disease, Stroke, Healthy
- Being tested
- MS Band 2, Emotion Assessment, Single Task, Dual Task, Rest
- Keywords
- arousal, valence, emotion, heart rate variability, electrodermal activity, u-shape curve, performance, neurorehabilitation
- Medical subject headings
- Parkinson Disease, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MS Band 2Device
Also called Wristband (GSR, HR)
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.
Emotion AssessmentBehavioural
Also called Arousal report, behavioural, cognitive performance
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.
Single TaskBehavioural
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).
Dual TaskBehavioural
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.
RestBehavioural
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 .
| Study group | Role | What they receive |
|---|---|---|
| Parkinson's disease Group | Experimental | 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 . Receives: Device: MS Band 2; Behavioral: Emotion Assessment; Behavioral: Single Task; Behavioral: Dual Task; Behavioral: Rest |
| Stroke Group | Experimental | 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 . Receives: Device: MS Band 2; Behavioral: Emotion Assessment; Behavioral: Single Task; Behavioral: Dual Task; Behavioral: Rest |
| Healthy Subjects Group | Experimental | 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 . Receives: Device: MS Band 2; Behavioral: Emotion Assessment; Behavioral: Single Task; Behavioral: Dual Task; Behavioral: Rest |
What is being measured
The primary outcome is the main question the study is designed to answer.
Galvanic Skin Response
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).
Measured: 3 hours
Heart Rate
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).
Measured: 3 hours
Valence
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.
Measured: 3 hours
Arousal
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.
Measured: 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2018
- Study start22 Apr 2017
- Primary completion30 Apr 2018 (estimated)
- Study completion31 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Camillo, Venezia, Italy
- Sponsor type
- University, hospital or other
- Collaborators
- Università Politecnica delle Marche, University of Padova
- Responsible party
- Principal investigator, Patrizio Sale, IRCCS San Camillo, Venezia, Italy
- Investigators
- Patrizio Sale, MD, PhD, Principal investigator, IRCCS San Camillo Hospital, University Of Padua
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03425877
- Sponsor's protocol ID
- 2016.25
- Acronym
- ART_ND
- Status last verified
- Feb 2018
- First submitted
- 10 Jan 2018
- Last updated
- 8 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Arent SM, Landers DM. Arousal, anxiety, and performance: a reexamination of the Inverted-U hypothesis. Res Q Exerc Sport. 2003 Dec;74(4):436-44. doi: 10.1080/02701367.2003.10609113.
PubMed 14768844Bradley MM, Lang PJ. Measuring emotion: the Self-Assessment Manikin and the Semantic Differential. J Behav Ther Exp Psychiatry. 1994 Mar;25(1):49-59. doi: 10.1016/0005-7916(94)90063-9.
PubMed 7962581DUFFY E. The psychological significance of the concept of arousal or activation. Psychol Rev. 1957 Sep;64(5):265-75. doi: 10.1037/h0048837. No abstract available.
PubMed 13494613Feigin VL, Forouzanfar MH, Krishnamurthi R, Mensah GA, Connor M, Bennett DA, Moran AE, Sacco RL, Anderson L, Truelsen T, O'Donnell M, Venketasubramanian N, Barker-Collo S, Lawes CM, Wang W, Shinohara Y, Witt E, Ezzati M, Naghavi M, Murray C; Global Burden of Diseases, Injuries, and Risk Factors Study 2010 (GBD 2010) and the GBD Stroke Experts Group. Global and regional burden of stroke during 1990-2010: findings from the Global Burden of Disease Study 2010. Lancet. 2014 Jan 18;383(9913):245-54. doi: 10.1016/s0140-6736(13)61953-4.
PubMed 24449944Harrivel, 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
Kerr JH. The experience of arousal: a new basis for studying arousal effects in sport. J Sports Sci. 1985 Autumn;3(3):169-79. doi: 10.1080/02640418508729749.
PubMed 3834106Knaepen K, Marusic U, Crea S, Rodriguez Guerrero CD, Vitiello N, Pattyn N, Mairesse O, Lefeber D, Meeusen R. Psychophysiological response to cognitive workload during symmetrical, asymmetrical and dual-task walking. Hum Mov Sci. 2015 Apr;40:248-63. doi: 10.1016/j.humov.2015.01.001. Epub 2015 Jan 23.
PubMed 25617994Kuppens P, Tuerlinckx F, Russell JA, Barrett LF. The relation between valence and arousal in subjective experience. Psychol Bull. 2013 Jul;139(4):917-40. doi: 10.1037/a0030811. Epub 2012 Dec 10.
PubMed 23231533Kyle BN, McNeil DW. Autonomic arousal and experimentally induced pain: a critical review of the literature. Pain Res Manag. 2014 May-Jun;19(3):159-67. doi: 10.1155/2014/536859. Epub 2014 Feb 14.
PubMed 24533429Mackersie CL, Calderon-Moultrie N. Autonomic Nervous System Reactivity During Speech Repetition Tasks: Heart Rate Variability and Skin Conductance. Ear Hear. 2016 Jul-Aug;37 Suppl 1:118S-25S. doi: 10.1097/AUD.0000000000000305.
PubMed 27355761Reinkensmeyer DJ, Burdet E, Casadio M, Krakauer JW, Kwakkel G, Lang CE, Swinnen SP, Ward NS, Schweighofer N. Computational neurorehabilitation: modeling plasticity and learning to predict recovery. J Neuroeng Rehabil. 2016 Apr 30;13(1):42. doi: 10.1186/s12984-016-0148-3.
PubMed 27130577Salehi B, Cordero MI, Sandi C. Learning under stress: the inverted-U-shape function revisited. Learn Mem. 2010 Sep 30;17(10):522-30. doi: 10.1101/lm.1914110. Print 2010 Oct.
PubMed 20884754Schaefer, 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
Shelgikar AV, Anderson PF, Stephens MR. Sleep Tracking, Wearable Technology, and Opportunities for Research and Clinical Care. Chest. 2016 Sep;150(3):732-43. doi: 10.1016/j.chest.2016.04.016. Epub 2016 Apr 29.
PubMed 27132701Westman, 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
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arousal Response Tool for Neurological Disease
- ClinicalTrials.gov ID
- NCT03425877
- Acronym / sponsor ID
- ART_ND / 2016.25
- Conditions
- Parkinson Disease, Stroke, Healthy
- Keywords
- arousal, valence, emotion, heart rate variability, electrodermal activity, u-shape curve, performance, neurorehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- IRCCS San Camillo, Venezia, ItalyUniversity, hospital or other
- Collaborators
- Università Politecnica delle Marche, University of Padova
- Study start
- 22 Apr 2017 (actual)
- Primary completion
- 30 Apr 2018 (estimated)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 8 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- Measure the degree of awareness of your state and your performance.
- To highlight the relationships between psychophysiological patterns, behavioral performance and subjective response.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Parkinson's disease Group | Experimental | Device: MS Band 2, Behavioral: Emotion Assessment, Behavioral: Single Task, Behavioral: Dual Task, Behavioral: RestThe 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 | Experimental | Device: MS Band 2, Behavioral: Emotion Assessment, Behavioral: Single Task, Behavioral: Dual Task, Behavioral: RestThe 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 | Experimental | Device: MS Band 2, Behavioral: Emotion Assessment, Behavioral: Single Task, Behavioral: Dual Task, Behavioral: RestThe 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 . |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of idiopathic Parkinson's Disease according to the UK Brain Bank Criteria
- Ischemic attack diagnosis.
- Age between 25 and 80;
- Absence of neurologic disease;
Key exclusion criteria (7 listed)
- Mini Mental State Examination < 24;
- Inability to walk without aid (Hoen \& Yahr Scale >3)
- Stroke Group
- Mini Mental State Examination < 24;
- Inability to walk without aid.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MS Band 2Also: Wristband (GSR, HR)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. | Device | Healthy Subjects Group, Parkinson's disease Group, Stroke Group |
| Emotion AssessmentAlso: Arousal report, behavioural, cognitive performanceThe 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. | Behavioural | Healthy Subjects Group, Parkinson's disease Group, Stroke Group |
| Single TaskThe 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). | Behavioural | Healthy Subjects Group, Parkinson's disease Group, Stroke Group |
| Dual TaskThis 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. | Behavioural | Healthy Subjects Group, Parkinson's disease Group, Stroke Group |
| RestAt 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 . | Behavioural | Healthy Subjects Group, Parkinson's disease Group, Stroke Group |
Primary outcome
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).
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).
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2018.
- Background: PubMed 14768844Arent SM, Landers DM. Arousal, anxiety, and performance: a reexamination of the Inverted-U hypothesis. Res Q Exerc Sport. 2003 Dec;74(4):436-44. doi: 10.1080/02701367.2003.10609113.
- Background: PubMed 7962581Bradley MM, Lang PJ. Measuring emotion: the Self-Assessment Manikin and the Semantic Differential. J Behav Ther Exp Psychiatry. 1994 Mar;25(1):49-59. doi: 10.1016/0005-7916(94)90063-9.
- Background: PubMed 13494613DUFFY E. The psychological significance of the concept of arousal or activation. Psychol Rev. 1957 Sep;64(5):265-75. doi: 10.1037/h0048837. No abstract available.
- Background: PubMed 24449944Feigin VL, Forouzanfar MH, Krishnamurthi R, Mensah GA, Connor M, Bennett DA, Moran AE, Sacco RL, Anderson L, Truelsen T, O'Donnell M, Venketasubramanian N, Barker-Collo S, Lawes CM, Wang W, Shinohara Y, Witt E, Ezzati M, Naghavi M, Murray C; Global Burden of Diseases, Injuries, and Risk Factors Study 2010 (GBD 2010) and the GBD Stroke Experts Group. Global and regional burden of stroke during 1990-2010: findings from the Global Burden of Disease Study 2010. Lancet. 2014 Jan 18;383(9913):245-54. doi: 10.1016/s0140-6736(13)61953-4.
- BackgroundHarrivel, 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
- Background: PubMed 3834106Kerr JH. The experience of arousal: a new basis for studying arousal effects in sport. J Sports Sci. 1985 Autumn;3(3):169-79. doi: 10.1080/02640418508729749.
- Background: PubMed 25617994Knaepen K, Marusic U, Crea S, Rodriguez Guerrero CD, Vitiello N, Pattyn N, Mairesse O, Lefeber D, Meeusen R. Psychophysiological response to cognitive workload during symmetrical, asymmetrical and dual-task walking. Hum Mov Sci. 2015 Apr;40:248-63. doi: 10.1016/j.humov.2015.01.001. Epub 2015 Jan 23.
- Background: PubMed 23231533Kuppens P, Tuerlinckx F, Russell JA, Barrett LF. The relation between valence and arousal in subjective experience. Psychol Bull. 2013 Jul;139(4):917-40. doi: 10.1037/a0030811. Epub 2012 Dec 10.
- Background: PubMed 24533429Kyle BN, McNeil DW. Autonomic arousal and experimentally induced pain: a critical review of the literature. Pain Res Manag. 2014 May-Jun;19(3):159-67. doi: 10.1155/2014/536859. Epub 2014 Feb 14.
- Background: PubMed 27355761Mackersie CL, Calderon-Moultrie N. Autonomic Nervous System Reactivity During Speech Repetition Tasks: Heart Rate Variability and Skin Conductance. Ear Hear. 2016 Jul-Aug;37 Suppl 1:118S-25S. doi: 10.1097/AUD.0000000000000305.
- Background: PubMed 27130577Reinkensmeyer DJ, Burdet E, Casadio M, Krakauer JW, Kwakkel G, Lang CE, Swinnen SP, Ward NS, Schweighofer N. Computational neurorehabilitation: modeling plasticity and learning to predict recovery. J Neuroeng Rehabil. 2016 Apr 30;13(1):42. doi: 10.1186/s12984-016-0148-3.
- Background: PubMed 20884754Salehi B, Cordero MI, Sandi C. Learning under stress: the inverted-U-shape function revisited. Learn Mem. 2010 Sep 30;17(10):522-30. doi: 10.1101/lm.1914110. Print 2010 Oct.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrizio Sale, MD, PhD principal investigator
IRCCS San Camillo Hospital, University Of Padua
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MS Band 2, Emotion Assessment and Single Task in people with Parkinson Disease and Stroke, run by IRCCS San Camillo, Venezia, Italy at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patrizio Sale, MD, PhD (+393477526350, patrizio.sale@unipd.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Galvanic Skin Response (time frame: 3 hours). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03425877, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2018.