Arousal Response Tool for Neurological Disease

NCT03425877 | Unknown

• 1 other identifier: 2016.25
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 2

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.

Conditions

Parkinson Disease; Stroke; Healthy

Keywords

arousal, valence, emotion, heart rate variability, electrodermal activity, u-shape curve, performance, neurorehabilitation

Outcome Measures

Primary Outcomes (4)

• 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).

  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).

  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.

  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.

  3 hours

Study Arms (3)

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 .

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 .

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 .

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

Interventions

MS Band 2 DEVICE

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.

Also known as: Wristband (GSR, HR)

Healthy Subjects Group; Parkinson's disease Group; Stroke Group

Emotion Assessment BEHAVIORAL

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.

Also known as: Arousal report, behavioural, cognitive performance

Healthy Subjects Group; Parkinson's disease Group; Stroke Group

Single Task BEHAVIORAL

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).

Healthy Subjects Group; Parkinson's disease Group; Stroke Group

Dual Task BEHAVIORAL

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.

Healthy Subjects Group; Parkinson's disease Group; Stroke Group

Rest BEHAVIORAL

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 .

Healthy Subjects Group; Parkinson's disease Group; Stroke Group

Eligibility Criteria

• Age: 25 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Mini Mental State Examination \< 24;
• Inability to walk without aid (Hoen \& Yahr Scale \>3)
• Stroke Group
• \- Ischemic attack diagnosis.
• Mini Mental State Examination \< 24;
• Inability to walk without aid.
• Healthy Subject Group
• Age between 25 and 80;
• Absence of neurologic disease;
• \- Mini Mental State Examination \< 24.

Sponsors & Collaborators

• IRCCS San Camillo, Venezia, Italy: lead
• Università Politecnica delle Marche: collaborator
• University of Padova: collaborator

Study Sites (2)

Department of Neuroscience, University of Padua

Padua, 35142, Italy

ACTIVE NOT RECRUITING

IRCCS San Camillo Hospital

Venezia, 30126, Italy

RECRUITING

Related Publications (16)

• 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.

  PMID: 14768844 BACKGROUND

• Bradley 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.

  PMID: 7962581 BACKGROUND

• DUFFY 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.

  PMID: 13494613 BACKGROUND

• Feigin 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.

  PMID: 24449944 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 3834106 BACKGROUND

• Knaepen 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.

  PMID: 25617994 BACKGROUND

• Kuppens 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.

  PMID: 23231533 BACKGROUND

• Kyle 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.

  PMID: 24533429 BACKGROUND

• Mackersie 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.

  PMID: 27355761 BACKGROUND

• Reinkensmeyer 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.

  PMID: 27130577 BACKGROUND

• Salehi 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.

  PMID: 20884754 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 27132701 BACKGROUND

• 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

  BACKGROUND

• Wiberg H, Nilsson E, Linden P, Svanberg B, Poom L. Physiological responses related to moderate mental load during car driving in field conditions. Biol Psychol. 2015 May;108:115-25. doi: 10.1016/j.biopsycho.2015.03.017. Epub 2015 Apr 6.

  PMID: 25857673 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease; Stroke

Interventions

Galvanic Skin Response; potassium channel subfamily K member 3; RE1-silencing transcription factor

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Psychological Techniques; Investigative Techniques; Behavioral Disciplines and Activities; Electrophysiological Phenomena; Physiological Phenomena; Skin Physiological Phenomena; Integumentary System Physiological Phenomena

Study Officials

• Patrizio Sale, MD, PhD

  IRCCS San Camillo Hospital, University Of Padua

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrizio Sale, MD, PhD

CONTACT

+393477526350; patrizio.sale@unipd.it

Giovanni Gentile, MSc

CONTACT

+393282438545; giovanni.gentile@ospedalesancamillo.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Physician, Rehabilitation physician

Study Record Dates

• First Submitted: January 10, 2018
• First Posted: February 8, 2018
• Study Start: April 22, 2017
• Primary Completion: April 30, 2018
• Study Completion: December 31, 2018
• Last Updated: February 8, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)