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Combination of Neck Muscle Vibration and tDCS With Conventional Rehabilitation in Neglect Patients (HEMISTIM)

Primary Purpose

Unilateral Spatial Neglect

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Neck muscle vibration
Neck muscle vibration + sham-tDCS
Neck muscle vibration + anodal-tDCS
Sponsored by
Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Unilateral Spatial Neglect focused on measuring Neck muscle vibration, tDCS, conventional rehabilitation, neglect

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • admitted in a post-stroke rehabilitation unit in the sub-acute phase (15 days to 6 months from the onset of stroke symptoms)
  • at least 18 years old
  • a first unilateral right hemispheric stroke
  • diagnosis of stroke confirmed by computed tomography (CT) or magnetic resonance imaging (MRI)
  • Behavioral Inattention Test (c-BIT), inferior or equal to 129

Exclusion Criteria:

  • unable to give informed consent
  • pregnant women
  • patients with skin lesions on the areas for electrode placement
  • having history of metal-in-cranial injury
  • epilepsy
  • vestibulo-cochlear illness
  • cardiac pacemaker

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    No Intervention

    Experimental

    Sham Comparator

    Experimental

    Arm Label

    Control patients

    left-NMV

    left-NMV + sham-tDCS

    left-NMV + anodal-tDCS

    Arm Description

    Patient receiving no additional treatment to conventional occupational therapy sessions

    Patient will be equipped with vibratory stimulators during conventional occupational therapy sessions. Only the left-side NMV vibrator will be activated.

    Patient will be equipped with vibratory stimulators and with electrodes form sham-tDCS during conventional occupational therapy sessions. Only the left-side NMV vibrator will be activated.

    Patient will be equipped with vibratory stimulators and with electrodes for tDCS during conventional occupational therapy sessions. Only the left-side NMV vibrator will be activated.

    Outcomes

    Primary Outcome Measures

    Catherine Bergego Scale
    Functional scale assessing unilateral spatial neglect severity in daily life situations. This is a score on 30. The higher the score, the severe the unilateral spatial neglect
    Catherine Bergego Scale
    Functional scale assessing unilateral spatial neglect severity in daily life situations. This is a score on 30. The higher the score, the severe the unilateral spatial neglect
    Catherine Bergego Scale
    Functional scale assessing unilateral spatial neglect severity in daily life situations. This is a score on 30. The higher the score, the severe the unilateral spatial neglect
    Catherine Bergego Scale
    Functional scale assessing unilateral spatial neglect severity in daily life situations. This is a score on 30. The higher the score, the severe the unilateral spatial neglect
    Catherine Bergego Scale
    Functional scale assessing unilateral spatial neglect severity in daily life situations. This is a score on 30. The higher the score, the severe the unilateral spatial neglect

    Secondary Outcome Measures

    Fluff test
    Investigating personal neglect with targets sticked on patients' clothes. The number of targets removed targets will be counted in order to calculate a score of personal neglect expressed as the difference of percentages of targets found on each side of the body (left-right), this value becoming more negative with the severity of personal neglect.
    Fluff test
    Investigating personal neglect with targets sticked on patients' clothes. The number of targets removed targets will be counted in order to calculate a score of personal neglect expressed as the difference of percentages of targets found on each side of the body (left-right), this value becoming more negative with the severity of personal neglect.
    Fluff test
    Investigating personal neglect with targets sticked on patients' clothes. The number of targets removed targets will be counted in order to calculate a score of personal neglect expressed as the difference of percentages of targets found on each side of the body (left-right), this value becoming more negative with the severity of personal neglect.
    Fluff test
    Investigating personal neglect with targets sticked on patients' clothes. The number of targets removed targets will be counted in order to calculate a score of personal neglect expressed as the difference of percentages of targets found on each side of the body (left-right), this value becoming more negative with the severity of personal neglect.
    Fluff test
    Investigating personal neglect with targets sticked on patients' clothes. The number of targets removed targets will be counted in order to calculate a score of personal neglect expressed as the difference of percentages of targets found on each side of the body (left-right), this value becoming more negative with the severity of personal neglect.
    Gainotti's drawing copying test
    Informs us on two kinds of peri-personal neglect referring to distinct disturbances of involved mental representations involved : space-centered neglect (egocentric) and object-centered neglect (allocentric).
    Gainotti's drawing copying test
    Informs us on two kinds of peri-personal neglect referring to distinct disturbances of involved mental representations involved : space-centered neglect (egocentric) and object-centered neglect (allocentric).
    Gainotti's drawing copying test
    Informs us on two kinds of peri-personal neglect referring to distinct disturbances of involved mental representations involved : space-centered neglect (egocentric) and object-centered neglect (allocentric).
    Gainotti's drawing copying test
    Informs us on two kinds of peri-personal neglect referring to distinct disturbances of involved mental representations involved : space-centered neglect (egocentric) and object-centered neglect (allocentric).
    Gainotti's drawing copying test
    Informs us on two kinds of peri-personal neglect referring to distinct disturbances of involved mental representations involved : space-centered neglect (egocentric) and object-centered neglect (allocentric).
    The Map of France test
    The number of cities mentioned will be counted on either side of a median line drawn vertically through the center of France. A mental evocation score will be calculated as the ratio of the number of cities on each side of this axis (left/right). The higher the score, the better the performance.
    The Map of France test
    The number of cities mentioned will be counted on either side of a median line drawn vertically through the center of France. A mental evocation score will be calculated as the ratio of the number of cities on each side of this axis (left/right). The higher the score, the better the performance.
    The Map of France test
    The number of cities mentioned will be counted on either side of a median line drawn vertically through the center of France. A mental evocation score will be calculated as the ratio of the number of cities on each side of this axis (left/right). The higher the score, the better the performance.
    The Map of France test
    The number of cities mentioned will be counted on either side of a median line drawn vertically through the center of France. A mental evocation score will be calculated as the ratio of the number of cities on each side of this axis (left/right). The higher the score, the better the performance.
    The Map of France test
    The number of cities mentioned will be counted on either side of a median line drawn vertically through the center of France. A mental evocation score will be calculated as the ratio of the number of cities on each side of this axis (left/right). The higher the score, the better the performance.
    The Subjective Straight-Ahead test
    Its investigates the accuracy of egocentric perception. EThe egocentric perception will be expressed as the mean error of 20 successive trials, after measuring for each trial the angular difference between the measured angles of the hand pointed towards SSA direction and the objective straight-ahead direction of the patient's body. A higher score indicates a less accurate egocentric perception.
    The Subjective Straight-Ahead test
    Its investigates the accuracy of egocentric perception. EThe egocentric perception will be expressed as the mean error of 20 successive trials, after measuring for each trial the angular difference between the measured angles of the hand pointed towards SSA direction and the objective straight-ahead direction of the patient's body. A higher score indicates a less accurate egocentric perception.
    The Subjective Straight-Ahead test
    Its investigates the accuracy of egocentric perception. EThe egocentric perception will be expressed as the mean error of 20 successive trials, after measuring for each trial the angular difference between the measured angles of the hand pointed towards SSA direction and the objective straight-ahead direction of the patient's body. A higher score indicates a less accurate egocentric perception.
    The Subjective Straight-Ahead test
    Its investigates the accuracy of egocentric perception. EThe egocentric perception will be expressed as the mean error of 20 successive trials, after measuring for each trial the angular difference between the measured angles of the hand pointed towards SSA direction and the objective straight-ahead direction of the patient's body. A higher score indicates a less accurate egocentric perception.
    The Subjective Straight-Ahead test
    Its investigates the accuracy of egocentric perception. EThe egocentric perception will be expressed as the mean error of 20 successive trials, after measuring for each trial the angular difference between the measured angles of the hand pointed towards SSA direction and the objective straight-ahead direction of the patient's body. A higher score indicates a less accurate egocentric perception.
    The Wheelchair navigation test
    Investigating spatial navigation skills and extra-personal neglect. The ride will be carried out once in each direction (A-B and B-A) to balance the number of obstacles and turns to the left and right. The time taken to finish the course will be measured and the number of bumps counted. Navigation quality will also be observed qualitatively (obstacle avoidance, goal strategy, perseverations).
    The Wheelchair navigation test
    Investigating spatial navigation skills and extra-personal neglect. The ride will be carried out once in each direction (A-B and B-A) to balance the number of obstacles and turns to the left and right. The time taken to finish the course will be measured and the number of bumps counted. Navigation quality will also be observed qualitatively (obstacle avoidance, goal strategy, perseverations).
    The Wheelchair navigation test
    Investigating spatial navigation skills and extra-personal neglect. The ride will be carried out once in each direction (A-B and B-A) to balance the number of obstacles and turns to the left and right. The time taken to finish the course will be measured and the number of bumps counted. Navigation quality will also be observed qualitatively (obstacle avoidance, goal strategy, perseverations).
    The Wheelchair navigation test
    Investigating spatial navigation skills and extra-personal neglect. The ride will be carried out once in each direction (A-B and B-A) to balance the number of obstacles and turns to the left and right. The time taken to finish the course will be measured and the number of bumps counted. Navigation quality will also be observed qualitatively (obstacle avoidance, goal strategy, perseverations).
    The Wheelchair navigation test
    Investigating spatial navigation skills and extra-personal neglect. The ride will be carried out once in each direction (A-B and B-A) to balance the number of obstacles and turns to the left and right. The time taken to finish the course will be measured and the number of bumps counted. Navigation quality will also be observed qualitatively (obstacle avoidance, goal strategy, perseverations).

    Full Information

    First Posted
    February 21, 2022
    Last Updated
    June 3, 2022
    Sponsor
    Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est
    Collaborators
    Université de Lorraine, DevAH (EA3450), Nancy, France, Union de Gestion des Etablissements des Caisses d'Assurance Maladie - PACA, Institut Régional de Médecine Physique et de Réadaptation de Nancy - Etablissement de Lay Saint Christophe
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05281302
    Brief Title
    Combination of Neck Muscle Vibration and tDCS With Conventional Rehabilitation in Neglect Patients
    Acronym
    HEMISTIM
    Official Title
    Innovative Therapy Combining Neck Muscle Vibration and Transcranial Direct Current Stimulation in Association With Conventional Rehabilitation in Left Unilateral Spatial Neglect Patients: HEMISTIM Protocol
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 2024 (Anticipated)
    Primary Completion Date
    October 2027 (Anticipated)
    Study Completion Date
    May 2028 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est
    Collaborators
    Université de Lorraine, DevAH (EA3450), Nancy, France, Union de Gestion des Etablissements des Caisses d'Assurance Maladie - PACA, Institut Régional de Médecine Physique et de Réadaptation de Nancy - Etablissement de Lay Saint Christophe

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    BACKGROUND: Unilateral spatial neglect (USN) rehabilitation remains a challenge and requires the development of new methods that can be easily integrated into conventional practice. The aim of the HEMISTIM protocol is to assess immediate and long-term functional outcomes and neuropsychological aspects of recovery, induced by an innovative association of left-side neck-muscle vibration (NMV) and anodal transcranial Direct Current Stimulation (tDCS) on the ipsilesional posterior parietal cortex during occupational therapy sessions in patients with left USN. METHODS: Participants will be randomly assigned to 4 groups: control, Left-NMV, Left-NMV + sham-tDCS or Left-NMV + anodal-tDCS. NMV will be applied during the first 15 minutes of occupational therapy and tDCS will be applied for 20 minutes, starting 5 minutes before, three days a week for three weeks. USN will be assessed at baseline, just at the end of the first experimental session, after the first and third weeks of the protocol and three weeks after its ending. DISCUSSION: Left NMV, by activating multisensory integration neuronal networks, might enhance beneficial effects obtained by conventional occupational therapy sessions since interesting post-effects were shown when it was combined with voluntary upper limb movements. The investigators expect to reinforce lasting intermodal recalibration through LTP-like plasticity induced by anodal tDCS. The HEMISTIM protocol represents a therapeutic innovation associated to conventional practice that could provide a partial solution to the rehabilitation challenges of the USN syndrome and some insights to its underlying mechanisms.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Unilateral Spatial Neglect
    Keywords
    Neck muscle vibration, tDCS, conventional rehabilitation, neglect

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    InvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Control patients
    Arm Type
    No Intervention
    Arm Description
    Patient receiving no additional treatment to conventional occupational therapy sessions
    Arm Title
    left-NMV
    Arm Type
    Experimental
    Arm Description
    Patient will be equipped with vibratory stimulators during conventional occupational therapy sessions. Only the left-side NMV vibrator will be activated.
    Arm Title
    left-NMV + sham-tDCS
    Arm Type
    Sham Comparator
    Arm Description
    Patient will be equipped with vibratory stimulators and with electrodes form sham-tDCS during conventional occupational therapy sessions. Only the left-side NMV vibrator will be activated.
    Arm Title
    left-NMV + anodal-tDCS
    Arm Type
    Experimental
    Arm Description
    Patient will be equipped with vibratory stimulators and with electrodes for tDCS during conventional occupational therapy sessions. Only the left-side NMV vibrator will be activated.
    Intervention Type
    Device
    Intervention Name(s)
    Neck muscle vibration
    Intervention Description
    Patient will receive neck muscle vibration during the first 15 minutes of occupational therapy. Vibratory stimulators will be fixed bilaterally on the skin over the belly of the trapezius muscles and fastened with straps. Only the left vibrator will be activated.
    Intervention Type
    Device
    Intervention Name(s)
    Neck muscle vibration + sham-tDCS
    Intervention Description
    Patient will receive neck muscle vibration during the first 15 minutes of occupational therapy.. Vibratory stimulators will be fixed bilaterally on the skin over the belly of the trapezius muscles and fastened with straps. Only the left vibrator will be activated. Moreover, tDCS will be applied using an electrical stimulator (DC-STIMULATOR®, NeuroCare, Illmenau, Germany) through large saline-soaked sponge surface electrodes placed as follows: anode over the right (ipsilesional) posterior parietal cortex (P4 according to the International 10-20 EEG electrode placement system) and cathode over the left supraorbital region. The tDCS will be automatically turned off after 20 seconds. This allows the reproduction of the initial mild itching sensation at the beginning of active tDCS, thus ensuring that the patient stays blind to the activation status of the device.
    Intervention Type
    Device
    Intervention Name(s)
    Neck muscle vibration + anodal-tDCS
    Intervention Description
    Patient will receive neck muscle vibration during the first 15 minutes of occupational therapy. Vibratory stimulators will be fixed bilaterally on the skin over the belly of the trapezius muscles and fastened with straps. Only the left vibrator will be activated. Moreover, tDCS will be applied using an electrical stimulator (DC-STIMULATOR®, NeuroCare, Illmenau, Germany) through large saline-soaked sponge surface electrodes placed as follows: anode over the right (ipsilesional) posterior parietal cortex (P4 according to the International 10-20 EEG electrode placement system) and cathode over the left supraorbital region. A continuous 2 mA current will be delivered for 20 minutes simultaneously to NMV stimulation. The stimulation will begin 5 minutes before the beginning of occupational therapy.
    Primary Outcome Measure Information:
    Title
    Catherine Bergego Scale
    Description
    Functional scale assessing unilateral spatial neglect severity in daily life situations. This is a score on 30. The higher the score, the severe the unilateral spatial neglect
    Time Frame
    at the end of the first week of inclusion
    Title
    Catherine Bergego Scale
    Description
    Functional scale assessing unilateral spatial neglect severity in daily life situations. This is a score on 30. The higher the score, the severe the unilateral spatial neglect
    Time Frame
    Immediately following first session of occupational therapy.
    Title
    Catherine Bergego Scale
    Description
    Functional scale assessing unilateral spatial neglect severity in daily life situations. This is a score on 30. The higher the score, the severe the unilateral spatial neglect
    Time Frame
    after the first week of protocol
    Title
    Catherine Bergego Scale
    Description
    Functional scale assessing unilateral spatial neglect severity in daily life situations. This is a score on 30. The higher the score, the severe the unilateral spatial neglect
    Time Frame
    after the third week of protocol
    Title
    Catherine Bergego Scale
    Description
    Functional scale assessing unilateral spatial neglect severity in daily life situations. This is a score on 30. The higher the score, the severe the unilateral spatial neglect
    Time Frame
    3 weeks after the last session of intervention
    Secondary Outcome Measure Information:
    Title
    Fluff test
    Description
    Investigating personal neglect with targets sticked on patients' clothes. The number of targets removed targets will be counted in order to calculate a score of personal neglect expressed as the difference of percentages of targets found on each side of the body (left-right), this value becoming more negative with the severity of personal neglect.
    Time Frame
    at the end of the first week of inclusion
    Title
    Fluff test
    Description
    Investigating personal neglect with targets sticked on patients' clothes. The number of targets removed targets will be counted in order to calculate a score of personal neglect expressed as the difference of percentages of targets found on each side of the body (left-right), this value becoming more negative with the severity of personal neglect.
    Time Frame
    Immediately following first session of occupational therapy.
    Title
    Fluff test
    Description
    Investigating personal neglect with targets sticked on patients' clothes. The number of targets removed targets will be counted in order to calculate a score of personal neglect expressed as the difference of percentages of targets found on each side of the body (left-right), this value becoming more negative with the severity of personal neglect.
    Time Frame
    after the first week of protocol
    Title
    Fluff test
    Description
    Investigating personal neglect with targets sticked on patients' clothes. The number of targets removed targets will be counted in order to calculate a score of personal neglect expressed as the difference of percentages of targets found on each side of the body (left-right), this value becoming more negative with the severity of personal neglect.
    Time Frame
    after the third week of protocol
    Title
    Fluff test
    Description
    Investigating personal neglect with targets sticked on patients' clothes. The number of targets removed targets will be counted in order to calculate a score of personal neglect expressed as the difference of percentages of targets found on each side of the body (left-right), this value becoming more negative with the severity of personal neglect.
    Time Frame
    3 weeks after the last session of intervention
    Title
    Gainotti's drawing copying test
    Description
    Informs us on two kinds of peri-personal neglect referring to distinct disturbances of involved mental representations involved : space-centered neglect (egocentric) and object-centered neglect (allocentric).
    Time Frame
    at the end of the first week of inclusion
    Title
    Gainotti's drawing copying test
    Description
    Informs us on two kinds of peri-personal neglect referring to distinct disturbances of involved mental representations involved : space-centered neglect (egocentric) and object-centered neglect (allocentric).
    Time Frame
    Immediately following first session of occupational therapy.
    Title
    Gainotti's drawing copying test
    Description
    Informs us on two kinds of peri-personal neglect referring to distinct disturbances of involved mental representations involved : space-centered neglect (egocentric) and object-centered neglect (allocentric).
    Time Frame
    after the first week of protocol
    Title
    Gainotti's drawing copying test
    Description
    Informs us on two kinds of peri-personal neglect referring to distinct disturbances of involved mental representations involved : space-centered neglect (egocentric) and object-centered neglect (allocentric).
    Time Frame
    After the third week of protocol
    Title
    Gainotti's drawing copying test
    Description
    Informs us on two kinds of peri-personal neglect referring to distinct disturbances of involved mental representations involved : space-centered neglect (egocentric) and object-centered neglect (allocentric).
    Time Frame
    3 weeks after the last session of intervention
    Title
    The Map of France test
    Description
    The number of cities mentioned will be counted on either side of a median line drawn vertically through the center of France. A mental evocation score will be calculated as the ratio of the number of cities on each side of this axis (left/right). The higher the score, the better the performance.
    Time Frame
    Immediately following first session of occupational therapy.
    Title
    The Map of France test
    Description
    The number of cities mentioned will be counted on either side of a median line drawn vertically through the center of France. A mental evocation score will be calculated as the ratio of the number of cities on each side of this axis (left/right). The higher the score, the better the performance.
    Time Frame
    After the first experimental session
    Title
    The Map of France test
    Description
    The number of cities mentioned will be counted on either side of a median line drawn vertically through the center of France. A mental evocation score will be calculated as the ratio of the number of cities on each side of this axis (left/right). The higher the score, the better the performance.
    Time Frame
    After the first week of protocol
    Title
    The Map of France test
    Description
    The number of cities mentioned will be counted on either side of a median line drawn vertically through the center of France. A mental evocation score will be calculated as the ratio of the number of cities on each side of this axis (left/right). The higher the score, the better the performance.
    Time Frame
    After the third week of protocol
    Title
    The Map of France test
    Description
    The number of cities mentioned will be counted on either side of a median line drawn vertically through the center of France. A mental evocation score will be calculated as the ratio of the number of cities on each side of this axis (left/right). The higher the score, the better the performance.
    Time Frame
    3 weeks after the last session of intervention
    Title
    The Subjective Straight-Ahead test
    Description
    Its investigates the accuracy of egocentric perception. EThe egocentric perception will be expressed as the mean error of 20 successive trials, after measuring for each trial the angular difference between the measured angles of the hand pointed towards SSA direction and the objective straight-ahead direction of the patient's body. A higher score indicates a less accurate egocentric perception.
    Time Frame
    At the end of the first week of inclusion
    Title
    The Subjective Straight-Ahead test
    Description
    Its investigates the accuracy of egocentric perception. EThe egocentric perception will be expressed as the mean error of 20 successive trials, after measuring for each trial the angular difference between the measured angles of the hand pointed towards SSA direction and the objective straight-ahead direction of the patient's body. A higher score indicates a less accurate egocentric perception.
    Time Frame
    Immediately following first session of occupational therapy.
    Title
    The Subjective Straight-Ahead test
    Description
    Its investigates the accuracy of egocentric perception. EThe egocentric perception will be expressed as the mean error of 20 successive trials, after measuring for each trial the angular difference between the measured angles of the hand pointed towards SSA direction and the objective straight-ahead direction of the patient's body. A higher score indicates a less accurate egocentric perception.
    Time Frame
    After the first week of protocol
    Title
    The Subjective Straight-Ahead test
    Description
    Its investigates the accuracy of egocentric perception. EThe egocentric perception will be expressed as the mean error of 20 successive trials, after measuring for each trial the angular difference between the measured angles of the hand pointed towards SSA direction and the objective straight-ahead direction of the patient's body. A higher score indicates a less accurate egocentric perception.
    Time Frame
    After the third week of protocol
    Title
    The Subjective Straight-Ahead test
    Description
    Its investigates the accuracy of egocentric perception. EThe egocentric perception will be expressed as the mean error of 20 successive trials, after measuring for each trial the angular difference between the measured angles of the hand pointed towards SSA direction and the objective straight-ahead direction of the patient's body. A higher score indicates a less accurate egocentric perception.
    Time Frame
    3 weeks after the last session of intervention
    Title
    The Wheelchair navigation test
    Description
    Investigating spatial navigation skills and extra-personal neglect. The ride will be carried out once in each direction (A-B and B-A) to balance the number of obstacles and turns to the left and right. The time taken to finish the course will be measured and the number of bumps counted. Navigation quality will also be observed qualitatively (obstacle avoidance, goal strategy, perseverations).
    Time Frame
    At the end of the first week of inclusion
    Title
    The Wheelchair navigation test
    Description
    Investigating spatial navigation skills and extra-personal neglect. The ride will be carried out once in each direction (A-B and B-A) to balance the number of obstacles and turns to the left and right. The time taken to finish the course will be measured and the number of bumps counted. Navigation quality will also be observed qualitatively (obstacle avoidance, goal strategy, perseverations).
    Time Frame
    Immediately following first session of occupational therapy.
    Title
    The Wheelchair navigation test
    Description
    Investigating spatial navigation skills and extra-personal neglect. The ride will be carried out once in each direction (A-B and B-A) to balance the number of obstacles and turns to the left and right. The time taken to finish the course will be measured and the number of bumps counted. Navigation quality will also be observed qualitatively (obstacle avoidance, goal strategy, perseverations).
    Time Frame
    After the first week of protocol
    Title
    The Wheelchair navigation test
    Description
    Investigating spatial navigation skills and extra-personal neglect. The ride will be carried out once in each direction (A-B and B-A) to balance the number of obstacles and turns to the left and right. The time taken to finish the course will be measured and the number of bumps counted. Navigation quality will also be observed qualitatively (obstacle avoidance, goal strategy, perseverations).
    Time Frame
    After the third week of protocol
    Title
    The Wheelchair navigation test
    Description
    Investigating spatial navigation skills and extra-personal neglect. The ride will be carried out once in each direction (A-B and B-A) to balance the number of obstacles and turns to the left and right. The time taken to finish the course will be measured and the number of bumps counted. Navigation quality will also be observed qualitatively (obstacle avoidance, goal strategy, perseverations).
    Time Frame
    3 weeks after the last session of intervention

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: admitted in a post-stroke rehabilitation unit in the sub-acute phase (15 days to 6 months from the onset of stroke symptoms) at least 18 years old a first unilateral right hemispheric stroke diagnosis of stroke confirmed by computed tomography (CT) or magnetic resonance imaging (MRI) Behavioral Inattention Test (c-BIT), inferior or equal to 129 Exclusion Criteria: unable to give informed consent pregnant women patients with skin lesions on the areas for electrode placement having history of metal-in-cranial injury epilepsy vestibulo-cochlear illness cardiac pacemaker
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jonathan Pierret, PhD
    Phone
    +33 3 83 52 67 61
    Email
    jonath.pierret@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Hadrien Ceyte, PhD, HDR
    Organizational Affiliation
    Université de Lorraine, DevAH (EA3450), Nancy, France
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Combination of Neck Muscle Vibration and tDCS With Conventional Rehabilitation in Neglect Patients

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