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The Study of a Neural Interface and a Neurostimulation in the Rehabilitation of Upper Limb Movement Impairments.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05115149
Recruitment Status : Recruiting
First Posted : November 10, 2021
Last Update Posted : November 10, 2021
Sponsor:
Collaborators:
Samara State Medical University
Samara Regional Clinical Hospital named after V.D. Seredavin
Kazan Federal University
Far Eastern Federal University
EirMED Rehabilitation Center
Pavlov Institute of Physiology, Russian Academy of Science
IT Universe LLC
VIBRAINT RUS LLC
Information provided by (Responsible Party):
Skolkovo Institute of Science and Technology

Brief Summary:

The aim of the study is to investigate the effectiveness of a new rehabilitation technology for paralysis that occurs after stroke or spinal cord injury. The research will jointly use a prototype neurorehabilitation orthosis, in which a robotic device moves a paralyzed arm at the command of a non-invasive brain-computer interface to perform a game life-like task augmented using a virtual-reality display, as well as an electrical stimulation device that activates the spinal cord and/or muscles of the paralyzed arm.

Investigators expect that a portion of the patients participating in the study will have an improvement in arm mobility by the end of the study.

Participants who express their special written consent will have venous blood tests conducted three times for subsequent analysis of lipid biomarkers, in order to further evaluate the effectiveness of rehabilitation methods based on biochemical analysis.


Condition or disease Intervention/treatment Phase
Stroke Spinal Cord Injuries Device: VIBRAINT RehUp robotic orthosis Procedure: tSCS during the exercise Procedure: tSCS prior to the exercise Device: Neostim-5 Procedure: Exercise Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants are categorised by the type of injury (spinal cord injury or stroke) and by the rehabilitation stage (early stage, later stage). Within those categories participants are randomly assigned to experimental and delay (control) groups.
Masking: Double (Participant, Outcomes Assessor)
Masking Description: Patients rehabilitation outcomes will be assessed by blinded assessors. In Neva Arm some patients will receive sham tSCS, with gradient decrease of the stimulation intensity from threshold level to 0 during one minute, as described in PMID 29335430 and PMID: 31996455
Primary Purpose: Treatment
Official Title: The Study on the еffectiveness of the Integration of a Device Based on a Neural Interface and Neurostimulation of the Spinal Cord in the Rehabilitation of Patients With Upper Limb Movement Impairments Due to Neurological Disorders.
Actual Study Start Date : October 1, 2021
Estimated Primary Completion Date : December 20, 2022
Estimated Study Completion Date : December 20, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Volga: tSCS during the exercise
Stimulation during the excercise
Device: VIBRAINT RehUp robotic orthosis
VIBRAINT RehUp robotic orthosis is a robotic arm that supports movement of a paralyzed arm. The robotic device is connected to a BCI. VIBRAINT RehUp software decodes imagery of a movement of the paralyzed arm and/or selective attention to the target of movement.

Procedure: tSCS during the exercise

During the exercise transcutaneous stimulation of the spinal cord and, in some cases, peripheral nerves is also performed.

tSCS is performed with the localization of electrodes between the spinous processes of the vertebrae C2-C3 and C5-C6, anodes - above the clavicles or above the crests of the iliac bones, bipolar or monopolar pulses with a frequency of 30 Hz, modulated with a frequency of 5 Hz.


Device: Neostim-5
Neostim-5 is intended for the transcutaneous spinal cord noninvasive stimulation from 0 up to 250 2 mA (step 1mA). Neostim allows to stimulate up to five different segments of spinal cord. The device can be synchronised with other devices.

Procedure: Exercise
The partcipant recieves a mental task - to imagine a movement or to concentrate on the goal. Upon successful completion of the given mental task, the VIBRAINT RehUp robotic exerciser moves the paralyzed limb. In the presence of muscular activity in a limb, an additional condition for the start of movement can be EMG activity in an agonist muscle assisting the robot movement.

Experimental: Neva: tSCS prior to the exercise
Stimulation prior to the action
Device: VIBRAINT RehUp robotic orthosis
VIBRAINT RehUp robotic orthosis is a robotic arm that supports movement of a paralyzed arm. The robotic device is connected to a BCI. VIBRAINT RehUp software decodes imagery of a movement of the paralyzed arm and/or selective attention to the target of movement.

Procedure: tSCS prior to the exercise

Prior to the exercise transcutaneous stimulation of the spinal cord and, in some cases, peripheral nerves is also performed.

tSCS is performed with the localization of electrodes between the spinous processes of the vertebrae C2-C3 and C5-C6, anodes - above the clavicles or above the crests of the iliac bones, bipolar or monopolar pulses with a frequency of 30 Hz, modulated with a frequency of 5 Hz.


Device: Neostim-5
Neostim-5 is intended for the transcutaneous spinal cord noninvasive stimulation from 0 up to 250 2 mA (step 1mA). Neostim allows to stimulate up to five different segments of spinal cord. The device can be synchronised with other devices.

Procedure: Exercise
The partcipant recieves a mental task - to imagine a movement or to concentrate on the goal. Upon successful completion of the given mental task, the VIBRAINT RehUp robotic exerciser moves the paralyzed limb. In the presence of muscular activity in a limb, an additional condition for the start of movement can be EMG activity in an agonist muscle assisting the robot movement.




Primary Outcome Measures :
  1. Change from Baseline Fugl-Meyer scale for the upper limb after the rehabilitation procedures [ Time Frame: 2 weeks ]
    Dynamics according to the Fugl-Meyer Assessment for Upper Extremity parts A-D (FMA-UE A-D) that assesses motor function in a range from 0 (worst score) to 66 (best score). Details aviable at https://www.gu.se/en/neuroscience-physiology/fugl-meyer-assessment.

  2. Change from Baseline Fugl-Meyer scale for the upper limb in four weeks after the rehabilitation procedures [ Time Frame: up to 6 weeks ]
    Dynamics according to the Fugl-Meyer Assessment for Upper Extremity parts A-D (FMA-UE A-D) that assesses motor function in a range from 0 (worst score) to 66 (best score). Details aviable at https://www.gu.se/en/neuroscience-physiology/fugl-meyer-assessment.

  3. Change from Baseline Action Research Arm Test after the rehabilitation procedures [ Time Frame: 2 weeks ]
    Dynamics according to the Action Research Arm Test (ARAT) that assesses motor function in a range from 0 (worst score) to 57 (best score). Details available at https://www.physiopedia.com/Action_Research_Arm_Test_(ARAT) .

  4. Change from Baseline Action Research Arm Test in four weeks after the rehabilitation procedures [ Time Frame: up to 6 weeks ]
    Dynamics according to the Action Research Arm Test (ARAT) that assesses motor function in a range from 0 (worst score) to 57 (best score). Details available at https://www.physiopedia.com/Action_Research_Arm_Test_(ARAT) .


Secondary Outcome Measures :
  1. Change from Baseline Accuracy of BCI tasks after the rehabilitation procedures [ Time Frame: 2 weeks ]
    Dynamics of accuracy for BCI tasks (% of correctly completed tasks)

  2. Change from Baseline in the Accuracy of BCI tasks in four weeks after the rehabilitation procedures [ Time Frame: up to 6 weeks ]
    Dynamics of accuracy for BCI tasks (% of correctly completed tasks)

  3. Change from Baseline Rivermead Mobility Index after the rehabilitation procedures [ Time Frame: 2 weeks ]
    Dynamics according to the Rivermead Mobility Index (RMI) that assesses overall mobility in a range from 0 (worst score) to 15 (best score). Details available at https://www.physio-pedia.com/Rivermead_Mobility_Index .

  4. Change from Baseline Rivermead Mobility Index results in four weeks after the rehabilitation procedures [ Time Frame: up to 6 weeks ]
    Dynamics according to the Rivermead Mobility Index (RMI) that assesses overall mobility in a range from 0 (worst score) to 15 (best score). Details available at https://www.physio-pedia.com/Rivermead_Mobility_Index .

  5. Change from Baseline Ashworth Spasticity Scale after the rehabilitation procedures [ Time Frame: 2 weeks ]
    Dynamics according to the Ashworth Spasticity Scale that assesses spasticity in a range from 0 (best score) to 4 (worst score). Details available at https://www.sralab.org/rehabilitation-measures/ashworth-scale- modified-ashworth-scale .https://www.sralab.org/rehabilitation-measures/ashworth-scale- modified-ashworth-scale

  6. Change from Baseline Ashworth Spasticity Scale in two four after the rehabilitation procedures [ Time Frame: up to 6 weeks ]
    Dynamics according to the Ashworth Spasticity Scale that assesses spasticity in a range from 0 (best score) to 4 (worst score). Details available at https://www.sralab.org/rehabilitation-measures/ashworth-scale- modified-ashworth-scale.

  7. Change from Baseline The Capabilities of Upper Extremity Test after the rehabilitation procedures [ Time Frame: 2 weeks ]
    Dynamics according to the Capabilities of the Upper Extremity Test (CUE-T). CUE-T is a performance measure intended to assess upper extremity function following spinal cord injury. Minimum is 0 (worst score), maximum unilateral (arm + hand) converted score is 60 (best for one hand). Derails available at https://www.jefferson.edu/university/rehabilitation-sciences/departments/outcomes-measurement/measures-assessments/capabilities-of-the-upper-extremity-test-cue-t.html

  8. Change from Baseline The Capabilities of Upper Extremity Test in four weeks after the rehabilitation procedures [ Time Frame: up to 6 weeks ]
    Dynamics according to the Capabilities of the Upper Extremity Test (CUE-T). CUE-T is a performance measure intended to assess upper extremity function following spinal cord injury. Minimum is 0 (worst score), maximum unilateral (arm + hand) converted score is 60 (best for one hand). Derails available at https://www.jefferson.edu/university/rehabilitation-sciences/departments/outcomes-measurement/measures-assessments/capabilities-of-the-upper-extremity-test-cue-t.html

  9. Change from Baseline Spinal Cord Independence Measure III after the rehabilitation procedures [ Time Frame: 2 weeks ]
    Dynamics according to the Spinal Cord Independence Measure III (SCIM III) that assesses a spinal cord injured patient's independence in a range from 0 (worst score) to 100 (best score). Details available at https://scireproject.com/wp- content/uploads/SCIM_Toolkit_Printable-1.pdf

  10. Change from Baseline Spinal Cord Independence Measure III in four weeks after the rehabilitation procedures [ Time Frame: up to 6 weeks ]
    Dynamics according to the Spinal Cord Independence Measure III (SCIM III) that assesses a spinal cord injured patient's independence in a range from 0 (worst score) to 100 (best score). Details available at https://scireproject.com/wp- content/uploads/SCIM_Toolkit_Printable-1.pdf

  11. Change from Baseline NIH Stroke Scale after the rehabilitation procedures [ Time Frame: 2 weeks ]
    Dynamics according to the National Institutes of Health Stroke Scale (NIHSS) that assesses a stroke patient's impairment in a range from 0 (best score) to 42 (worst score). Details available at https://www.nihstrokescale.org/ .

  12. Change from Baseline NIH Stroke Scale in four weeks after the rehabilitation procedures [ Time Frame: up to 6 weeks ]
    Dynamics according to the National Institutes of Health Stroke Scale (NIHSS) that assesses a stroke patient's impairment in a range from 0 (best score) to 42 (worst score). Details available at https://www.nihstrokescale.org/ .

  13. Change from Baseline American Spinal Injury Association Impairment Scale after the rehabilitation procedures [ Time Frame: 2 weeks ]
    Dynamics according to the American Spinal Injury Association Impairment Scale. The scale has five classification levels from Grade A (The impairment is complete) to Grade E (The patient's functions are normal). Details available at https://asia-spinalinjury.org/international-standards-neurological-classification-sci-isncsci-worksheet/

  14. Change from Baseline American Spinal Injury Association Impairment Scale in four weeks after the rehabilitation procedures [ Time Frame: up to 6 weeks ]
    Dynamics according to the American Spinal Injury Association Impairment Scale. The scale has five classification levels from Grade A (The impairment is complete) to Grade E (The patient's functions are normal). Details available at https://asia-spinalinjury.org/international-standards-neurological-classification-sci-isncsci-worksheet/

  15. Change from Baseline 36-Item Short Form Survey after the rehabilitation procedures [ Time Frame: 2 weeks ]

    The RAND 36-Item Health Survey taps eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. Each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively.

    Details available at https://www.rand.org/health-care/surveys_tools/mos/36-item-short-form.html


  16. Change from Baseline 36-Item Short Form Survey in four weeks after the rehabilitation procedures [ Time Frame: up to 6 weeks ]

    The RAND 36-Item Health Survey taps eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. Each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively.

    Details available at https://www.rand.org/health-care/surveys_tools/mos/36-item-short-form.html




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Criteria for inclusion in the study of patients:

  1. Signed written informed consent.
  2. Men or women aged 18 to 60 years after a first occurred acute cerebrovascular accident or in the recovery period after injury of the cervical and upper thoracic spinal cord.
  3. Early or late rehabilitation period of acute cerebrovascular accident by the type of ischemic stroke or the consequences of SCI in the late recovery period
  4. Diagnosis of "acute ischemic cerebrovascular accident", or a condition after spinal cord injury at the C3-C7 level, moderate or high severity ASIA A and ASIA B, according to the discharge summary, MRI or CT.
  5. For groups of patients with stroke: the degree of severity of paresis of the upper limb from 3 points to 0 (according to the 6-point MRC muscle strength scale https://cpd-program.ru/methods/mrc.htm)
  6. The patient's ability and willingness to comply with the requirements of this protocol.
  7. Expressed patient motivation for rehabilitation.

Inclusion criteria for healthy volunteers:

  1. Signed written informed consent.
  2. Men or women between the ages of 18 and 40
  3. Absence of somatic and psychiatric diseases (according to the reports of the subject and according to the examination of a medical specialist before the start of the study)
  4. Ability and willingness to comply with the requirements of this protocol.

Exclusion Criteria:

  1. Severe cognitive impairment (<10 points on the Montreal Cognitive Assessment Scale).
  2. The score on the Hamilton scale is above 18 points.
  3. The rating on the Rankin scale is higher than 4 points.
  4. Concomitant diseases that cause a decrease in muscle strength or an increase in muscle tone in the upper limbs (for example, cerebral palsy, brain damage as a result of trauma) or rigidity (for example, Parkinson's disease, contracture).
  5. Late stages of arthritis or significant limitation of range of motion.
  6. The absence of a part of the upper limb due to amputation caused by various reasons.
  7. Any medical condition, including mental illness or epilepsy, that may affect the interpretation of the test results, the conduct of the test, or the safety of the patient.
  8. Alcohol abuse, medical marijuana use, or light drug use in the previous 12 months.
  9. Use of experimental drugs or medical devices within the previous 30 days prior to Visit 1.
  10. Inability to comply with research procedures, according to the researcher.
  11. The severity of the patient's condition according to the data of the neurological or somatic status, which does not allow full rehabilitation
  12. Visual acuity less than 0.2 in the weakest eye according to the table of visual acuity of Sivtsev.
  13. Unstable angina and / or heart attack during the previous month
  14. History of stroke (for patients with spinal cord injury) or recurrent stroke (for patients with acute cerebrovascular accident).
  15. Uncontrolled arterial hypertension.
  16. Ataxia.
  17. Pacemaker and / or other implanted electronic devices.
  18. Taking muscle relaxants.
  19. Peripheral neuropathy.
  20. Concomitant diseases in the stage of exacerbation or decompensation, requiring active therapy.
  21. The presence of allergic reactions and / or other skin lesions at the place of application of the heart rate electrodes at the time of the study.
  22. Acute urinary tract infections.
  23. Acute thrombophlebitis.
  24. All forms of epilepsy.
  25. Benign and malignant neoplasms.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05115149


Contacts
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Contact: Natalya Podsosonnaya +7 (916) 670-39-18 N.Podsosonnaya@skoltech.ru
Contact: Daria Petrova +7 915 420 5113 d.petrova@skoltech.ru

Locations
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Russian Federation
Far Eastern Federal University Recruiting
Vladivostok, Primorsky Kray, Russian Federation, 690922
Contact: Ekaterina Mashtakova    007 (908) 462 82 71    mashtakova_ea@dvfu.ru   
Samara Regional Clinical Hospital Recruiting
Samara, Samarskaya Oblast, Russian Federation, 443095
Contact: Alexander Zakharov    007 (917) 162-03-01    alexander.zakharov1977@gmail.com   
Samara State Medical University Recruiting
Samara, Samarskaya Oblast, Russian Federation, 443099
Contact: Vasily Pyatin    007 (846) 374-10-04    v.f.pytin@samsmu.ru   
Kazansky Federal University Recruiting
Kazan, Tatarstan Republic, Russian Federation, 420008
Contact: Elvira Mukhametova    007 (819) 6867609    lviraqpg@gmail.com   
EirMED Rehabilitation Center Recruiting
Saint Petersburg, Russian Federation, 197136
Contact: Natalya Krutikova    007 (812) 566-06-97    krutikova1nb@gmail.com; info@eirmed.ru   
Pavlov Institute of Physiology Recruiting
Saint Petersburg, Russian Federation, 199034
Contact: Tatyana Moshonkina    007 (812) 328-11-0    moshonkina@infran.ru   
Sponsors and Collaborators
Skolkovo Institute of Science and Technology
Samara State Medical University
Samara Regional Clinical Hospital named after V.D. Seredavin
Kazan Federal University
Far Eastern Federal University
EirMED Rehabilitation Center
Pavlov Institute of Physiology, Russian Academy of Science
IT Universe LLC
VIBRAINT RUS LLC
Investigators
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Principal Investigator: Mikhail Lebedev, PhD Skolkovo Institute of Science and Technology (CNBR)
  Study Documents (Full-Text)

Documents provided by Skolkovo Institute of Science and Technology:
Informed Consent Form  [PDF] August 17, 2021

Publications:

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Responsible Party: Skolkovo Institute of Science and Technology
ClinicalTrials.gov Identifier: NCT05115149    
Other Study ID Numbers: Skoltech-CNBR1
First Posted: November 10, 2021    Key Record Dates
Last Update Posted: November 10, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Only selected research team members will have access to individual participant data. The research team will not be sharing or releasing any IPD to third parties.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Skolkovo Institute of Science and Technology:
Stroke
Transcutaneous spinal cord stimulation
tSCS
Brain-computer interface
BCI
Spinal Cord Injuries
Rehabilitation
Additional relevant MeSH terms:
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Spinal Cord Injuries
Central Nervous System Diseases
Nervous System Diseases
Spinal Cord Diseases
Trauma, Nervous System
Wounds and Injuries
Trans-sodium crocetinate
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Anticarcinogenic Agents
Antineoplastic Agents