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.
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 60
- Locations
- 12
- Primary Endpoint
- Change from Baseline Fugl-Meyer scale for the upper limb after the rehabilitation procedures
Study Overview
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.
Detailed Description
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 in virtual reality (for example, aiming a hand-held virtual toy gun at a target), as well as an electrical stimulation device that activates the spinal cord and/or muscles of the paralyzed arm.
The study is carried out to collect data on the role of central and spinal mechanisms in the plasticity of neuronal circuits that determine the effect of combined spinal neurostimulation and robotic rehabilitation under the control of non-invasive neural interfaces in patients in early and late rehabilitation period after acute cerebrovascular accident and in patients after trauma of the cervical and upper thoracic spinal cord.
The study will use two technologies - neural interfaces and transcutaneous electrical stimulation of the spinal cord. Neural interfaces are a rapidly developing area at the intersection of medicine, neuroscience, biology, engineering, robotics, physics, mathematics, and materials science, which aims to reproduce and supplement brain functions and correct these functions in cases of neurological lesions. The possibility of using neural interfaces for the treatment of neurological disorders, including disorders resulting from spinal cord and brain injuries, epilepsy, strokes, and neurodegenerative diseases, such as Parkinson's disease, has been demonstrated.
Transcutaneous spinal cord stimulation (tSCS) is a method for non-invasive control of the activity of human spinal neural networks used to restore locomotor functions after spinal cord injury (SCI). The published research results show that tSCS modulates the activity of not only spinal but also cortical neuronal networks.
It is expected that the use of tSCS in conjunction with the use of neural interfaces will increase the effectiveness of neural interfaces for the rehabilitation of neurological lesions, including stroke, and SCI.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- 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
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Criteria for inclusion in the study of patients:
- •Signed written informed consent.
- •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.
- •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
- •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.
- •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)
- •The patient's ability and willingness to comply with the requirements of this protocol.
- •Expressed patient motivation for rehabilitation.
- •Inclusion criteria for healthy volunteers:
- •Signed written informed consent.
- •Men or women between the ages of 18 and 40
- •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)
- •Ability and willingness to comply with the requirements of this protocol.
Exclusion Criteria
- •Severe cognitive impairment (<10 points on the Montreal Cognitive Assessment Scale).
- •The score on the Hamilton scale is above 18 points.
- •The rating on the Rankin scale is higher than 4 points.
- •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).
- •Late stages of arthritis or significant limitation of range of motion.
- •The absence of a part of the upper limb due to amputation caused by various reasons.
- •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.
- •Alcohol abuse, medical marijuana use, or light drug use in the previous 12 months.
- •Use of experimental drugs or medical devices within the previous 30 days prior to Visit
- •Inability to comply with research procedures, according to the researcher.
- •The severity of the patient's condition according to the data of the neurological or somatic status, which does not allow full rehabilitation
- •Visual acuity less than 0.2 in the weakest eye according to the table of visual acuity of Sivtsev.
- •Unstable angina and / or heart attack during the previous month
- •History of stroke (for patients with spinal cord injury) or recurrent stroke (for patients with acute cerebrovascular accident).
- •Uncontrolled arterial hypertension.
- •Pacemaker and / or other implanted electronic devices.
- •Taking muscle relaxants.
- •Peripheral neuropathy.
- •Concomitant diseases in the stage of exacerbation or decompensation, requiring active therapy.
- •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.
- •Acute urinary tract infections.
- •Acute thrombophlebitis.
- •All forms of epilepsy.
- •Benign and malignant neoplasms.
Outcomes
Primary Outcomes
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.
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.
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) .
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 Outcomes
- Change from Baseline Accuracy of BCI tasks after the rehabilitation procedures(2 weeks)
- Change from Baseline Rivermead Mobility Index after the rehabilitation procedures(2 weeks)
- Change from Baseline The Capabilities of Upper Extremity Test in four weeks after the rehabilitation procedures(up to 6 weeks)
- Change from Baseline The Capabilities of Upper Extremity Test after the rehabilitation procedures(2 weeks)
- Change from Baseline NIH Stroke Scale in four weeks after the rehabilitation procedures(up to 6 weeks)
- Change from Baseline in the Accuracy of BCI tasks in four weeks after the rehabilitation procedures(up to 6 weeks)
- Change from Baseline Ashworth Spasticity Scale after the rehabilitation procedures(2 weeks)
- Change from Baseline Ashworth Spasticity Scale in two four after the rehabilitation procedures(up to 6 weeks)
- Change from Baseline Rivermead Mobility Index results in four weeks after the rehabilitation procedures(up to 6 weeks)
- Change from Baseline Spinal Cord Independence Measure III after the rehabilitation procedures(2 weeks)
- Change from Baseline American Spinal Injury Association Impairment Scale after the rehabilitation procedures(2 weeks)
- Change from Baseline American Spinal Injury Association Impairment Scale in four weeks after the rehabilitation procedures(up to 6 weeks)
- Change from Baseline Spinal Cord Independence Measure III in four weeks after the rehabilitation procedures(up to 6 weeks)
- Change from Baseline NIH Stroke Scale after the rehabilitation procedures(2 weeks)
- Change from Baseline 36-Item Short Form Survey in four weeks after the rehabilitation procedures(up to 6 weeks)
- Change from Baseline 36-Item Short Form Survey after the rehabilitation procedures(2 weeks)