Stroke Clinical Trial
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.
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.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | December 20, 2023 |
Est. primary completion date | December 20, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Russian Federation | Kazansky Federal University | Kazan | Tatarstan Republic |
Russian Federation | EirMED Rehabilitation Center | Saint Petersburg | |
Russian Federation | Pavlov Institute of Physiology | Saint Petersburg | |
Russian Federation | Samara Regional Clinical Hospital | Samara | Samarskaya Oblast |
Russian Federation | Samara State Medical University | Samara | Samarskaya Oblast |
Russian Federation | Far Eastern Federal University | Vladivostok | Primorsky Kray |
Lead Sponsor | Collaborator |
---|---|
Skolkovo Institute of Science and Technology | EirMED Rehabilitation Center, Far Eastern Federal University, IT Universe LLC, Kazan Federal University, Pavlov Institute of Physiology, Russian Academy of Science, Samara Regional Clinical Hospital named after V.D. Seredavin, Samara State Medical University, VIBRAINT RUS LLC |
Russian Federation,
Carvalho R, Dias N, Cerqueira JJ. Brain-machine interface of upper limb recovery in stroke patients rehabilitation: A systematic review. Physiother Res Int. 2019 Apr;24(2):e1764. doi: 10.1002/pri.1764. Epub 2019 Jan 4. — View Citation
Hofstoetter US, Hofer C, Kern H, Danner SM, Mayr W, Dimitrijevic MR, Minassian K. Effects of transcutaneous spinal cord stimulation on voluntary locomotor activity in an incomplete spinal cord injured individual. Biomed Tech (Berl). 2013 Aug;58 Suppl 1. pii: /j/bmte.2013.58.issue-s1-A/bmt-2013-4014/bmt-2013-4014.xml. doi: 10.1515/bmt-2013-4014. Epub 2013 Sep 7. — View Citation
Lyukmanov RK, Aziatskaya GA, Mokienko OA, Varako NA, Kovyazina MS, Suponeva NA, Chernikova LA, Frolov AA, Piradov MA. [Post-stroke rehabilitation training with a brain-computer interface: a clinical and neuropsychological study]. Zh Nevrol Psikhiatr Im S S Korsakova. 2018;118(8):43-51. doi: 10.17116/jnevro201811808143. Russian. — View Citation
Moshonkina TR, Shapkova EY, Sukhotina IA, Emeljannikov DV, Gerasimenko YP. Effect of Combination of Non-Invasive Spinal Cord Electrical Stimulation and Serotonin Receptor Activation in Patients with Chronic Spinal Cord Lesion. Bull Exp Biol Med. 2016 Oct;161(6):749-754. Epub 2016 Oct 26. — View Citation
Pichiorri F, Morone G, Petti M, Toppi J, Pisotta I, Molinari M, Paolucci S, Inghilleri M, Astolfi L, Cincotti F, Mattia D. Brain-computer interface boosts motor imagery practice during stroke recovery. Ann Neurol. 2015 May;77(5):851-65. doi: 10.1002/ana.24390. Epub 2015 Mar 27. — View Citation
Sayenko DG, Rath M, Ferguson AR, Burdick JW, Havton LA, Edgerton VR, Gerasimenko YP. Self-Assisted Standing Enabled by Non-Invasive Spinal Stimulation after Spinal Cord Injury. J Neurotrauma. 2019 May 1;36(9):1435-1450. doi: 10.1089/neu.2018.5956. Epub 2018 Dec 15. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from Baseline Fugl-Meyer scale for the upper limb after the rehabilitation procedures | 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 weeks | |
Primary | Change from Baseline Fugl-Meyer scale for the upper limb in four weeks after the rehabilitation procedures | 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. | up to 6 weeks | |
Primary | Change from Baseline Action Research Arm Test after the rehabilitation procedures | 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) . | 2 weeks | |
Primary | Change from Baseline Action Research Arm Test in four weeks after the rehabilitation procedures | 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) . | up to 6 weeks | |
Secondary | Change from Baseline Accuracy of BCI tasks after the rehabilitation procedures | Dynamics of accuracy for BCI tasks (% of correctly completed tasks) | 2 weeks | |
Secondary | Change from Baseline in the Accuracy of BCI tasks in four weeks after the rehabilitation procedures | Dynamics of accuracy for BCI tasks (% of correctly completed tasks) | up to 6 weeks | |
Secondary | Change from Baseline Rivermead Mobility Index after the rehabilitation procedures | 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 . | 2 weeks | |
Secondary | Change from Baseline Rivermead Mobility Index results in four weeks after the rehabilitation procedures | 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 . | up to 6 weeks | |
Secondary | Change from Baseline Ashworth Spasticity Scale after the rehabilitation procedures | 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 | 2 weeks | |
Secondary | Change from Baseline Ashworth Spasticity Scale in two four after the rehabilitation procedures | 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. | up to 6 weeks | |
Secondary | Change from Baseline The Capabilities of Upper Extremity Test after the rehabilitation procedures | 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 | 2 weeks | |
Secondary | Change from Baseline The Capabilities of Upper Extremity Test in four weeks after the rehabilitation procedures | 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 | up to 6 weeks | |
Secondary | Change from Baseline Spinal Cord Independence Measure III after the rehabilitation procedures | 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 | 2 weeks | |
Secondary | Change from Baseline Spinal Cord Independence Measure III in four weeks after the rehabilitation procedures | 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 | up to 6 weeks | |
Secondary | Change from Baseline NIH Stroke Scale after the rehabilitation procedures | 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/ . | 2 weeks | |
Secondary | Change from Baseline NIH Stroke Scale in four weeks after the rehabilitation procedures | 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/ . | up to 6 weeks | |
Secondary | Change from Baseline American Spinal Injury Association Impairment Scale after the rehabilitation procedures | 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/ | 2 weeks | |
Secondary | Change from Baseline American Spinal Injury Association Impairment Scale in four weeks after the rehabilitation procedures | 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/ | up to 6 weeks | |
Secondary | Change from Baseline 36-Item Short Form Survey after the rehabilitation procedures | 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 |
2 weeks | |
Secondary | Change from Baseline 36-Item Short Form Survey in four weeks after the rehabilitation procedures | 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 |
up to 6 weeks |
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