The Study of a Neural Interface and a Neurostimulation in the Rehabilitation of Upper Limb Movement Impairments.
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.
1 other identifier
interventional
60
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable stroke
Started Oct 2021
Typical duration for not_applicable stroke
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2021
CompletedFirst Submitted
Initial submission to the registry
October 11, 2021
CompletedFirst Posted
Study publicly available on registry
November 10, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 20, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 20, 2023
CompletedNovember 10, 2021
October 1, 2021
1.2 years
October 11, 2021
October 29, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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
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
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
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 Outcomes (16)
Change from Baseline Accuracy of BCI tasks after the rehabilitation procedures
2 weeks
Change from Baseline in the Accuracy of BCI tasks in four weeks after the rehabilitation procedures
up to 6 weeks
Change from Baseline Rivermead Mobility Index after the rehabilitation procedures
2 weeks
Change from Baseline Rivermead Mobility Index results in four weeks after the rehabilitation procedures
up to 6 weeks
Change from Baseline Ashworth Spasticity Scale after the rehabilitation procedures
2 weeks
- +11 more secondary outcomes
Study Arms (2)
Volga: tSCS during the exercise
EXPERIMENTALStimulation during the excercise
Neva: tSCS prior to the exercise
EXPERIMENTALStimulation prior to the action
Interventions
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.
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.
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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 1.
- 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.
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Skolkovo Institute of Science and Technologylead
- Samara State Medical Universitycollaborator
- Samara Regional Clinical Hospital V.D. Seredavincollaborator
- Kazan Federal Universitycollaborator
- Far Eastern Federal Universitycollaborator
- EirMED Rehabilitation Centercollaborator
- Pavlov Institute of Physiology, Russian Academy of Sciencecollaborator
- IT Universe LLCcollaborator
- VIBRAINT RUS LLCcollaborator
Study Sites (6)
Far Eastern Federal University
Vladivostok, Primorsky Kray, 690922, Russia
Samara Regional Clinical Hospital
Samara, Samara Oblast, 443095, Russia
Samara State Medical University
Samara, Samara Oblast, 443099, Russia
Kazansky Federal University
Kazan', Tatarstan Republic, 420008, Russia
EirMED Rehabilitation Center
Saint Petersburg, 197136, Russia
Pavlov Institute of Physiology
Saint Petersburg, 199034, Russia
Related Publications (6)
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. doi: 10.1007/s10517-016-3501-4. Epub 2016 Oct 26.
PMID: 27785645BACKGROUNDHofstoetter 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:/j/bmte.2013.58.issue-s1-A/bmt-2013-4014/bmt-2013-4014.xml. doi: 10.1515/bmt-2013-4014. Epub 2013 Sep 7. No abstract available.
PMID: 24042607BACKGROUNDSayenko 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.
PMID: 30362876BACKGROUNDPichiorri 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.
PMID: 25712802BACKGROUNDLyukmanov 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.
PMID: 30251977BACKGROUNDCarvalho 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.
PMID: 30609208BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mikhail Lebedev, PhD
Skolkovo Institute of Science and Technology (CNBR)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Masking Details
- 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
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 11, 2021
First Posted
November 10, 2021
Study Start
October 1, 2021
Primary Completion
December 20, 2022
Study Completion
December 20, 2023
Last Updated
November 10, 2021
Record last verified: 2021-10
Data Sharing
- IPD Sharing
- Will not share
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.