StrokeNCT05115149
The Study of a Neural Interface and a Neurostimulation in the Rehabilitation of Upper Limb Movement Impairments.
A study testing VIBRAINT RehUp robotic orthosis, tSCS during the exercise and tSCS prior to the exercise in people with Stroke and Spinal Cord Injuries, run by Skolkovo Institute of Science and Technology at 6 sites in Russia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke, Spinal Cord Injuries
- What is being tested?
- VIBRAINT RehUp robotic orthosis, tSCS during the exercise and tSCS prior to the exercise
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 6 sitesRussia
- Study dates
- 1 Oct 2021to 20 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
- Ataxia.
- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Russia6 sites, 6 recruiting
- Recruiting
Kazansky Federal University
Kazan', Tatarstan Republic, 420008
Elvira Mukhametova, 007 (819) 6867609, lviraqpg@gmail.com
- Recruiting
EirMED Rehabilitation Center
Saint Petersburg, 197136
Natalya Krutikova, 007 (812) 566-06-97, krutikova1nb@gmail.com; info@eirmed.ru
- Recruiting
Pavlov Institute of Physiology
Saint Petersburg, 199034
Tatyana Moshonkina, 007 (812) 328-11-0, moshonkina@infran.ru
- Recruiting
Samara Regional Clinical Hospital
Samara, Samara Oblast, 443095
Alexander Zakharov, 007 (917) 162-03-01, alexander.zakharov1977@gmail.com
- Recruiting
Samara State Medical University
Samara, Samara Oblast, 443099
Vasily Pyatin, 007 (846) 374-10-04, v.f.pytin@samsmu.ru
- Recruiting
Far Eastern Federal University
Vladivostok, Primorsky Kray, 690922
Ekaterina Mashtakova, 007 (908) 462 82 71, mashtakova_ea@dvfu.ru
About this study
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.
Read the 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.
Biochemical monitoring will be applied for objective monitoring of the physiological conditions of patients, such as the physiological state of muscle tissue and the level of neuropathic pain. This method is based on the identification of metabolic and lipid compounds associated with physiological parameters in blood plasma samples, and the subsequent use of these compounds as biomarkers to assess the effectiveness of rehabilitation techniques carried out using the neural interface, as well as to optimize them. This monitoring will be helpful for each individual patient, as it will provide additional information about the course of rehabilitation. Blood sampling and follow-up testing will only be performed for patients who gave their written consent for this procedure. The analysis results will be stored in anonymized form.
The study participants will receive up to 12 rehabilitation procedures, each lasting about one hour, within two-four weeks. During the procedure, the activity of the brain (electroencephalogram) and muscles (electromyogram) will be recorded using non- invasive electrodes placed on the scalp and body. Also, during the study, electrical stimulation will be performed with non-invasive electrodes placed on the body.
During the exercise, participants focus their attention on the target of movement and/or imagine that their arms perform a movement. If the task is completed correctly, the robot will move the arm towards the target. This movement can additionally be accompanied with functional electrical stimulation using disposable electrodes glued to the skin on the back and/or the arms. The strength of the stimulation will be adjusted so as not to cause discomfort. Participants will be randomly assigned to groups, and participants in some groups will receive tSCS and some will not.
On the day of inclusion in the study, as part of Visit 1 (screening), anamnesis will be collected, and there will be performed assessment on the study scales, BCI testing, an EMG study with registration of muscle activity (rhomboid, pectoralis major, biceps, deltoid) and / or visual determination of tSCS thresholds.
After Visit 1, patients in the study groups will undergo 12 procedures of BCI-driven robotic rehabilitation accompanied by tSCS.
Visit 2 is carried out the next day after the end of the study to assess the study scales and conduct the EMG study described above.
Visit 3 is carried out one month after the end of the study to assess the study scales and conduct an EMG study.
Throughout the study, adverse events (AEs) will be monitored. Sessions will be held daily in 6/1 or 5/2 mode, in a rehabilitation room or at patients' homes, with a session duration of about 60 minutes. The duration of Visits 1-3 will be approximately 2 hours.
Investigators expect that a portion of the patients participating in the study will have an improvement in voluntary arm movements by the end of the study.
Patient data will be recorded and stored in anonymized form. Only research team members will have access to this information. If it is necessary to publish individual results on study scales, diagnoses, anamnesis, and age of participants, participants will be identified with codes. The study data is supposed to be stored for 10 years on a protected file storage with limited access.
- Conditions
- Stroke, Spinal Cord Injuries
- Being tested
- VIBRAINT RehUp robotic orthosis, tSCS during the exercise, tSCS prior to the exercise, Neostim-5, Exercise
- Keywords
- Stroke, Transcutaneous spinal cord stimulation, tSCS, Brain-computer interface, BCI, Spinal Cord Injuries, Rehabilitation
- Medical subject headings
- Stroke, Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VIBRAINT RehUp robotic orthosisDevice
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.
tSCS during the exerciseProcedure or surgery
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.
tSCS prior to the exerciseProcedure or surgery
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-5Device
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.
ExerciseProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Volga: tSCS during the exercise | Experimental | Stimulation during the excercise Receives: Device: VIBRAINT RehUp robotic orthosis; Procedure: tSCS during the exercise; Device: Neostim-5; Procedure: Exercise |
| Neva: tSCS prior to the exercise | Experimental | Stimulation prior to the action Receives: Device: VIBRAINT RehUp robotic orthosis; Procedure: tSCS prior to the exercise; Device: Neostim-5; Procedure: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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) .
Measured: 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) .
Measured: up to 6 weeks
Secondary outcomes (16)
Change from Baseline Accuracy of BCI tasks after the rehabilitation procedures
Dynamics of accuracy for BCI tasks (% of correctly completed tasks)
Measured: 2 weeks
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)
Measured: up to 6 weeks
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 .
Measured: 2 weeks
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 .
Measured: up to 6 weeks
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
Measured: 2 weeks
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.
Measured: up to 6 weeks
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
Measured: 2 weeks
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
Measured: up to 6 weeks
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
Measured: 2 weeks
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
Measured: up to 6 weeks
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/ .
Measured: 2 weeks
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/ .
Measured: up to 6 weeks
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/
Measured: 2 weeks
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/
Measured: up to 6 weeks
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
Measured: 2 weeks
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
Measured: up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2021
- Study start1 Oct 2021
- Primary completion20 Dec 2022 (estimated)
- Study completion20 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Skolkovo Institute of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Samara State Medical University, Samara Regional Clinical Hospital 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
- Responsible party
- Sponsor
- Investigators
- Mikhail Lebedev, PhD, Principal investigator, Skolkovo Institute of Science and Technology (CNBR)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05115149
- Sponsor's protocol ID
- Skoltech-CNBR1
- Status last verified
- Oct 2021
- First submitted
- 11 Oct 2021
- Last updated
- 10 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 27785645Hofstoetter 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.
PubMed 24042607Sayenko 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.
PubMed 30362876Pichiorri 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.
PubMed 25712802Lyukmanov 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.
PubMed 30251977Carvalho 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.
PubMed 30609208
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05115149
- Acronym / sponsor ID
- Skoltech-CNBR1
- Conditions
- Stroke, Spinal Cord Injuries
- Keywords
- Stroke, Transcutaneous spinal cord stimulation, tSCS, Brain-computer interface, BCI, Spinal Cord Injuries, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Skolkovo Institute of Science and TechnologyUniversity, hospital or other
- Collaborators
- Samara State Medical University, Samara Regional Clinical Hospital 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
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 20 Dec 2022 (estimated)
- Study completion
- 20 Dec 2023 (estimated)
- First posted
- 10 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Biochemical monitoring will be applied for objective monitoring of the physiological conditions of patients, such as the physiological state of muscle tissue and the level of neuropathic pain. This method is based on the identification of metabolic and lipid compounds associated with physiological parameters in blood plasma samples, and the subsequent use of these compounds as biomarkers to assess the effectiveness of rehabilitation techniques carried out using the neural interface, as well as to optimize them. This monitoring will be helpful for each individual patient, as it will provide additional information about the course of rehabilitation. Blood sampling and follow-up testing will only be performed for patients who gave their written consent for this procedure. The analysis results will be stored in anonymized form.
The study participants will receive up to 12 rehabilitation procedures, each lasting about one hour, within two-four weeks. During the procedure, the activity of the brain (electroencephalogram) and muscles (electromyogram) will be recorded using non- invasive electrodes placed on the scalp and body. Also, during the study, electrical stimulation will be performed with non-invasive electrodes placed on the body.
During the exercise, participants focus their attention on the target of movement and/or imagine that their arms perform a movement. If the task is completed correctly, the robot will move the arm towards the target. This movement can additionally be accompanied with functional electrical stimulation using disposable electrodes glued to the skin on the back and/or the arms. The strength of the stimulation will be adjusted so as not to cause discomfort. Participants will be randomly assigned to groups, and participants in some groups will receive tSCS and some will not.
On the day of inclusion in the study, as part of Visit 1 (screening), anamnesis will be collected, and there will be performed assessment on the study scales, BCI testing, an EMG study with registration of muscle activity (rhomboid, pectoralis major, biceps, deltoid) and / or visual determination of tSCS thresholds.
After Visit 1, patients in the study groups will undergo 12 procedures of BCI-driven robotic rehabilitation accompanied by tSCS.
Visit 2 is carried out the next day after the end of the study to assess the study scales and conduct the EMG study described above.
Visit 3 is carried out one month after the end of the study to assess the study scales and conduct an EMG study.
Throughout the study, adverse events (AEs) will be monitored. Sessions will be held daily in 6/1 or 5/2 mode, in a rehabilitation room or at patients' homes, with a session duration of about 60 minutes. The duration of Visits 1-3 will be approximately 2 hours.
Investigators expect that a portion of the patients participating in the study will have an improvement in voluntary arm movements by the end of the study.
Patient data will be recorded and stored in anonymized form. Only research team members will have access to this information. If it is necessary to publish individual results on study scales, diagnoses, anamnesis, and age of participants, participants will be identified with codes. The study data is supposed to be stored for 10 years on a protected file storage with limited access.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Volga: tSCS during the exercise | Experimental | Device: VIBRAINT RehUp robotic orthosis, Procedure: tSCS during the exercise, Device: Neostim-5, Procedure: ExerciseStimulation during the excercise |
| Neva: tSCS prior to the exercise | Experimental | Device: VIBRAINT RehUp robotic orthosis, Procedure: tSCS prior to the exercise, Device: Neostim-5, Procedure: ExerciseStimulation prior to the action |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (25 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VIBRAINT RehUp robotic orthosisVIBRAINT 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. | Device | Neva: tSCS prior to the exercise, Volga: tSCS during the exercise |
| tSCS during the exerciseDuring 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. | Procedure or surgery | Volga: tSCS during the exercise |
| tSCS prior to the exercisePrior 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. | Procedure or surgery | Neva: tSCS prior to the exercise |
| Neostim-5Neostim-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. | Device | Neva: tSCS prior to the exercise, Volga: tSCS during the exercise |
| ExerciseThe 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. | Procedure or surgery | Neva: tSCS prior to the exercise, Volga: tSCS during the exercise |
Primary outcome
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) .
16 secondary outcomes
Change from Baseline Accuracy of BCI tasks after the rehabilitation procedures
Time frame: 2 weeks
Change from Baseline in the Accuracy of BCI tasks in four weeks after the rehabilitation procedures
Time frame: up to 6 weeks
Change from Baseline Rivermead Mobility Index after the rehabilitation procedures
Time frame: 2 weeks
Change from Baseline Rivermead Mobility Index results in four weeks after the rehabilitation procedures
Time frame: up to 6 weeks
Change from Baseline Ashworth Spasticity Scale after the rehabilitation procedures
Time frame: 2 weeks
Change from Baseline Ashworth Spasticity Scale in two four after the rehabilitation procedures
Time frame: up to 6 weeks
Change from Baseline The Capabilities of Upper Extremity Test after the rehabilitation procedures
Time frame: 2 weeks
Change from Baseline The Capabilities of Upper Extremity Test in four weeks after the rehabilitation procedures
Time frame: up to 6 weeks
Change from Baseline Spinal Cord Independence Measure III after the rehabilitation procedures
Time frame: 2 weeks
Change from Baseline Spinal Cord Independence Measure III in four weeks after the rehabilitation procedures
Time frame: up to 6 weeks
Change from Baseline NIH Stroke Scale after the rehabilitation procedures
Time frame: 2 weeks
Change from Baseline NIH Stroke Scale in four weeks after the rehabilitation procedures
Time frame: up to 6 weeks
Change from Baseline American Spinal Injury Association Impairment Scale after the rehabilitation procedures
Time frame: 2 weeks
Change from Baseline American Spinal Injury Association Impairment Scale in four weeks after the rehabilitation procedures
Time frame: up to 6 weeks
Change from Baseline 36-Item Short Form Survey after the rehabilitation procedures
Time frame: 2 weeks
Change from Baseline 36-Item Short Form Survey in four weeks after the rehabilitation procedures
Time frame: up to 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2021.
- Background: PubMed 27785645Moshonkina 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.
- Background: PubMed 24042607Hofstoetter 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.
- Background: PubMed 30362876Sayenko 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.
- Background: PubMed 25712802Pichiorri 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.
- Background: PubMed 30251977Lyukmanov 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.
- Background: PubMed 30609208Carvalho 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.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mikhail Lebedev, PhD principal investigator
Skolkovo Institute of Science and Technology (CNBR)
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VIBRAINT RehUp robotic orthosis, tSCS during the exercise and tSCS prior to the exercise in people with Stroke and Spinal Cord Injuries, run by Skolkovo Institute of Science and Technology at 6 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Natalya Podsosonnaya (+7 (916) 670-39-18, N.Podsosonnaya@skoltech.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Fugl-Meyer scale for the upper limb after the rehabilitation procedures (time frame: 2 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05115149, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2021.