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

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.

Conditions

• Stroke
• Spinal Cord Injuries

Interventions

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.

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.

Sponsors & Collaborators

• Samara State Medical University

  collaborator OTHER

• Samara Regional Clinical Hospital V.D. Seredavin

  collaborator OTHER

• Kazan Federal University

  collaborator OTHER

• Far Eastern Federal University

  collaborator OTHER

• EirMED Rehabilitation Center

  collaborator UNKNOWN

• Pavlov Institute of Physiology, Russian Academy of Science

  collaborator UNKNOWN

• IT Universe LLC

  collaborator UNKNOWN

• VIBRAINT RUS LLC

  collaborator UNKNOWN

• Skolkovo Institute of Science and Technology

  lead OTHER

Principal Investigators

• Mikhail Lebedev, PhD · Skolkovo Institute of Science and Technology (CNBR)

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-10-01

Primary Completion

2022-12-20

Completion

2023-12-20

Countries

• Russia

Study Locations