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

NCT05115149 · Skolkovo Institute of Science and Technology · Updated 10 Nov 2021

What is being tested
VIBRAINT RehUp robotic orthosis; tSCS during the exercise; tSCS prior to the exercise; Neostim-5; Exercise
For
Stroke; Spinal Cord Injuries
Kind of study
Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
Who can join
Ages 18 years to 60 years. About 60 people. The full rules are on the registry page.
Where
Russia (6 sites)
When
Starts or started 1 Oct 2021, ends 20 Dec 2023. Registered 10 Nov 2021.
Results
None posted yet.

In the researchers' words

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.
ClinicalTrials.gov, NCT05115149

Sites

  • Far Eastern Federal UniversityVladivostok, Primorsky Kray, Russia
  • Samara Regional Clinical HospitalSamara, Samara Oblast, Russia
  • Samara State Medical UniversitySamara, Samara Oblast, Russia
  • Kazansky Federal UniversityKazan', Tatarstan Republic, Russia
  • EirMED Rehabilitation CenterSaint Petersburg, Russia
  • Pavlov Institute of PhysiologySaint Petersburg, Russia