Research on the Effectiveness of Neurorehabilitation After Stroke

Last updated: December 31, 2024
Sponsor: Neurotechnika
Overall Status: Active - Recruiting

Phase

N/A

Condition

Stroke

Occlusions

Blood Clots

Treatment

Neurorehabilitation simulator

Standard course

Clinical Study ID

NCT06753006
NT-STROKE-2024-09
  • Ages 18-80
  • All Genders

Study Summary

This clinical trial aims to investigate the effectiveness of a novel neurorehabilitation technology for treating stroke in adults. The study will evaluate a simulator that combines robotic orthosis, a non-invasive brain-computer interface (BCI), and a virtual reality (VR) display. The goal of this trial is to advance stroke rehabilitation by exploring the potential benefits of these cutting-edge technologies.

Key Research Questions:

Efficacy: Does the new simulator significantly improve arm function compared to standard rehabilitation techniques?

BCI Technology: Which approach - motor imagery of only the paretic arm or both the paretic and healthy arm - yields greater functional improvements?

VR Contribution: How does the integration of VR enhance rehabilitation outcomes?

Safety and Tolerability: What potential side effects or adverse events may arise from using the new simulator?

Participants who have suffered a stroke will undergo a standard rehabilitation course, during which 10-12 sessions will take place using the innovative simulator: a robotic device moves a patient's paralyzed arm at the command of a non-invasive brain-computer interface to perform a game task resembling real-life activities, augmented by a virtual reality display.

Researchers will assess the impact of the new technology on arm function to determine its efficacy in promoting recovery.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Signed written informed consent.

  • Age 18 to 80 years at the time of stroke onset.

  • Early rehabilitation period (up to 6 months post-stroke).

  • Diagnosis of acute cerebrovascular accident confirmed by MRI or CT.

  • Upper limb paresis severity between 0 and 3 on the 6-point Medical Research Council (MRC) muscle strength scale.

  • Ability and willingness to comply with the study protocol.

  • Demonstrated motivation for rehabilitation.

Exclusion

Exclusion Criteria:

  • Montreal Cognitive Assessment scale (MoCA) score less than 10 points.

  • Hamilton Depression Rating Scale (Ham-D) score greater than 18 points.

  • Modified Rankin Scale (mRS) score greater than 4 points.

  • Pre-existing conditions that cause decreased muscle strength or increased muscletone in the upper limbs (e.g., cerebral palsy, traumatic brain injury) or rigidity (e.g., Parkinson's disease, contractures).

  • Advanced arthritis or significant limitation of upper limb range of motion.

  • Absence of part of the upper limb due to amputation for any reason.

  • Any medical condition that may affect the conduct of the study or patient safety (e.g., mental illness).

  • Alcohol abuse or recreational drug use within the 12 months preceding the study.

  • Use of experimental medications or medical devices within the 30 days preceding thestudy.

  • Inability to comply with research procedures, as determined by the researcher.

  • The severity of the patient's condition, based on neurological or physical status,does not permit full rehabilitation.

  • Visual acuity less than 0.2 in the weakest eye according to the Sivtsev visualacuity chart.

  • Unstable angina and/or heart attack within the 30 days preceding the study.

  • Recurrent stroke.

  • Uncontrolled arterial hypertension.

  • Ataxia.

  • Presence of a pacemaker and/or other implanted electronic devices.

  • Use of muscle relaxants.

  • Peripheral neuropathy.

  • Coexisting diseases in an exacerbation or decompensated stage requiring activetreatment.

  • Allergic reactions or other skin lesions at the EEG electrode application sites atthe time of the study.

  • Acute urinary tract infections.

  • Acute thrombophlebitis.

  • Any form of epilepsy.

  • Benign and malignant neoplasms.

Study Design

Total Participants: 44
Treatment Group(s): 2
Primary Treatment: Neurorehabilitation simulator
Phase:
Study Start date:
August 27, 2024
Estimated Completion Date:
July 31, 2025

Connect with a study center

  • Samara Regional Clinical Hospital named after V.D. Seredavin

    Samara, Samara Region 443095
    Russian Federation

    Active - Recruiting

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