Research on the Effectiveness of Neurorehabilitation After Stroke

Neurotechnika

Status: Enrolling

Conditions: Stroke, Acute, Ischemic; Stroke; Stroke with Hemiparesis; Stroke, Acute; Stroke Acute; Stroke, Ischemic

Treatments: Device: Neurorehabilitation simulator; Procedure: Standard course

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06753006

NT-STROKE-2024-09

Details and patient eligibility

About

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.

Enrollment: 44 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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 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 muscle tone 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 the study.
• 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 visual acuity 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 active treatment.
• Allergic reactions or other skin lesions at the EEG electrode application sites at the time of the study.
• Acute urinary tract infections.
• Acute thrombophlebitis.
• Any form of epilepsy.
• Benign and malignant neoplasms.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

44 participants in 4 patient groups

Control

Active Comparator group

Description:

The Control group receives a standard course of intervention (14-21 days) as prescribed by the attending physician, in accordance with the standards of the Ministry of Health of the Russian Federation for the provision of medical care to people who have suffered a stroke.

Treatment:

Procedure: Standard course

MI+VR

Experimental group

Description:

In addition to the standard course of intervention, the MI+VR group undergoes 10-12 sessions using a novel simulator involving the paretic arm with immersion in virtual reality.

Treatment:

Procedure: Standard course

Device: Neurorehabilitation simulator

MI2+VR

Experimental group

Description:

In addition to the standard course of intervention, the MI2+VR group undergoes 10-12 sessions using a novel simulator involving both arms (healthy and paretic) with immersion in virtual reality.

Treatment:

Procedure: Standard course

Device: Neurorehabilitation simulator

MI2

Experimental group

Description:

In addition to the standard course of intervention, the group MI2 undergoes 10-12 sessions using a novel simulator involving both arms (healthy and paretic) without immersion in virtual reality, using a computer display instead.

Treatment:

Procedure: Standard course

Device: Neurorehabilitation simulator