Clinical trial NCT06753006: Research on the Effectiveness of Neurorehabilitation After Stroke
Official title: A Study of Neurorehabilitation Based on Robotics, Brain-Computer Interface (BCI) and Virtual Reality (VR) in Patients with Upper Limb Paresis Due to Stroke in the Early Rehabilitation Period
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Stroke Acute
Stroke with Hemiparesis
Stroke, Acute
Stroke, Acute, Ischemic
Stroke, Ischemic
Keywords: Stroke
Rehabilitation
Brain-Computer Interface
Motor Imagery
Robotics
Virtual Reality
Neurofeedback
Lead sponsor: Neurotechnika
Sponsor class: INDUSTRY
Collaborators: name: Samara State Medical University
name: Samara Regional Clinical Hospital V.D. Seredavin
First posted: 2024-12-31
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assigned to either one of three experimental groups or a control group.
Primary purpose: TREATMENT

Brief 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 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.

Primary outcomes:
measure: FMA-UE A-D
timeFrame: From enrollment to the end of treatment at 2-3 weeks
measure: ARAT
timeFrame: From enrollment to the end of treatment at 2-3 weeks
Secondary outcomes:
measure: NIHSS
timeFrame: From enrollment to the end of treatment at 2-3 weeks
measure: Ashworth
timeFrame: From enrollment to the end of treatment at 2-3 weeks
measure: RMI
timeFrame: From enrollment to the end of treatment at 2-3 weeks
measure: MRS
timeFrame: From enrollment to the end of treatment at 2-3 weeks
measure: SF-36
timeFrame: From enrollment to the end of treatment at 2-3 weeks
Other outcomes:
measure: ICF
timeFrame: From enrollment to the end of treatment at 2-3 weeks
Locations:
city: Samara
country: Russian Federation
facility: Samara Regional Clinical Hospital named after V.D. Seredavin
state: Samara Region
Study officials:
affiliation: Samara State Medical University
name: Alexander Zakharov, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: