NCT06753006Recruiting
Research on the Effectiveness of Neurorehabilitation After Stroke
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
Source: ClinicalTrials.gov · Last updated 1 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 44 (estimated)
- First submitted
- 21 Dec 2024
- Start date
- 27 Aug 2024
- Primary completion date
- Jul 2025
- Lead sponsor
- Neurotechnika
- Diseases
- Stroke
- NCT number
- NCT06753006
What you commit to
- Study type: Interventional
- Planned participants: 44
- From 27 Aug 2024 to the primary completion date, Jul 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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).
- Any medical condition that may affect the conduct of the study or patient safety (e.g., mental illness).
- The severity of the patient's condition, based on neurological or physical status, does not permit full rehabilitation.
- Unstable angina and/or heart attack within the 30 days preceding the study.
- Recurrent stroke.
- Uncontrolled arterial hypertension.
- 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.
- Any form of epilepsy.
- Benign and malignant neoplasms.
Other
- 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.
- Advanced arthritis or significant limitation of upper limb range of motion.
- Absence of part of the upper limb due to amputation for any reason.
- Inability to comply with research procedures, as determined by the researcher.
- Visual acuity less than 0.2 in the weakest eye according to the Sivtsev visual acuity chart.
- Ataxia.
- Presence of a pacemaker and/or other implanted electronic devices.
- Use of muscle relaxants.
- Peripheral neuropathy.
- Acute thrombophlebitis.
Who the study is looking for
- 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.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Samara Regional Clinical Hospital named after V.D. Seredavin Coordinator of this site? Confirm its status | Samara | Russia | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.