StrokeNCT06806397
Study of Hemodynamic Markers of Upper Extremity Motor Dysfunction in Stroke Patients Using Functional Near Infrared Spectroscopy (fNIRS)
An observational study of Stroke and Stroke with Hemiparesis, run by Skolkovo Institute of Science and Technology at 2 sites in Russia.
Trial summary
The aim of the study was to explore potential pathways for recovery and adaptation of the motor cortex by examining cerebral blood flow characteristics and hemodynamic markers analyzed by functional near-infrared spectroscopy (fNIRS) in patients with hemiparesis after stroke. Read more about this study
- Who is it for?
- Ages 35 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke, Stroke with Hemiparesis, Stroke, Ischemic
- What is being tested?
- Stimulus response task
- How many people
- 40 participants
- Where
- 2 sitesRussia
- Study dates
- 26 Jun 2024to Apr 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients undergoing rehabilitation at the Federal center of brain research and neurotechnologies, FMBA, Moscow, Russia
Who may be able to join
- 1. Availability of signed written informed consent. 3. Absence of somatic and psychiatric diseases (more details in the exclusion criteria) 4. Ability and willingness to comply with the requirements of this protocol.
- Signed written informed consent.
- People after the first acute cerebrovascular accident (CVA), early or late rehabilitation period.
- The level of severity of paresis of the upper limb from 3 points to 0 (according to a 6-point neurological scale)
- The minimum visual acuity is not lower than 0.2 on the Sivtsev scale.
- The ability and willingness of the patient to comply with the requirements of this protocol.
- Expressed patient motivation for rehabilitation.
Who cannot join
- The presence of superficial injury of head (S00-S09 International Classification of Diseases 10 (ICD-10).
- The presence of mental, behavioural disorders (F00-F99 ICD-10).
- Drug addiction in the past or at the moment.
- The presence of diseases of the nervous system (G00-G99 ICD-10).
- . History of intracranial injury (S06 ICD-10) or stroke (I64 ICD-10).
- The presence of somatoform disorders (F45 ICD-10).
Show all 29Show fewer
- Any conditions that, in the opinion of the Investigator, meet the exclusion criteria
- Presence of electrical and/or metallic implants or stimulants in the body (eg, implanted deep brain stimulation devices, pacemakers, hearing aids and cochlear implants, intracranial metal implants).
- Pregnancy
- The presence of malignant neoplasms (C00-C97 ICD-10).
- For stroke patients:
- Severe cognitive impairment (<10 points according to the Montreal Cognitive Assessment Scale).
- Hamilton score above 18 points.
- The score on the Rankin scale is above 4 points.
- Associated neurological disorders that cause decreased muscle strength or increased muscle tone in the upper limbs (eg, cerebral palsy, brain damage from trauma) or stiffness (eg, Parkinson's disease, contracture).
- Late stages of arthritis or clinically significant limitation of passive range of motion in any of the joints studied in the study due to other reasons.
- The absence of a part of the upper limb due to amputation caused by various reasons.
- Any medical condition, including mental illness or epilepsy, that may affect the interpretation of study results, study conduct, or patient safety.
- Alcohol abuse, medical marijuana use, or recreational drug use in the 12 months prior to Visit 1.
- Use of experimental drugs or medical devices within 30 days prior to Visit 1.
- Lack of ability to follow study procedures, in the opinion of the investigator.
- The severity of the patient's condition according to the neurological or somatic status, which does not allow full rehabilitation.
- Severe visual disturbances, minimal visual acuity less than 0.2 Sivtsev visual acuity table.
- Unstable angina and/or heart attack within the previous month
- Repeated stroke.
- Severe unilateral spatial neglect.
- Uncontrolled arterial hypertension
- Ataxia
- All forms of epilepsy
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Russia2 sites, 1 recruiting
- Completed
Skolkovo Institute of Science and Technology (Skoltech)
Moscow
- Recruiting
Skolkovo Institute of Science and Technology (Skoltech)
Moscow
About this study
Official title: Studying the Mechanisms of Visual-motor Transformation to Find Neurophysiological Markers of Altered Functions of Cortical Motor Circuits in Patients with Neurological Disorders and Developing Technologies for Their Rehabilitation.
The aim of the study was to explore potential pathways for recovery and adaptation of the motor cortex by examining cerebral blood flow characteristics and hemodynamic markers analyzed by functional near-infrared spectroscopy (fNIRS) in patients with hemiparesis after stroke. Participants in the study performed a simple stimulus-response task several times with one healthy and one paralyzed limb at different stages of basic rehabilitation. A group of healthy, age-matched volunteers participated in the same experiment to verify the stroke-related changes. The researchers recorded fNIRS signals, muscle activity using electromyography, and heart activity using electrocardiography.
Read the detailed description
The study included 40 participants, divided into two groups: individuals with a history of stroke-related hemiparesis and a matched healthy control group.Participants were instructed to perform a stimulus-response task designed to assess reaction speed.During the task, they positioned their hands within a designated box equipped with two buttons corresponding to left and right responses. A visual stimulus, presented via LEDs located above the buttons, served as the response target. A flash of a stimulus required participants to respond by extending their fingers to press the corresponding button. If limb paresis prevented a full button press, participants were instructed to form an intention to move and attempt the task to the best of their ability.
Neurophysiological data acquisition. Functional near-infrared spectroscopy (fNIRS) data were acquired using a combined NIRSport 16x16 and NIRSport 8x8 system (NIRx Medizintechnik GmbH, Berlin, Germany).Twenty-four sources and 24 detectors were placed over the sensorimotor area and adjacent regions, forming 76 source-detector pairs to ensure comprehensive cortical coverage. The light sources were activated synchronously, resulting in a sampling rate of 13.56 Hz. In addition, surface electromyography (EMG), electrocardiography (ECG), and scalp electroencephalography (EEG) were recorded using the NVX-36 electroencephalograph (ISS, Zelenograd, Russia). EMG activity was recorded from the extensor digitorum communis muscle of both hands using a bipolar belly-tendon montage. ECG was recorded by 1st standard bipolar montage with electrode placed on both wrists. EEG was recorded with 6 electrodes placed at 'FCC3', 'FCC4', 'CCP3', 'CCP4', 'FCC5', 'A1', 'FCC6', 'A2' according to the standard "10-05" montage. The experimental protocol was completed within two weeks for each participant. There were six sessions (3 at the beginning of rehabilitation and 3 before discharge). Each session lasted a maximum of one hour. Before the experimental session, each patient's motor abilities were tested using the Action Research Arm Test (ARAT) and the Fugl-Meyer Assessment (FMA) scale.
- Conditions
- Stroke, Stroke with Hemiparesis, Stroke, Ischemic
- Being tested
- Stimulus response task
- Keywords
- stroke, hemiparesis, hemodynamics, fNIRS, restoration of motor function, Neurovascular coupling
- Medical subject headings
- Stroke, Ischemic Stroke, Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stimulus response taskDiagnostic test
Participants were tasked with performing a finger extension exercise that required pressing buttons in response to visual stimuli. In cases where physical movement was not possible, participants were instructed to imagine performing the task while focusing on their fingers.
| Study group | Role | What they receive |
|---|---|---|
| Individuals after stroke | Not described Receives: Diagnostic Test: Stimulus response task | |
| Healthy volunteers | Not described Receives: Diagnostic Test: Stimulus response task |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemodynamic changes after stroke
In post-stroke subjects, an increase in blood flow and oxygenation was observed in sensorimotor cortical regions of both hemispheres during movement of the paretic limb. This observation may indicate that the healthy hemisphere contributes to the execution of movement.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2025
- Study start26 Jun 2024
- Primary completion20 Jan 2025
- Study completionApr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Skolkovo Institute of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Federal Center of Brain Research and Neurotechnologies of the Federal Medical Biological Agency of Russia
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06806397
- Sponsor's protocol ID
- Skoltech-CNBR7
- Other IDs
- 21-75-30024
- Status last verified
- Jan 2025
- First submitted
- 28 Jan 2025
- Last updated
- 4 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Studying the Mechanisms of Visual-motor Transformation to Find Neurophysiological Markers of Altered Functions of Cortical Motor Circuits in Patients with Neurological Disorders and Developing Technologies for Their Rehabilitation.
- ClinicalTrials.gov ID
- NCT06806397
- Acronym / sponsor ID
- Skoltech-CNBR7
- Conditions
- Stroke, Stroke with Hemiparesis, Stroke, Ischemic
- Keywords
- stroke, hemiparesis, hemodynamics, fNIRS, restoration of motor function, Neurovascular coupling
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Skolkovo Institute of Science and TechnologyUniversity, hospital or other
- Collaborators
- Federal Center of Brain Research and Neurotechnologies of the Federal Medical Biological Agency of Russia
- Study start
- 26 Jun 2024 (actual)
- Primary completion
- 20 Jan 2025 (actual)
- Study completion
- Apr 2025 (estimated)
- First posted
- 4 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study was to explore potential pathways for recovery and adaptation of the motor cortex by examining cerebral blood flow characteristics and hemodynamic markers analyzed by functional near-infrared spectroscopy (fNIRS) in patients with hemiparesis after stroke. Participants in the study performed a simple stimulus-response task several times with one healthy and one paralyzed limb at different stages of basic rehabilitation. A group of healthy, age-matched volunteers participated in the same experiment to verify the stroke-related changes. The researchers recorded fNIRS signals, muscle activity using electromyography, and heart activity using electrocardiography.
Detailed description
The study included 40 participants, divided into two groups: individuals with a history of stroke-related hemiparesis and a matched healthy control group.Participants were instructed to perform a stimulus-response task designed to assess reaction speed.During the task, they positioned their hands within a designated box equipped with two buttons corresponding to left and right responses. A visual stimulus, presented via LEDs located above the buttons, served as the response target. A flash of a stimulus required participants to respond by extending their fingers to press the corresponding button. If limb paresis prevented a full button press, participants were instructed to form an intention to move and attempt the task to the best of their ability.
Neurophysiological data acquisition. Functional near-infrared spectroscopy (fNIRS) data were acquired using a combined NIRSport 16x16 and NIRSport 8x8 system (NIRx Medizintechnik GmbH, Berlin, Germany).Twenty-four sources and 24 detectors were placed over the sensorimotor area and adjacent regions, forming 76 source-detector pairs to ensure comprehensive cortical coverage. The light sources were activated synchronously, resulting in a sampling rate of 13.56 Hz. In addition, surface electromyography (EMG), electrocardiography (ECG), and scalp electroencephalography (EEG) were recorded using the NVX-36 electroencephalograph (ISS, Zelenograd, Russia). EMG activity was recorded from the extensor digitorum communis muscle of both hands using a bipolar belly-tendon montage. ECG was recorded by 1st standard bipolar montage with electrode placed on both wrists. EEG was recorded with 6 electrodes placed at 'FCC3', 'FCC4', 'CCP3', 'CCP4', 'FCC5', 'A1', 'FCC6', 'A2' according to the standard "10-05" montage. The experimental protocol was completed within two weeks for each participant. There were six sessions (3 at the beginning of rehabilitation and 3 before discharge). Each session lasted a maximum of one hour. Before the experimental session, each patient's motor abilities were tested using the Action Research Arm Test (ARAT) and the Fugl-Meyer Assessment (FMA) scale.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Individuals after stroke | – | Diagnostic Test: Stimulus response task |
| Healthy volunteers | – | Diagnostic Test: Stimulus response task |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing rehabilitation at the Federal center of brain research and neurotechnologies, FMBA, Moscow, Russia
Key inclusion criteria (7 listed)
- 1. Availability of signed written informed consent. 3. Absence of somatic and psychiatric diseases (more details in the exclusion criteria) 4. Ability and willingness to comply with the requirements of this protocol.
- Signed written informed consent.
- People after the first acute cerebrovascular accident (CVA), early or late rehabilitation period.
- The level of severity of paresis of the upper limb from 3 points to 0 (according to a 6-point neurological scale)
- The minimum visual acuity is not lower than 0.2 on the Sivtsev scale.
Key exclusion criteria (29 listed)
- The presence of superficial injury of head (S00-S09 International Classification of Diseases 10 (ICD-10).
- The presence of mental, behavioural disorders (F00-F99 ICD-10).
- Drug addiction in the past or at the moment.
- The presence of diseases of the nervous system (G00-G99 ICD-10).
- . History of intracranial injury (S06 ICD-10) or stroke (I64 ICD-10).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stimulus response taskParticipants were tasked with performing a finger extension exercise that required pressing buttons in response to visual stimuli. In cases where physical movement was not possible, participants were instructed to imagine performing the task while focusing on their fingers. | Diagnostic test | Healthy volunteers, Individuals after stroke |
Primary outcome
Hemodynamic changes after stroke
Time frame: 14 days
In post-stroke subjects, an increase in blood flow and oxygenation was observed in sensorimotor cortical regions of both hemispheres during movement of the paretic limb. This observation may indicate that the healthy hemisphere contributes to the execution of movement.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Stroke with Hemiparesis, run by Skolkovo Institute of Science and Technology at 2 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daria Petrova, PhD (+7 915 420 5113, d.petrova@skoltech.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemodynamic changes after stroke (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2025.