Ignite Creation Date:
2025-12-25 @ 5:07 AM
Ignite Modification Date:
2026-02-25 @ 5:51 PM
Study NCT ID:
NCT06386627
Status:
COMPLETED
Last Update Posted:
2024-05-23
First Post:
2024-04-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Neurophysiological Markers of Motor Recovery in Post-stroke Patients.
Sponsor:
Skolkovo Institute of Science and Technology
Organization:
Study Overview
Official Title:
Study of the Mechanisms of Visual-motor Transformation to Search for Neurophysiological Markers of Changes in the Functions of Cortical Motor Circuits in Patients With Neurological Disorders, and Development of Technologies for Their Rehabilitation.
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of the study was to explore potential pathways for recovery and adaptation of neural pathways after stroke by examining electrical activity of the brain cortex and cortico-spinal excitability using transcranial magnetic stimulation in people with motor impairment after stroke. Participants in the study performed a simple stimulus-response task with a healthy and a paralysed limb several times at different stages of basic rehabilitation. To compare the data, a group of healthy volunteers took part in a similar experiment. Investigators recorded cortical activity using electroencephalography and muscle activity using electromyography. After the stimulus-response task, investigators also carried out a study using transcranial magnetic stimulation to assess the integrity of corticospinal connections.
Detailed Description:
The study involved 40 participants, half of whom had suffered a stroke with hemiparesis and the other half a control group of healthy volunteers. During the experimental session, the participants have to perform a motor task involving reaction speed. A box with two buttons (right and left) is placed in front of the participant. The participant's hands are placed in the box under the buttons. The experimental task is to press one of the two buttons by extending the fingers in response to a visual stimulus - lamps above the buttons. If the degree of damage to the motor function of one of the participant's limbs does not allow a full button to be pressed, the participants is asked to form an intention for this movement and try to perform it. At the same time, one of the buttons has been designated as a 'target' for the patient, and it is in response to its highlighting that a movement is to be performed. The second button is 'non-target'. Its highlighting should be ignored. Throughout the session, each of the buttons was designated as a target several times.
Throughout the session, the electroencephalogram (EEG) signal was recorded in 17 electrodes placed on the scalp according to the international "10-10" registration system. The recording was performed with a medical electroencephalograph NVX-36 ("Medical Computer Systems", Zelenograd, Russia). Electromyographic (EMG) activity of the flexor digitorum superficialis muscles of both hands was also recorded using surface electrodes. The EMG is recorded with the same amplifier as the EEG signal (NVX-36). The participant takes part in the test within 2 weeks. There were two sessions (at the beginning of rehabilitation and before discharge). Each session lasts a maximum of one hour.
Before the study, the participants' motor activity was tested using the Action Research Arm Test (ARAT). The EEG data were analysed for markers such as movement-related potentials and movement-related desynchronisation of alpha and beta rhythms. Some participants were also invited to take part in an additional study using transcranial magnetic stimulation to assess the integrity of corticospinal connections.
Throughout the session, the electroencephalogram (EEG) signal was recorded in 17 electrodes placed on the scalp according to the international "10-10" registration system. The recording was performed with a medical electroencephalograph NVX-36 ("Medical Computer Systems", Zelenograd, Russia). Electromyographic (EMG) activity of the flexor digitorum superficialis muscles of both hands was also recorded using surface electrodes. The EMG is recorded with the same amplifier as the EEG signal (NVX-36). The participant takes part in the test within 2 weeks. There were two sessions (at the beginning of rehabilitation and before discharge). Each session lasts a maximum of one hour.
Before the study, the participants' motor activity was tested using the Action Research Arm Test (ARAT). The EEG data were analysed for markers such as movement-related potentials and movement-related desynchronisation of alpha and beta rhythms. Some participants were also invited to take part in an additional study using transcranial magnetic stimulation to assess the integrity of corticospinal connections.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 21-75-30024 | OTHER_GRANT | Russian Science Foundation | View |