NCT06386627Completed
Study of Neurophysiological Markers of Motor Recovery in Post-stroke Patients.
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.
Source: ClinicalTrials.gov · Last updated 23 May 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 40 (actual)
- First submitted
- 23 Apr 2024
- Start date
- 1 Jul 2023
- Primary completion date
- 15 Mar 2024
- Lead sponsor
- Skolkovo Institute of Science and Technology
- Diseases
- Stroke
- NCT number
- NCT06386627
What you commit to
- Study type: Observational
- Participants enrolled: 40
- From 1 Jul 2023 to the primary completion date, 15 Mar 2024
- 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
- Drug addiction in the past or at the moment.
- 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).
- 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.
- Unstable angina and/or heart attack within the previous month
Other illness
- 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).
- 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).
- Any conditions that, in the opinion of the Investigator, meet the exclusion criteria
- The presence of malignant neoplasms (C00-C97 ICD-10).
- For stroke patients:
- Severe cognitive impairment (\<10 points according to the Montreal Cognitive Assessment Scale).
- 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).
- Any medical condition, including mental illness or epilepsy, that may affect the interpretation of study results, study conduct, or patient safety.
- The severity of the patient's condition according to the neurological or somatic status, which does not allow full rehabilitation.
- Repeated stroke.
- Uncontrolled arterial hypertension
- All forms of epilepsy
Other
- Pregnancy
- Hamilton score above 18 points.
- The score on the Rankin scale is above 4 points.
- 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.
- Lack of ability to follow study procedures, in the opinion of the investigator.
- Severe visual disturbances, minimal visual acuity less than 0.2 Sivtsev visual acuity table.
- Severe unilateral spatial neglect.
- Ataxia
Who the study is looking for
- 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.
Criteria the registry did not label
- For Healthy Volunteers:
Age in the registry: 30 years to 70 years · Sex: All · Accepts 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 |
|---|---|---|---|
| Skolkovo Institute of Science and Technology (Skoltech) Coordinator of this site? Confirm its status | Moscow | Russia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.