Navigation Repetitive Transcranial Magnetic Stimulation in Stroke Rehabilitation
NCT ID: NCT01652677
Last Updated: 2015-05-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
100 participants
INTERVENTIONAL
2012-01-31
2014-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Low-frequency stimulation
Stimulation mode: 1 Hz, 100% MT, 20 minutes, unaffected hemisphere
Transcranial magnetic stimulation
Transcranial magnetic stimulation is a noninvasive technique for including electrical currents in the cerebral cortex by means of time-varying magnetic fields.
High frequency stimulation
Stimulation mode: 10 Hz, 80% MT, 2 seconds - stimulation, 58 seconds - rest. - 8 session; affected hemisphere
Transcranial magnetic stimulation
Transcranial magnetic stimulation is a noninvasive technique for including electrical currents in the cerebral cortex by means of time-varying magnetic fields.
Sham stimulation
Patients will receive standard treatment (kinesotherapy, physiotherapy) and simulate of transcranial magnetic stimulation. Also patients will not know about simulation (blind group)
Transcranial magnetic stimulation
Transcranial magnetic stimulation is a noninvasive technique for including electrical currents in the cerebral cortex by means of time-varying magnetic fields.
Both hemispheric stimulation
Stimulation mode: low-frequency to unaffected hemisphere than high-frequency to affected.
Transcranial magnetic stimulation
Transcranial magnetic stimulation is a noninvasive technique for including electrical currents in the cerebral cortex by means of time-varying magnetic fields.
Interventions
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Transcranial magnetic stimulation
Transcranial magnetic stimulation is a noninvasive technique for including electrical currents in the cerebral cortex by means of time-varying magnetic fields.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Persons with acute cerebrovascular accidents related to the severity of stroke scale NIHSS (National Institute of Health Stroke Scale) from 5 to 20 points;
* People with cerebral circulatory assessment on the modified Rankin scale at most 3;
* the availability of informed consent;
* healthy volunteers who gave informed consent to participate in the study.
Exclusion Criteria
* The plight of the patient, requiring the maintenance of vital functions by hardware (mechanical ventilation, continuous application infusomats), including an increase of neurological symptoms after 8 days from the start of CVD, myocardial infarction, venous thrombosis of lower extremities, episodes of pulmonary embolism;
* The severity of neurological deficit, which does not allow the patient to pass on their own 10 meters (you can use additional support);
* Pregnancy or possibility of pregnancy in women of childbearing age (before menopause), according to a pregnancy test;
* The presence of metallic elements or implants in the head region, located closer than 20 cm from the edge of the surface coil magnetic stimulator, with the exception of the mouth (metal brackets, vascular sutures, metal plates that cover the defects of the skull, metallic foreign body in the cranial cavity);
* Identification of epileptiform activity during the screening of EEG before the study;
* Epilepsy or seizures in history;
* Patient refusal to participate in the study;
* Identified in the study of the general intolerance of the pulsed magnetic field;
* The development of inclusion in the study after acute myocardial infarction and acute cerebral circulatory disorders;
* Setting the pacemaker, intracardiac catheters, or operations on the brain, requiring the abandonment of metallic objects in the cranial cavity;
* The onset of pregnancy;
* Enhancement of the patient, requiring the maintenance of vital functions by hardware (mechanical ventilation);
* The emergence of an epileptic seizure in response to the rhythmic TMS;
* Patient refusal to continue participation in the study;
18 Years
70 Years
ALL
Yes
Sponsors
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Russian Academy of Medical Sciences
OTHER
Responsible Party
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Chervyakov Alexander
Researcher
Principal Investigators
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Ludmila A. Chernikova
Role: STUDY_CHAIR
Research center of neurology Russian academy of medical science
Michael A Piradov, professor
Role: PRINCIPAL_INVESTIGATOR
Research center of neurology RAMS
Locations
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Research center of neurology Russian academy of medical science
Moscow, , Russia
Research center of neurology RAMS
Moscow, Volokolamskoe Shosse, 80, , Russia
Countries
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References
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Chernikova LA, Kremneva EI, Cherviakov AV, Saenko IV, Konovalov RN, Piramidov MA, Kozlovskaia IB. [New approaches in the study of neuroplasticity process in patients with central nervous system lesion]. Fiziol Cheloveka. 2013 May-Jun;39(3):54-60. doi: 10.7868/s0131164613030053. Russian.
Mokienko OA, Chervyakov AV, Kulikova SN, Bobrov PD, Chernikova LA, Frolov AA, Piradov MA. Increased motor cortex excitability during motor imagery in brain-computer interface trained subjects. Front Comput Neurosci. 2013 Nov 22;7:168. doi: 10.3389/fncom.2013.00168. eCollection 2013.
Other Identifiers
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TMS-001
Identifier Type: -
Identifier Source: org_study_id
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