Clinical trial NCT01652677: Navigation Repetitive Transcranial Magnetic Stimulation in Stroke Rehabilitation
Official title: Randomized Controlled Single-blind Research "Navigation Repetitive Transcranial Magnetic Stimulation in Stroke Rehabilitation"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Stroke
Keywords: navigation transcranial magnetic stimulation
stroke rehabilitation
Lead sponsor: Russian Academy of Medical Sciences
Sponsor class: OTHER
First posted: 2012-07-30
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of research to study therapeutic possibilities of navigation transcranial magnetic stimulation in stroke rehabilitation, finding optimal protocol.

Detailed description: Stroke is the main cause of long-term disability among adults. Disability following stroke results in significant impairment of patients quality of life. There was a lot of investigations with using Transcranial Magnetic Stimulation (TMS) as effective additional therapy in stroke rehabilitation. In this researches uses different protocols and patient's categories: high-frequency, low-frequency, etc. Using method of navigation transcranial magnetic stimulation with neuroimaging could help in choosing optimal protocol, assess effectiveness of therapy and forming prognosis.

Eligibility criteria: Inclusion Criteria:

* a person with confirmed cerebral blood flow by ischemic from 8 days to 3 years in a pool of carotid arteries;
* 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 presence of an implanted pacemaker, intracardiac catheters, electronic pumps;
* 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;

Exclusion criteria were:

* 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;

Primary outcomes:
measure: Evidence of clinically definite ischemic stroke (focal neurological deficits persisting for more than 24 hours) confirmed by non-investigational CT or MRI
timeFrame: up to 20 days
measure: The emergence of epileptic seizure
timeFrame: up to 20 days
Secondary outcomes:
measure: Evaluation of the clinical condition of the patient
timeFrame: up to 20 days
Other outcomes:
measure: Pregnancy
timeFrame: up to 20 days
Locations:
city: Moscow, Volokolamskoe shosse, 80
country: Russian Federation
facility: Research center of neurology RAMS
city: Moscow
country: Russian Federation
facility: Research center of neurology Russian academy of medical science
Study officials:
affiliation: Research center of neurology Russian academy of medical science
name: Ludmila A. Chernikova
role: STUDY_CHAIR
affiliation: Research center of neurology RAMS
name: Michael A Piradov, professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.