NTMSR: Navigation Repetitive Transcranial Magnetic Stimulation in Stroke Rehabilitation

Sponsor

Russian Academy of Medical Sciences (Other)

Overall Status

Completed

CT.gov ID

NCT01652677

Collaborator

(none)

100

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

1.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Stroke	Procedure: Transcranial magnetic stimulation	Phase 4

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

Randomized Controlled Single-blind Research "Navigation Repetitive Transcranial Magnetic Stimulation in Stroke Rehabilitation"

Study Start Date :

Jan 1, 2012

Actual Primary Completion Date :

Nov 1, 2014

Actual Study Completion Date :

Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Low-frequency stimulation Stimulation mode: 1 Hz, 100% MT, 20 minutes, unaffected hemisphere	Procedure: 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 Names: Transcranial magnetic stimulation, brain stimulation
Experimental: High frequency stimulation Stimulation mode: 10 Hz, 80% MT, 2 seconds - stimulation, 58 seconds - rest. - 8 session; affected hemisphere	Procedure: 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 Names: Transcranial magnetic stimulation, brain stimulation
Sham Comparator: Sham stimulation Patients will receive standard treatment (kinesotherapy, physiotherapy) and simulate of transcranial magnetic stimulation. Also patients will not know about simulation (blind group)	Procedure: 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 Names: Transcranial magnetic stimulation, brain stimulation
Experimental: Both hemispheric stimulation Stimulation mode: low-frequency to unaffected hemisphere than high-frequency to affected.	Procedure: 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 Names: Transcranial magnetic stimulation, brain stimulation

Outcome Measures

Primary Outcome Measures

Evidence of clinically definite ischemic stroke (focal neurological deficits persisting for more than 24 hours) confirmed by non-investigational CT or MRI [up to 20 days]
The emergence of epileptic seizure [up to 20 days]

Secondary Outcome Measures

Evaluation of the clinical condition of the patient [up to 20 days]
We plan to use different scales to examine clinical condition of patient: Fugl-Meyer scale, Ashworth scale, Perry scale, test with 10 meters walking, Bartel index, Renkin scale

Other Outcome Measures

Pregnancy [up to 20 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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;

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research center of neurology RAMS	Moscow, Volokolamskoe shosse, 80		Russian Federation	125367
2	Research center of neurology Russian academy of medical science	Moscow		Russian Federation	125367

Sponsors and Collaborators

Russian Academy of Medical Sciences

Investigators

Study Chair: Ludmila A. Chernikova, Research center of neurology Russian academy of medical science
Principal Investigator: Michael A Piradov, professor, Research center of neurology RAMS