Navigation Repetitive Transcranial Magnetic Stimulation in Stroke Rehabilitation (NTMSR)

Russian Academy of Medical Sciences (RAMS)

Status and phase: Completed; Phase 4

Conditions: Stroke

Treatments: Procedure: Transcranial magnetic stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT01652677

TMS-001

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 4 patient groups

Low-frequency stimulation

Experimental group

Description:

Stimulation mode: 1 Hz, 100% MT, 20 minutes, unaffected hemisphere

Treatment:

Procedure: Transcranial magnetic stimulation

High frequency stimulation

Experimental group

Description:

Stimulation mode: 10 Hz, 80% MT, 2 seconds - stimulation, 58 seconds - rest. - 8 session; affected hemisphere

Treatment:

Procedure: Transcranial magnetic stimulation

Sham stimulation

Sham Comparator group

Description:

Patients will receive standard treatment (kinesotherapy, physiotherapy) and simulate of transcranial magnetic stimulation. Also patients will not know about simulation (blind group)

Treatment:

Procedure: Transcranial magnetic stimulation

Both hemispheric stimulation

Experimental group

Description:

Stimulation mode: low-frequency to unaffected hemisphere than high-frequency to affected.

Treatment:

Procedure: Transcranial magnetic stimulation