Navigation Repetitive Transcranial Magnetic Stimulation in Stroke Rehabilitation

NCT ID: NCT01652677

Last Updated: 2015-05-01

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2014-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Low-frequency stimulation

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

Group Type EXPERIMENTAL

Transcranial magnetic stimulation

Intervention Type PROCEDURE

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

Group Type EXPERIMENTAL

Transcranial magnetic stimulation

Intervention Type PROCEDURE

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)

Group Type SHAM_COMPARATOR

Transcranial magnetic stimulation

Intervention Type PROCEDURE

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.

Group Type EXPERIMENTAL

Transcranial magnetic stimulation

Intervention Type PROCEDURE

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.

Intervention Type PROCEDURE

Other Intervention Names

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Transcranial magnetic stimulation, brain stimulation

Eligibility Criteria

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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;


* 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;
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Russian Academy of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Chervyakov Alexander

Researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Research center of neurology RAMS

Moscow, Volokolamskoe Shosse, 80, , Russia

Site Status

Countries

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Russia

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.

Reference Type BACKGROUND
PMID: 23885553 (View on PubMed)

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.

Reference Type RESULT
PMID: 24319425 (View on PubMed)

Other Identifiers

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TMS-001

Identifier Type: -

Identifier Source: org_study_id

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