Navigation Repetitive Transcranial Magnetic Stimulation in Stroke Rehabilitation (NTMSR)

April 30, 2015 updated by: Chervyakov Alexander, Russian Academy of Medical Sciences

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Moscow, Russian Federation, 125367
        • Research center of neurology Russian academy of medical science
      • Moscow, Volokolamskoe shosse, 80, Russian Federation, 125367
        • Research center of neurology RAMS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of the clinical condition of the patient
Time Frame: 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
up to 20 days

Other Outcome Measures

Outcome Measure
Time Frame
Pregnancy
Time Frame: up to 20 days
up to 20 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

November 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

June 28, 2012

First Submitted That Met QC Criteria

July 27, 2012

First Posted (Estimate)

July 30, 2012

Study Record Updates

Last Update Posted (Estimate)

May 1, 2015

Last Update Submitted That Met QC Criteria

April 30, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TMS-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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