Navigation Repetitive Transcranial Magnetic Stimulation in Stroke Rehabilitation (NTMSR)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Russian Academy of Medical Sciences
Sponsor:
Information provided by (Responsible Party):
Chervyakov Alexander, Russian Academy of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01652677
First received: June 28, 2012
Last updated: April 22, 2013
Last verified: April 2013
  Purpose

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


Condition Intervention Phase
Stroke
Procedure: Transcranial magnetic stimulation
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Randomized Controlled Single-blind Research "Navigation Repetitive Transcranial Magnetic Stimulation in Stroke Rehabilitation"

Resource links provided by NLM:


Further study details as provided by Russian Academy of Medical Sciences:

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 [ Time Frame: up to 20 days ] [ Designated as safety issue: Yes ]
  • The emergence of epileptic seizure [ Time Frame: up to 20 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Evaluation of the clinical condition of the patient [ Time Frame: up to 20 days ] [ Designated as safety issue: No ]
    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 [ Time Frame: up to 20 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: January 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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 Name: 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 Name: Transcranial magnetic stimulation, brain stimulation

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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;
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01652677

Contacts
Contact: Alexander V. Chervyakov, PhD +79161831088 tchervyakovav@gmail.com
Contact: Ludmila A. Chernikova, Professor luda_cher44@mail.ru

Locations
Russian Federation
Research center of neurology Russian academy of medical science Recruiting
Moscow, Russian Federation, 125367
Contact: Alexander Chervyakov, PhD    +79161831088    tchervyakovav@gmail.com   
Contact: Lumila A Chernikova, professor       luda_cher44@mail.ru   
Principal Investigator: Michael A Piradov, professor         
Sub-Investigator: Alexander V Chervyakov, Phd         
Sub-Investigator: Ludmila A Chernikova, professor         
Research center of neurology RAMS Recruiting
Moscow, Volokolamskoe shosse, 80, Russian Federation, 125367
Contact: Michael A Piradov, professor         
Contact: Ludmila A Chernikova, professor         
Principal Investigator: Alexander V Chervyakov, PhD         
Principal Investigator: Savitskaya G Natalia, PhD         
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
  More Information

No publications provided

Responsible Party: Chervyakov Alexander, Researcher, Russian Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT01652677     History of Changes
Other Study ID Numbers: TMS-001
Study First Received: June 28, 2012
Last Updated: April 22, 2013
Health Authority: Russia: Ministry of Health of the Russian Federation

Keywords provided by Russian Academy of Medical Sciences:
navigation transcranial magnetic stimulation
stroke rehabilitation

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on July 20, 2014