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Navigation Repetitive Transcranial Magnetic Stimulation in Stroke Rehabilitation (NTMSR)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Chervyakov Alexander, Russian Academy of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01652677
First received: June 28, 2012
Last updated: November 5, 2014
Last verified: November 2014

June 28, 2012
November 5, 2014
January 2012
December 2014   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01652677 on ClinicalTrials.gov Archive Site
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
Same as current
Pregnancy [ Time Frame: up to 20 days ] [ Designated as safety issue: No ]
Same as current
 
Navigation Repetitive Transcranial Magnetic Stimulation in Stroke Rehabilitation
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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Stroke
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: Low-frequency stimulation
    Stimulation mode: 1 Hz, 100% MT, 20 minutes, unaffected hemisphere
    Intervention: Procedure: Transcranial magnetic stimulation
  • Experimental: High frequency stimulation
    Stimulation mode: 10 Hz, 80% MT, 2 seconds - stimulation, 58 seconds - rest. - 8 session; affected hemisphere
    Intervention: Procedure: Transcranial magnetic 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)
    Intervention: Procedure: Transcranial magnetic stimulation
  • Experimental: Both hemispheric stimulation
    Stimulation mode: low-frequency to unaffected hemisphere than high-frequency to affected.
    Intervention: Procedure: Transcranial magnetic stimulation

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
100
December 2014
December 2014   (final data collection date for primary outcome measure)

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;
Both
18 Years to 70 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Russian Federation
 
NCT01652677
TMS-001
Yes
Chervyakov Alexander, Russian Academy of Medical Sciences
Russian Academy of Medical Sciences
Not Provided
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
Russian Academy of Medical Sciences
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP