Skip to main content
OpenTrials
Completed

NCT Number: NCT01652677

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Research center of neurology Russian academy of medical science, Moscow, Russia

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

Transcranial magnetic stimulation

Procedure

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

Primary outcomes

  1. 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

  2. The emergence of epileptic seizure

    Time frame: up to 20 days

Secondary outcomes

  1. 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

Other outcomes

  1. Pregnancy

    Time frame: up to 20 days

Sponsors and collaborators

Lead sponsor

Russian Academy of Medical Sciences

Other

Registry information

Official study title

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

Acronym: NTMSR

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jul 30, 2012
Registry last updated
May 1, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.