Navigation Repetitive Transcranial Magnetic Stimulation in Stroke Rehabilitation (NTMSR)

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: Stroke
• Intervention / Treatment: Procedure: Transcranial magnetic 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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 4

Contacts and Locations

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

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

How is the study designed?

Design Details

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

Number of Arms

4

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	up to 20 days
The emergence of epileptic seizure	up to 20 days

Secondary Outcome Measures

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

Collaborators and Investigators

• 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

General Publications

• 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.
• 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.

Helpful Links

• Capability of navigated repeated transcranial magnetic stimulation in stroke rehabilitation (Randomized blind sham-controlled study) (Clinicaltrials.gov identifier: NCT01652677)

Study record dates

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: stroke rehabilitation; navigation transcranial magnetic stimulation
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: TMS-001