Navigation Repetitive Transcranial Magnetic Stimulation in Stroke Rehabilitation

Stroke Clinical Trial

— NTMSR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01652677
• Other study ID #: TMS-001
• Status: Completed
• Phase: Phase 4
• First received: June 28, 2012
• Last updated: April 30, 2015
• Start date: January 2012
• Est. completion date: December 2014

Study information

• Verified date: April 2015
• Source: Russian Academy of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: Ministry of Health of the Russian Federation
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stroke

Intervention

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.

Locations

Country	Name	City	State
Russian Federation	Research center of neurology Russian academy of medical science	Moscow
Russian Federation	Research center of neurology RAMS	Moscow, Volokolamskoe shosse, 80

Sponsors (1)

Lead Sponsor	Collaborator
Russian Academy of Medical Sciences

Country where clinical trial is conducted

Russian Federation, 

References & Publications (2)

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. Russian. — View Citation

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.2 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Pregnancy		up to 20 days	No
Primary	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	Yes
Primary	The emergence of epileptic seizure		up to 20 days	Yes
Secondary	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	No

External Links

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