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Navigation Repetitive Transcranial Magnetic Stimulation in Stroke Rehabilitation

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01652677
Acronym
NTMSR
Enrollment
100
Registered
2012-07-30
Start date
2012-01-31
Completion date
2014-12-31
Last updated
2015-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Keywords

navigation transcranial magnetic stimulation, stroke rehabilitation

Brief summary

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

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.

Interventions

PROCEDURETranscranial magnetic stimulation

Transcranial magnetic stimulation is a noninvasive technique for including electrical currents in the cerebral cortex by means of time-varying magnetic fields.

Sponsors

Russian Academy of Medical Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes

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;

Design outcomes

Primary

MeasureTime frame
Evidence of clinically definite ischemic stroke (focal neurological deficits persisting for more than 24 hours) confirmed by non-investigational CT or MRIup to 20 days
The emergence of epileptic seizureup to 20 days

Secondary

MeasureTime frameDescription
Evaluation of the clinical condition of the patientup to 20 daysWe 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

MeasureTime frame
Pregnancyup to 20 days

Countries

Russia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026