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Navigation Repetitive Transcranial Magnetic Stimulation in Stroke Rehabilitation (NTMSR)

Primary Purpose

Stroke

Status
Completed
Phase
Phase 4
Locations
Russian Federation
Study Type
Interventional
Intervention
Transcranial magnetic stimulation
Sponsored by
Russian Academy of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring navigation transcranial magnetic stimulation, stroke rehabilitation

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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;

Sites / Locations

  • Research center of neurology RAMS
  • Research center of neurology Russian academy of medical science

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Sham Comparator

Experimental

Arm Label

Low-frequency stimulation

High frequency stimulation

Sham stimulation

Both hemispheric stimulation

Arm Description

Stimulation mode: 1 Hz, 100% MT, 20 minutes, unaffected hemisphere

Stimulation mode: 10 Hz, 80% MT, 2 seconds - stimulation, 58 seconds - rest. - 8 session; affected hemisphere

Patients will receive standard treatment (kinesotherapy, physiotherapy) and simulate of transcranial magnetic stimulation. Also patients will not know about simulation (blind group)

Stimulation mode: low-frequency to unaffected hemisphere than high-frequency to affected.

Outcomes

Primary Outcome Measures

Evidence of clinically definite ischemic stroke (focal neurological deficits persisting for more than 24 hours) confirmed by non-investigational CT or MRI
The emergence of epileptic seizure

Secondary Outcome Measures

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

Full Information

First Posted
June 28, 2012
Last Updated
April 30, 2015
Sponsor
Russian Academy of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01652677
Brief Title
Navigation Repetitive Transcranial Magnetic Stimulation in Stroke Rehabilitation
Acronym
NTMSR
Official Title
Randomized Controlled Single-blind Research "Navigation Repetitive Transcranial Magnetic Stimulation in Stroke Rehabilitation"
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Russian Academy of Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
navigation transcranial magnetic stimulation, stroke rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Low-frequency stimulation
Arm Type
Experimental
Arm Description
Stimulation mode: 1 Hz, 100% MT, 20 minutes, unaffected hemisphere
Arm Title
High frequency stimulation
Arm Type
Experimental
Arm Description
Stimulation mode: 10 Hz, 80% MT, 2 seconds - stimulation, 58 seconds - rest. - 8 session; affected hemisphere
Arm Title
Sham stimulation
Arm Type
Sham Comparator
Arm Description
Patients will receive standard treatment (kinesotherapy, physiotherapy) and simulate of transcranial magnetic stimulation. Also patients will not know about simulation (blind group)
Arm Title
Both hemispheric stimulation
Arm Type
Experimental
Arm Description
Stimulation mode: low-frequency to unaffected hemisphere than high-frequency to affected.
Intervention Type
Procedure
Intervention Name(s)
Transcranial magnetic stimulation
Other Intervention Name(s)
Transcranial magnetic stimulation, brain stimulation
Intervention Description
Transcranial magnetic stimulation is a noninvasive technique for including electrical currents in the cerebral cortex by means of time-varying magnetic fields.
Primary Outcome Measure Information:
Title
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
Title
The emergence of epileptic seizure
Time Frame
up to 20 days
Secondary Outcome Measure Information:
Title
Evaluation of the clinical condition of the patient
Description
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
Time Frame
up to 20 days
Other Pre-specified Outcome Measures:
Title
Pregnancy
Time Frame
up to 20 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ludmila A. Chernikova
Organizational Affiliation
Research center of neurology Russian academy of medical science
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Michael A Piradov, professor
Organizational Affiliation
Research center of neurology RAMS
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research center of neurology RAMS
City
Moscow, Volokolamskoe shosse, 80
ZIP/Postal Code
125367
Country
Russian Federation
Facility Name
Research center of neurology Russian academy of medical science
City
Moscow
ZIP/Postal Code
125367
Country
Russian Federation

12. IPD Sharing Statement

Citations:
PubMed Identifier
23885553
Citation
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.
Results Reference
background
PubMed Identifier
24319425
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.2013.00168. eCollection 2013.
Results Reference
result

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Navigation Repetitive Transcranial Magnetic Stimulation in Stroke Rehabilitation

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