NCT01652677

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P25-P50 for phase_4 stroke

Timeline
Completed

Started Jan 2012

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 28, 2012

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 30, 2012

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

May 1, 2015

Status Verified

April 1, 2015

Enrollment Period

2.8 years

First QC Date

June 28, 2012

Last Update Submit

April 30, 2015

Conditions

Stroke

Keywords

navigation transcranial magnetic stimulationstroke rehabilitation

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • Evaluation of the clinical condition of the patient

    up to 20 days

Other Outcomes (1)

  • Pregnancy

    up to 20 days

Study Arms (4)

Low-frequency stimulation

EXPERIMENTAL

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

Procedure: Transcranial magnetic stimulation

High frequency stimulation

EXPERIMENTAL

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

Procedure: Transcranial magnetic stimulation

Sham stimulation

SHAM COMPARATOR

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

Both hemispheric stimulation

EXPERIMENTAL

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

Procedure: Transcranial magnetic stimulation

Interventions

Transcranial magnetic stimulationPROCEDURE

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

Also known as: Transcranial magnetic stimulation, brain stimulation
Both hemispheric stimulationHigh frequency stimulationLow-frequency stimulationSham stimulation

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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;
  • Identified in the study of the general intolerance of the pulsed magnetic field;
  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Research center of neurology Russian academy of medical science

Moscow, 125367, Russia

Location

Research center of neurology RAMS

Moscow, Volokolamskoe Shosse, 80, 125367, Russia

Location

Related 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. doi: 10.7868/s0131164613030053. Russian.

    PMID: 23885553BACKGROUND

  • 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.

    PMID: 24319425RESULT

MeSH Terms

Conditions

Stroke

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Study Officials

  • Ludmila A. Chernikova

    Research center of neurology Russian academy of medical science

    STUDY CHAIR

  • Michael A Piradov, professor

    Research center of neurology RAMS

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher

Study Record Dates

First Submitted

June 28, 2012

First Posted

July 30, 2012

Study Start

January 1, 2012

Primary Completion

November 1, 2014

Study Completion

December 1, 2014

Last Updated

May 1, 2015

Record last verified: 2015-04

Locations

RU(2)