Navigation Repetitive Transcranial Magnetic Stimulation in Stroke Rehabilitation (NTMSR)
Randomized Controlled Single-blind Research "Navigation Repetitive Transcranial Magnetic Stimulation in Stroke Rehabilitation"
Studieoversigt
Status
Status
Betingelser
Betingelser
Intervention / Behandling
Intervention / Behandling
Detaljeret beskrivelse
Undersøgelsestype
Undersøgelsestype
Tilmelding (Forventet)
Tilmelding
Fase
Fase
- Fase 4
Kontakter og lokationer
Studiesteder
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Moscow, Den Russiske Føderation, 125367
- Research center of neurology Russian academy of medical science
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Moscow, Volokolamskoe shosse, 80, Den Russiske Føderation, 125367
- Research center of neurology RAMS
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Deltagelseskriterier
Berettigelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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;
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Antal våben
Våben og indgreb
Deltagergruppe / ArmDeltagergruppe / Arm |
Intervention / BehandlingIntervention / Behandling |
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Eksperimentel: Low-frequency stimulation
Stimulation mode: 1 Hz, 100% MT, 20 minutes, unaffected hemisphere
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Transcranial magnetic stimulation is a noninvasive technique for including electrical currents in the cerebral cortex by means of time-varying magnetic fields.
Andre navne:
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Eksperimentel: High frequency stimulation
Stimulation mode: 10 Hz, 80% MT, 2 seconds - stimulation, 58 seconds - rest.
- 8 session; affected hemisphere
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Transcranial magnetic stimulation is a noninvasive technique for including electrical currents in the cerebral cortex by means of time-varying magnetic fields.
Andre navne:
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Sham-komparator: Sham stimulation
Patients will receive standard treatment (kinesotherapy, physiotherapy) and simulate of transcranial magnetic stimulation.
Also patients will not know about simulation (blind group)
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Transcranial magnetic stimulation is a noninvasive technique for including electrical currents in the cerebral cortex by means of time-varying magnetic fields.
Andre navne:
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Eksperimentel: Both hemispheric stimulation
Stimulation mode: low-frequency to unaffected hemisphere than high-frequency to affected.
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Transcranial magnetic stimulation is a noninvasive technique for including electrical currents in the cerebral cortex by means of time-varying magnetic fields.
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Primære resultatmål
Resultatmål |
Tidsramme |
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Evidence of clinically definite ischemic stroke (focal neurological deficits persisting for more than 24 hours) confirmed by non-investigational CT or MRI
Tidsramme: up to 20 days
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up to 20 days
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The emergence of epileptic seizure
Tidsramme: up to 20 days
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up to 20 days
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Sekundære resultatmål
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Evaluation of the clinical condition of the patient
Tidsramme: up to 20 days
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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
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up to 20 days
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Andre resultatmål
Andre resultatmål
Resultatmål |
Tidsramme |
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Pregnancy
Tidsramme: up to 20 days
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up to 20 days
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Samarbejdspartnere og efterforskere
Sponsor
Sponsor
Efterforskere
Efterforskere
- Studiestol: Ludmila A. Chernikova, Research center of neurology Russian academy of medical science
- Ledende efterforsker: Michael A Piradov, professor, Research center of neurology RAMS
Publikationer og nyttige links
Generelle publikationer
- 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.
Datoer for undersøgelser
Studer store datoer
Studiestart
Studiestart
Primær færdiggørelse (Faktiske)
Primær færdiggørelse
Studieafslutning (Faktiske)
Studieafslutning
Datoer for studieregistrering
Først indsendt
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Først opslået
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering sendt
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
Andre undersøgelses-id-numre
- TMS-001
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