Theta-Burst-Stimulation in Early Rehabilitation of Stroke (TheSiReS)
19. september 2022 opdateret af: Gereon R. Fink, University of Cologne
Theta-Burst-Stimulation in Der frühen Rehabilitation Von Schlaganfallpatienten
The present prospective, randomized, controlled, double-blinded trial investigates the effects of intermittent theta-burst stimulation (iTBS) during the early rehabilitation after stroke.
Patients with hemipresis will receive either sham or real iTBS over their affected hemispheres before occupational therapy for 8 days.
Motor recovery is assessed one day after the intervention phase and three months after enrollment.
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
To date, rehabilitation of stroke with hemiparesis mainly includes physiotherapy and occupational therapy. Yet, the majority of patients retain movement impairment relevant for activities of daily living. One explanation for this deficit is the insufficient recovery of connectivity between brain regions after stroke. It is possible to modulate this process by repetitive transcranial magnetic stimulation (rTMS) using the protocol of intermittent theta-burst stimulation (iTBS). Previous data indicate that modulation of the motor cortex with iTBS enhances the effects of subsequent motor training. The present study aims at investigating whether daily repetitive transcranial magnetic stimulation over 8 days combined with subsequent physiotherapy leads to better motor recovery, compared with physiotherapy after sham stimulation. In the first weeks and after three months, motor function, degree of disability and quality of life are examined in order to evaluate the effects of iTBS in the rehabilitation of stroke patients.
Amendment (approved by the Ethics-Committee of the Medical Faculty of the University of Cologne, 20/12/2016): Specification of exclusion criteria.
Amendment (approved by the Ethics-Committee of the Medical Faculty of the University of Cologne, 15/11/2018): Change of inclusion and exclusion criteria.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
150
Fase
- Fase 2
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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North Rhine-Westphalia
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Cologne, North Rhine-Westphalia, Tyskland, 50924
- Klinik und Poliklinik für Neurologie, Universitätsklinikum Köln
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
40 år til 90 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- written consent
- age: 40-90 years
- ischemic stroke
- hemiparesis with impaired hand motor function
Exclusion Criteria:
- Subjects who are legally detained in an official institute (§20 MPG)
- Participation in clinical trial within the last 12 weeks
- Electronic implants or ferromagnetic Implants located in the head, neck or thorax (e.g. clips, intracranial shunt, artificial heart valve, pacemaker)
- Medication pump (e.g. insulin pump)
- Metal splinters in eye or head
- Pregnancy / breastfeeding
- Severe Neurodegenerative disease
- Severe Neuroinflammatory disease
- History of seizures / epilepsy
- Physical addiction to alcohol, medication, or drugs (excluded: nicotine)
- Insufficient compliance
- Present or past malignant tumor involving the central nervous system
- Severe Psychiatric disease
- Clinically manifest bilateral hemiparesis or infarcts in the primary motor cortex or along the tractus corticospinalis in the hemisphere ipsilateral to the hemiparesis
- Pre-existing cerebral infarctions with hemiparesis or pre-existing cerebral infarctions in the primary motor cortex or along the tractus corticospinalis, excluding microangiopathic changes (e.g. clinically asymptomatic lacunae <1cm)
- Known brain lesion (surgical, traumatic)
- Evidence for enhanced cerebral pressure
- Severe cardial dysfunction
- life expectancy < 12 months
- NIHSS Score > 20
- Blood glucose imbalances resistant to treatment (<50 mg/dl or >300 mg/dl)
- Elevated blood pressure resistant to treatment (RR > 185/110mmHg)
- Systemic Thrombolysis using r-tPA or thrombectomy within the last 24 hours before enrollment in study
- Medication with benzodiazepines, high-potency antipsychotics or tricyclic antidepressants before hospitalization or long-term during hospitalization
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Aktiv komparator: Real-rTMS
Repetitive transcranial magnetic stimulation (rTMS) of the primary motor cortex in the lesioned hemisphere using the intermittent theta-burst-stimulation protocol (iTBS; application of 3 pulses with a frequency of 50 Hz, in a theta-rhythm of 5 Hz for 2 seconds, repeated every 10 seconds, duration of one session: about 3,5 minutes) before physiotherapy for 8 days
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iTBS applied over ipsilesional M1
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Sham-komparator: Sham-rTMS
Repetitive transcranial magnetic stimulation (rTMS) in sham position (tilted coil over parieto-occipital vertex) before physiotherapy for 8 days
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iTBS applied with tilted coil over parieto-occipital vertex
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Relative grip force
Tidsramme: 3 months after enrollment
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grip force as measured with vigorimeter
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3 months after enrollment
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Days of rehabilitation after intervention phase
Tidsramme: 3 months after enrollment
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Days of rehabilitation after intervention phase as documented by external rehabilitation facility
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3 months after enrollment
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Relative grip force
Tidsramme: after 8 days of intervention, and 3 months after enrollment
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grip force as measured with vigorimeter
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after 8 days of intervention, and 3 months after enrollment
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Motor function
Tidsramme: after 8 days of intervention, and 3 months after enrollment
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Action Research Arm Test, ARAT
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after 8 days of intervention, and 3 months after enrollment
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Motor function
Tidsramme: after 8 days of intervention, and 3 months after enrollment
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Fugl-Meyer Motor Scale of the upper extremity, FM
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after 8 days of intervention, and 3 months after enrollment
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Stroke severity
Tidsramme: after 8 days of intervention, and 3 months after enrollment
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National Instituts of Health Stroke Scale, NIHSS
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after 8 days of intervention, and 3 months after enrollment
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Degree of disability
Tidsramme: after 8 days of intervention, and 3 months after enrollment
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modified Rankin Scale, mRS
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after 8 days of intervention, and 3 months after enrollment
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Motorcortex excitability
Tidsramme: after 8 days of intervention, and 3 months after enrollment
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Motor evoked potential induced by stimulation of the affected motor cortex, MEP
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after 8 days of intervention, and 3 months after enrollment
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Motorcortex excitability
Tidsramme: after 8 days of intervention, and 3 months after enrollment
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Resting motor threshold as measured by stimulation of the affected motor cortex, RMT
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after 8 days of intervention, and 3 months after enrollment
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Quality of life
Tidsramme: after 8 days of intervention, and 3 months after enrollment
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EuroQol 5D questionnaire, EQ-5D
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after 8 days of intervention, and 3 months after enrollment
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Activities of daily living at admission and discharge in external rehabilitation facility
Tidsramme: 3 months after enrollment
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Barthel-Index (BI) scores as documented by external rehabilitation facility
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3 months after enrollment
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Gereon R Fink, Univ.-Prof. Dr., University of Cologne
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. april 2016
Primær færdiggørelse (Faktiske)
15. september 2022
Studieafslutning (Faktiske)
15. september 2022
Datoer for studieregistrering
Først indsendt
8. september 2016
Først indsendt, der opfyldte QC-kriterier
19. september 2016
Først opslået (Skøn)
21. september 2016
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
21. september 2022
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
19. september 2022
Sidst verificeret
1. september 2022
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- Uni-Koeln-1778
- U1111-1172-6026 (Anden identifikator: WHO)
- CIV-15-09-013868 (Anden identifikator: EUDAMED)
- DRKS00008963 (Registry Identifier: DRKS)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
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