Theta-Burst-Stimulation in Recurrent Stroke Recovery
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
To date, the majority of neuromodulation approaches aiming at improving motor recovery after stroke are limited to patients with first-ever ischemic stroke. Therefore, rehabilitation of recurrent stroke mainly includes physiotherapy and occupational therapy. Yet, particular these patients retain movement impairment relevant for activities of daily living.
By using repetitive transcranial magnetic stimulation (rTMS), it is possible to promote recovery of connectivity between brain regions, particularly after stroke and thereby improve motor performance. Previous data indicate that intermittent theta-burst stimulation (iTBS), a protocol of neuromodulation, enhances the effects of subsequent motor training in early rehabilitation after stroke.
The current study aims at investigating whether daily repetitive transcranial magnetic stimulation over 8 days combined with subsequent physiotherapy leads to better motor recovery in recurrent stroke, compared to control condition, physiotherapy after sham stimulation. Motor function, degree of disability and quality of life are examined in order to evaluate the effects of iTBS in the rehabilitation of recurrent stroke patients in the first weeks and after three months.
Typ studie
Zápis (Očekávaný)
Fáze
- Fáze 2
Kontakty a umístění
Studijní místa
-
-
-
Cologne, Německo, 50937
- Christian Grefkles
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- written consent
- age: 40-90 years
- recurrent stroke
- hemiparesis with impaired hand motor function
Exclusion Criteria:
- Subjects who are legally detained in an official institute (§20 MPG)
- 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
- Frequent medication with benzodiazepines, high-potency antipsychotics or tricyclic antidepressants before hospitalization or long-term during hospitalization
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Základní věda
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Trojnásobný
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Aktivní komparátor: Real-iTBS
|
Intermittent theta-burst-stimulation (iTBS) protocol
Sham stimulation
|
|
Falešný srovnávač: Sham-iTBS
|
Intermittent theta-burst-stimulation (iTBS) protocol
Sham stimulation
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Relative grip force
Časové okno: 3 months after enrollment
|
grip force as measured with vigorimeter
|
3 months after enrollment
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Relative grip force
Časové okno: After 8 days of intervention, and 3 months of enrollment
|
Grip force as measured with vigorimeter
|
After 8 days of intervention, and 3 months of enrollment
|
|
Motor function
Časové okno: After 8 days of intervention, and 3 months of enrollment
|
Action Research Arm Test, ARAT
|
After 8 days of intervention, and 3 months of enrollment
|
|
Motor function
Časové okno: After 8 days of intervention, and 3 months of enrollment
|
Fugl-Meyer Motor Scale of the upper extremity, FM The Fugl-Meyer Assessment scale is an ordinal scale that has 3 points for each item. A zero score is given for the item if the subject cannot do the task. A score of 1 is given when the task is performed partially and a score of 2 is given when the task is performed fully. Minimum score in upper limb = 0 Maximum score in upper limb = 66, Subscales are summed |
After 8 days of intervention, and 3 months of enrollment
|
|
Stroke severity
Časové okno: After 8 days of intervention, and 3 months of enrollment
|
National Instituts of Health Stroke Scale, NIHSS The NIHSS is composed of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. The individual scores from each item are summed in order to calculate a patient's total NIHSS score. The maximum possible score is 42, with the minimum score being a 0. |
After 8 days of intervention, and 3 months of enrollment
|
|
Degree of disability
Časové okno: After 8 days of intervention, and 3 months of enrollment
|
Modified Rankin Scale, mRS The scale runs from 0-6, running from perfect health (0) without symptoms to death (6).
|
After 8 days of intervention, and 3 months of enrollment
|
|
Motor cortex excitability/ Motor evoked potential
Časové okno: After 8 days of intervention, and 3 months of enrollment
|
Motor evoked potential (MEP) induced by stimulation of the affected motor cortex
|
After 8 days of intervention, and 3 months of enrollment
|
|
Motor cortex excitability/ Resting motor threshold
Časové okno: After 8 days of intervention, and 3 months of enrollment
|
Resting motor threshold as measured by stimulation of the affected motor cortex, RMT
|
After 8 days of intervention, and 3 months of enrollment
|
|
Motor cortex excitability/ Short-interval intracortical inhibition
Časové okno: After 8 days of intervention, and 3 months of enrollment
|
Short-interval intracortical inhibition Short-interval intracortical inhibition (SICI) is a widely used paired-pulse transcranial magnetic stimulation (TMS) measure to assess inhibition in human motor cortex
|
After 8 days of intervention, and 3 months of enrollment
|
|
Motor cortex excitability/ Ipsilateral silent period
Časové okno: After 8 days of intervention, and 3 months of enrollment
|
Ipsilateral silent period The ipsilateral silent period (iSP) is supposed to be a specific marker of transcallosal motor inhibition.
Measured by a short attenuation or interruption of ongoing voluntary electromyographic (EMG) activity in hand muscles induced by focal TMS of the ipsilateral M1.
|
After 8 days of intervention, and 3 months of enrollment
|
|
Quality of life
Časové okno: After 8 days of intervention, and 3 months of enrollment
|
EuroQol 5D questionnaire, EQ-5D
|
After 8 days of intervention, and 3 months of enrollment
|
|
Activities of daily living at admission and discharge in external rehabilitation facility
Časové okno: After 8 days of intervention, and 3 months of enrollment
|
Barthel-Index (BI) scores as documented by external rehabilitation facility The Barthel scale is an ordinal scale used to measure performance in activities of daily living (ADL).
A higher number is associated with a greater likelihood of being able to live at home with a degree of independence following discharge from hospital.
The scale yield a score of 0-100.
|
After 8 days of intervention, and 3 months of enrollment
|
|
Days of rehabilitation after intervention phase
Časové okno: 3 months after enrollment
|
Days of rehabilitation after intervention phase as documented by external rehabilitation facility
|
3 months after enrollment
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Christian Grefkes, MD, University Hospital Cologne
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Očekávaný)
Dokončení studie (Očekávaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- U1111-1204-6783
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
Klinické studie na Magstim Super Rapid2 System
-
NYU Langone HealthDokončenoEpilepsieSpojené státy
-
vghtpe userNeznámý
-
UMC UtrechtDokončeno
-
Bradley HospitalThrasher Research Fund; Rhode Island FoundationNeznámýADHD s deficitem pracovní pamětiSpojené státy
-
Taipei Medical University WanFang HospitalDokončeno
-
University of ManitobaNáborLogopenická progresivní afázieKanada
-
Ankara City Hospital BilkentDokončenoDeprese po mrtviciKrocan
-
New York State Psychiatric InstituteDokončenoPorucha depersonalizaceSpojené státy
-
Ankara City Hospital BilkentDokončeno
-
Yale UniversityAmerican Academy of Child Adolescent Psychiatry.NáborPoruchou autistického spektraSpojené státy