Theta-Burst-Stimulation in Recurrent Stroke Recovery
A tanulmány áttekintése
Állapot
Körülmények
Beavatkozás / kezelés
Részletes leírás
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.
Tanulmány típusa
Beiratkozás (Várható)
Fázis
- 2. fázis
Kapcsolatok és helyek
Tanulmányi helyek
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Cologne, Németország, 50937
- Christian Grefkles
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Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
Egészséges önkénteseket fogad
Tanulmányozható nemek
Leírás
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
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Alapvető tudomány
- Kiosztás: Véletlenszerűsített
- Beavatkozó modell: Párhuzamos hozzárendelés
- Maszkolás: Hármas
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
|---|---|
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Aktív összehasonlító: Real-iTBS
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Intermittent theta-burst-stimulation (iTBS) protocol
Sham stimulation
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Sham Comparator: Sham-iTBS
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Intermittent theta-burst-stimulation (iTBS) protocol
Sham stimulation
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Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Relative grip force
Időkeret: 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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Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Relative grip force
Időkeret: After 8 days of intervention, and 3 months of enrollment
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Grip force as measured with vigorimeter
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After 8 days of intervention, and 3 months of enrollment
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Motor function
Időkeret: After 8 days of intervention, and 3 months of enrollment
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Action Research Arm Test, ARAT
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After 8 days of intervention, and 3 months of enrollment
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Motor function
Időkeret: After 8 days of intervention, and 3 months of enrollment
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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
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Stroke severity
Időkeret: After 8 days of intervention, and 3 months of enrollment
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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
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Degree of disability
Időkeret: After 8 days of intervention, and 3 months of enrollment
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Modified Rankin Scale, mRS The scale runs from 0-6, running from perfect health (0) without symptoms to death (6).
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After 8 days of intervention, and 3 months of enrollment
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Motor cortex excitability/ Motor evoked potential
Időkeret: After 8 days of intervention, and 3 months of enrollment
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Motor evoked potential (MEP) induced by stimulation of the affected motor cortex
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After 8 days of intervention, and 3 months of enrollment
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Motor cortex excitability/ Resting motor threshold
Időkeret: After 8 days of intervention, and 3 months of 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 of enrollment
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Motor cortex excitability/ Short-interval intracortical inhibition
Időkeret: After 8 days of intervention, and 3 months of enrollment
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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
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After 8 days of intervention, and 3 months of enrollment
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Motor cortex excitability/ Ipsilateral silent period
Időkeret: After 8 days of intervention, and 3 months of enrollment
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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.
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After 8 days of intervention, and 3 months of enrollment
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Quality of life
Időkeret: After 8 days of intervention, and 3 months of enrollment
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EuroQol 5D questionnaire, EQ-5D
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After 8 days of intervention, and 3 months of enrollment
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Activities of daily living at admission and discharge in external rehabilitation facility
Időkeret: After 8 days of intervention, and 3 months of enrollment
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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.
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After 8 days of intervention, and 3 months of enrollment
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Days of rehabilitation after intervention phase
Időkeret: 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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Együttműködők és nyomozók
Szponzor
Nyomozók
- Kutatásvezető: Christian Grefkes, MD, University Hospital Cologne
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete (Tényleges)
Elsődleges befejezés (Várható)
A tanulmány befejezése (Várható)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Tényleges)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- U1111-1204-6783
Terv az egyéni résztvevői adatokhoz (IPD)
Tervezi megosztani az egyéni résztvevői adatokat (IPD)?
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