Theta-Burst-Stimulation in Recurrent Stroke Recovery
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Verwacht)
Fase
- Fase 2
Contacten en locaties
Studie Locaties
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Cologne, Duitsland, 50937
- Christian Grefkles
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Fundamentele wetenschap
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verdrievoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Actieve vergelijker: Real-iTBS
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Intermittent theta-burst-stimulation (iTBS) protocol
Sham stimulation
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Sham-vergelijker: Sham-iTBS
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Intermittent theta-burst-stimulation (iTBS) protocol
Sham stimulation
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Relative grip force
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Relative grip force
Tijdsspanne: After 8 days of intervention, and 3 months of enrollment
|
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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Christian Grefkes, MD, University Hospital Cologne
Studie record data
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Studie start (Werkelijk)
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Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
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Laatste update ingediend die voldeed aan QC-criteria
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Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- U1111-1204-6783
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