Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
60 participants
INTERVENTIONAL
2018-01-11
2021-11-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
TRIPLE
Study Groups
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Real-iTBS
Magstim Super Rapid2 System
Intermittent theta-burst-stimulation (iTBS) protocol
Sham-iTBS
Magstim Super Rapid2 System
Sham stimulation
Interventions
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Magstim Super Rapid2 System
Intermittent theta-burst-stimulation (iTBS) protocol
Magstim Super Rapid2 System
Sham stimulation
Eligibility Criteria
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Inclusion Criteria
* age: 40-90 years
* recurrent stroke
* hemiparesis with impaired hand motor function
Exclusion Criteria
* 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
40 Years
90 Years
ALL
No
Sponsors
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University Hospital of Cologne
OTHER
Responsible Party
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Christian Grefkes
Principal Investigator, Professor
Principal Investigators
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Christian Grefkes, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital Cologne
Locations
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Christian Grefkles
Cologne, , Germany
Countries
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Other Identifiers
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U1111-1204-6783
Identifier Type: -
Identifier Source: org_study_id
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