Stroke Clinical Trial
Official title:
Theta-Burst-Stimulation in Recurrent Stroke Recovery
Verified date | November 2019 |
Source | University Hospital of Cologne |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The present study aims at investigating the effects of intermittent theta-burst stimulation (iTBS) for motor recovery in recurrent stroke patients. Therefore a daily intervention of repetitive transcranial magnetic stimulation over 8 days combined with subsequent physiotherapy is compared to a control condition, sham stimulation combined with subsequent physiotherapy. 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.
Status | Active, not recruiting |
Enrollment | 60 |
Est. completion date | November 1, 2021 |
Est. primary completion date | November 1, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 90 Years |
Eligibility |
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 (ยง20 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 |
Country | Name | City | State |
---|---|---|---|
Germany | Christian Grefkles | Cologne |
Lead Sponsor | Collaborator |
---|---|
University Hospital of Cologne |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Relative grip force | grip force as measured with vigorimeter | 3 months after enrollment | |
Secondary | Relative grip force | Grip force as measured with vigorimeter | After 8 days of intervention, and 3 months of enrollment | |
Secondary | Motor function | Action Research Arm Test, ARAT | After 8 days of intervention, and 3 months of enrollment | |
Secondary | Motor function | 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 | |
Secondary | Stroke severity | 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 | |
Secondary | Degree of disability | 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 | |
Secondary | Motor cortex excitability/ Motor evoked potential | Motor evoked potential (MEP) induced by stimulation of the affected motor cortex | After 8 days of intervention, and 3 months of enrollment | |
Secondary | Motor cortex excitability/ Resting motor threshold | Resting motor threshold as measured by stimulation of the affected motor cortex, RMT | After 8 days of intervention, and 3 months of enrollment | |
Secondary | Motor cortex excitability/ Short-interval intracortical inhibition | 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 | |
Secondary | Motor cortex excitability/ Ipsilateral silent period | 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 | |
Secondary | Quality of life | EuroQol 5D questionnaire, EQ-5D | After 8 days of intervention, and 3 months of enrollment | |
Secondary | Activities of daily living at admission and discharge in external rehabilitation facility | 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 | |
Secondary | Days of rehabilitation after intervention phase | Days of rehabilitation after intervention phase as documented by external rehabilitation facility | 3 months after enrollment |
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