Stroke
Conditions
Brief summary
The present prospective, randomized, controlled, double-blinded trial investigates the effects of intermittent theta-burst stimulation (iTBS) during the early rehabilitation after stroke. Patients with hemipresis will receive either sham or real iTBS over their affected hemispheres before occupational therapy for 8 days. Motor recovery is assessed one day after the intervention phase and three months after enrollment.
Detailed description
To date, rehabilitation of stroke with hemiparesis mainly includes physiotherapy and occupational therapy. Yet, the majority of patients retain movement impairment relevant for activities of daily living. One explanation for this deficit is the insufficient recovery of connectivity between brain regions after stroke. It is possible to modulate this process by repetitive transcranial magnetic stimulation (rTMS) using the protocol of intermittent theta-burst stimulation (iTBS). Previous data indicate that modulation of the motor cortex with iTBS enhances the effects of subsequent motor training. The present study aims at investigating whether daily repetitive transcranial magnetic stimulation over 8 days combined with subsequent physiotherapy leads to better motor recovery, compared with physiotherapy after sham stimulation. In the first weeks and after three months, motor function, degree of disability and quality of life are examined in order to evaluate the effects of iTBS in the rehabilitation of stroke patients. Amendment (approved by the Ethics-Committee of the Medical Faculty of the University of Cologne, 20/12/2016): Specification of exclusion criteria. Amendment (approved by the Ethics-Committee of the Medical Faculty of the University of Cologne, 15/11/2018): Change of inclusion and exclusion criteria.
Interventions
DEVICEMagstim Super Rapid2 System, intermittent theta-burst-stimulation (iTBS) protocol
iTBS applied over ipsilesional M1
DEVICEMagstim Super Rapid2 System, sham-stimulation (in iTBS)
iTBS applied with tilted coil over parieto-occipital vertex
Sponsors
University of Cologne
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* written consent * age: 40-90 years * ischemic stroke * hemiparesis with impaired hand motor function
Exclusion criteria
* Subjects who are legally detained in an official institute (§20 MPG) * Participation in clinical trial within the last 12 weeks * 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 * Clinically manifest bilateral hemiparesis or infarcts in the primary motor cortex or along the tractus corticospinalis in the hemisphere ipsilateral to the hemiparesis * Pre-existing cerebral infarctions with hemiparesis or pre-existing cerebral infarctions in the primary motor cortex or along the tractus corticospinalis, excluding microangiopathic changes (e.g. clinically asymptomatic lacunae \<1cm) * Known brain lesion (surgical, traumatic) * Evidence for enhanced cerebral pressure * Severe cardial dysfunction * life expectancy \< 12 months * NIHSS Score \> 20 * Blood glucose imbalances resistant to treatment (\<50 mg/dl or \>300 mg/dl) * Elevated blood pressure resistant to treatment (RR \> 185/110mmHg) * Systemic Thrombolysis using r-tPA or thrombectomy within the last 24 hours before enrollment in study * Medication with benzodiazepines, high-potency antipsychotics or tricyclic antidepressants before hospitalization or long-term during hospitalization
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Relative grip force | 3 months after enrollment | grip force as measured with vigorimeter |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Motor function | after 8 days of intervention, and 3 months after enrollment | Action Research Arm Test, ARAT |
| Stroke severity | after 8 days of intervention, and 3 months after enrollment | National Instituts of Health Stroke Scale, NIHSS |
| Degree of disability | after 8 days of intervention, and 3 months after enrollment | modified Rankin Scale, mRS |
| Relative grip force | after 8 days of intervention, and 3 months after enrollment | grip force as measured with vigorimeter |
| Quality of life | after 8 days of intervention, and 3 months after enrollment | EuroQol 5D questionnaire, EQ-5D |
| Activities of daily living at admission and discharge in external rehabilitation facility | 3 months after enrollment | Barthel-Index (BI) scores as documented by external rehabilitation facility |
| Days of rehabilitation after intervention phase | 3 months after enrollment | Days of rehabilitation after intervention phase as documented by external rehabilitation facility |
| Motorcortex excitability | after 8 days of intervention, and 3 months after enrollment | Motor evoked potential induced by stimulation of the affected motor cortex, MEP |
Countries
Germany
Outcome results
None listed