Clinical trial NCT03337867: Theta-Burst-Stimulation in Recurrent Stroke Recovery
Official title: Theta-Burst-Stimulation in Recurrent Stroke Recovery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Stroke
Neurorehabilitation
Keywords: Recurrent stroke
Stroke
Transcranial Magnetic Stimulation
Theta-Burst-Stimulation
Lead sponsor: University Hospital of Cologne
Sponsor class: OTHER
First posted: 2017-11-09
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Relative grip force
timeFrame: 3 months after enrollment
Secondary outcomes:
measure: Relative grip force
timeFrame: After 8 days of intervention, and 3 months of enrollment
measure: Motor function
timeFrame: After 8 days of intervention, and 3 months of enrollment
measure: Motor function
timeFrame: After 8 days of intervention, and 3 months of enrollment
measure: Stroke severity
timeFrame: After 8 days of intervention, and 3 months of enrollment
measure: Degree of disability
timeFrame: After 8 days of intervention, and 3 months of enrollment
measure: Motor cortex excitability/ Motor evoked potential
timeFrame: After 8 days of intervention, and 3 months of enrollment
measure: Motor cortex excitability/ Resting motor threshold
timeFrame: After 8 days of intervention, and 3 months of enrollment
measure: Motor cortex excitability/ Short-interval intracortical inhibition
timeFrame: After 8 days of intervention, and 3 months of enrollment
measure: Motor cortex excitability/ Ipsilateral silent period
timeFrame: After 8 days of intervention, and 3 months of enrollment
measure: Quality of life
timeFrame: After 8 days of intervention, and 3 months of enrollment
measure: Activities of daily living at admission and discharge in external rehabilitation facility
timeFrame: After 8 days of intervention, and 3 months of enrollment
measure: Days of rehabilitation after intervention phase
timeFrame: 3 months after enrollment
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: Christian Grefkles
Study officials:
affiliation: University Hospital Cologne
name: Christian Grefkes, MD
role: PRINCIPAL_INVESTIGATOR
References: