brain stimulation for arm recovery after stroke 2

Conditions: Stroke

Summary: rationale: every year, about 40,000 people in the netherlands have a stroke. after the initial admission to the hospital, about 15% of stroke survivors is admitted to a rehabilitation center because of remaining disabilities. three out of four of these patients have upper limb dysfunction, hampering activities of daily living. upper limb function plays a critical role in the performance of most daily life activities. in our phase ii trial b-stars, continuous theta burst stimulation (ctbs) treatment led to an absolute additional recovery of upper limb function of 17%, as measured with the action research arm test (arat) score three months after stroke. this improvement exceeds the minimal clinically important difference of 10%. ctbs treatment also resulted in a significant improvement in measures of activities and participation (of similar magnitude) and a reduction in the mean length of stay at the rehabilitation center by 18 days. objective: to assess the effectiveness and cost effectiveness of ctbs treatment in promoting upper limb recovery after stroke in patients admitted to a rehabilitation center. study design: a phase iii, multi-center, double-blind, randomized, sham-controlled, clinical trial. study population: 454 patients aged 18 years or older with a first-ever ischemic stroke or intracerebral hemorrhage and a unilateral arm paresis, defined by a motricity index between 9 and 99, in whom ctbs treatment can be started within 3 weeks after stroke onset. intervention: 10 daily sessions of ctbs delivered over the contralesional primary motor cortex during a period of 2 weeks, delivered immediately before regular care physical therapy of the affected upper limb. main study parameters/endpoints: the primary endpoint will be the score on the upper extremity section of the fugl-meyer assessment (fm-ue) at 90 days after stroke. secondary endpoints will include the score on the fm-ue at one year and the scores on the action research arm test, nine hole peg test, stroke impact scale, euroqol 5 dimensions and modified rankin scale at 90 days and one year after stroke


Eligibility criteria:
inclusion criteria: * age, 18 years or older * first-ever unilateral ischemic stroke or intracerebral hemorrhage in a cerebral hemisphere or the brainstem; * unilateral upper limb paresis with a motricity index between 9 and 99; * possibility to start ctbs treatment within 21 days after stroke onset; * signed informed consent. exclusion criteria: * upper limb paresis prior to stroke onset; * absolute contra-indication to tms * magnetic sensitive objects implanted in the head or neck area (e.g. cochlear implants, implanted neurostimulator, pacemaker or defibrillator, metal splinters, metal fragments or metal clips); * history of epilepsy; * other contra-indications that may potentially be harmful as determined by the treating rehabilitation physician; * severe impairments that can impede study participation as determined by the treating rehabilitation physician (i.e. extreme fatigue, severe communication deficits); * life expectancy shorter than one year.

Keywords: stroke transcranial magnetic stimulation continuous theta burst stimulation upper limb recovery tms ctbs