Gait, Hemiplegic, Stroke
Conditions
Brief summary
The cerebellum is known to be strongly implicated in the functional reorganization of motor networks in stroke patients, especially for gait an balance functions. Repetitive transcranial magnetic stimulation of the cerebellum can be used to enhance these adaptive processes in stroke recovery. In this randomized, double blind, sham-controlled trial we aim to investigate the efficacy and safety of cerebellar intermittent theta burst stimulation coupled with intensive physical therapy in promoting gait recovery in hemiparetic patients due to recent stroke in the territory of the contralateral middle cerebral artery
Interventions
DEVICEREPETITIVE TRANSCRANIAL MAGNETIC STIMULATION
theta burst stimulation (TBS) is a novel form of repetitive transcranial magnetic stimulation that mimics protocols inducing long-term potentiation (LTP) or long-term depression (LTD) in animal models. Whereas continuous TBS (cTBS) induces long-lasting inhibition of cortical areas, iTBS exerts the opposite effect, increasing cerebellar excitability
Sponsors
I.R.C.C.S. Fondazione Santa Lucia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
30 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* First ever-chronic ischemic stroke, i.e. at least 6 months after the stroke event, * Left or right subcortical or cortical lesion of the middle cerebral artery with medium-severity stroke NHISS \<15 (All lesions must be documented by magnetic resonance imaging (T1- and T2-weighted images; 1.5T, GE scanners) * No contraindication to brain MRI * MEP recordable in order to evaluate the resting motor threshold (RMT)
Exclusion criteria
* Epilepsy * Severe general impairment or concomitant diseases (tumors, etc.) * Age\> 80 years * Infections in progress * Patients with neurological diseases beyond stroke or with neuropsychiatric disorders or with neuropsychological disorders that could potentially compromise informed consent or compliance during the study. * Treatment with benzodiazepines, baclofen, antidepressants, clonidine, beta blockers and other potentially interfering drug treatments on plasticity phenomena.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Berg Balance Scale (BBS) for gait and balance | Change from baseline at the end of three weeks treatment | Assessment of gait and balance functions |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fugl-Meyer Assessment (FMA) scale | Change from baseline at the end of three weeks treatment | Assessment of motor functions |
| Barthel Index (BI) | Change from baseline at the end of three weeks treatment | Assessment of functional abilities |
| Neurophysiological assessment of cortical activity | Change from baseline at the end of three weeks treatment | evaluation of cortical activity by means of TMS in combination with EEG |
| Gait analysis | Change from baseline at the end of three weeks treatment | evaluation of locomotion |
Countries
Italy
Outcome results
None listed