Promoting Motor Recovery in Patients With Stroke by Enhancing Cerebellar-cortical Plasticity: a Randomized Double Blinded Controlled Repetitive TMS Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Stroke
- Sponsor
- I.R.C.C.S. Fondazione Santa Lucia
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Berg Balance Scale (BBS) for gait and balance
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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
Investigators
Giacomo Koch
Head of Laboratory
I.R.C.C.S. Fondazione Santa Lucia
Eligibility Criteria
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
- •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.
Outcomes
Primary Outcomes
Berg Balance Scale (BBS) for gait and balance
Time Frame: Change from baseline at the end of three weeks treatment
Assessment of gait and balance functions
Secondary Outcomes
- Barthel Index (BI)(Change from baseline at the end of three weeks treatment)
- Neurophysiological assessment of cortical activity(Change from baseline at the end of three weeks treatment)
- Gait analysis(Change from baseline at the end of three weeks treatment)
- Fugl-Meyer Assessment (FMA) scale(Change from baseline at the end of three weeks treatment)