Cerebellar rTMS to Improve Gait Recovery

Study Overview
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Brief Summary
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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

Official Title
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Promoting Motor Recovery in Patients With Stroke by Enhancing Cerebellar-cortical Plasticity: a Randomized Double Blinded Controlled Repetitive TMS Trial

Conditions
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Stroke, Gait, Hemiplegic

Intervention / Treatment
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* Device: REPETITIVE TRANSCRANIAL MAGNETIC STIMULATION


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cerebellar iTBS<br>Intermittent theta burst stimulation applied immediately before the daily physical therapy session for a period of three weeks. | Device: REPETITIVE TRANSCRANIAL MAGNETIC STIMULATION<br>* 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<br>|
| Sham Comparator: Sham iTBS<br>Sham intermittent theta burst stimulation applied immediately before the daily physical therapy session for a period of three weeks. | Device: REPETITIVE TRANSCRANIAL MAGNETIC STIMULATION<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Berg Balance Scale (BBS) for gait and balance | Assessment of gait and balance functions | Change from baseline at the end of three weeks treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fugl-Meyer Assessment (FMA) scale | Assessment of motor functions | Change from baseline at the end of three weeks treatment | 
| Barthel Index (BI) | Assessment of functional abilities | Change from baseline at the end of three weeks treatment | 
| Neurophysiological assessment of cortical activity | evaluation of cortical activity by means of TMS in combination with EEG | Change from baseline at the end of three weeks treatment | 
| Gait analysis | evaluation of locomotion | Change from baseline at the end of three weeks treatment |