Cerebellar rTMS to Improve Gait Recovery

I.R.C.C.S. Fondazione Santa Lucia

Status

Completed

Conditions

Stroke

Gait, Hemiplegic

Treatments

Device: REPETITIVE TRANSCRANIAL MAGNETIC STIMULATION

Study type

Interventional

Funder types

Other

Identifiers

NCT03456362

RF-2011-02349953

Details and patient eligibility

About

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

Enrollment

40 patients

Sex

All

Ages

30 to 80 years old

Volunteers

No Healthy Volunteers

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.