Clinical trial NCT03456362: Cerebellar rTMS to Improve Gait Recovery
Official title: Promoting Motor Recovery in Patients With Stroke by Enhancing Cerebellar-cortical Plasticity: a Randomized Double Blinded Controlled Repetitive TMS Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Gait, Hemiplegic
Lead sponsor: I.R.C.C.S. Fondazione Santa Lucia
Sponsor class: OTHER
First posted: 2018-03-07
Enrollment: 40
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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:

* 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.

Primary outcomes:
measure: Berg Balance Scale (BBS) for gait and balance
timeFrame: Change from baseline at the end of three weeks treatment
Secondary outcomes:
measure: Fugl-Meyer Assessment (FMA) scale
timeFrame: Change from baseline at the end of three weeks treatment
measure: Barthel Index (BI)
timeFrame: Change from baseline at the end of three weeks treatment
measure: Neurophysiological assessment of cortical activity
timeFrame: Change from baseline at the end of three weeks treatment
measure: Gait analysis
timeFrame: Change from baseline at the end of three weeks treatment
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Santa Lucia Foundation
Study officials:
References:
citation: Koch G, Bonni S, Casula EP, Iosa M, Paolucci S, Pellicciari MC, Cinnera AM, Ponzo V, Maiella M, Picazio S, Sallustio F, Caltagirone C. Effect of Cerebellar Stimulation on Gait and Balance Recovery in Patients With Hemiparetic Stroke: A Randomized Clinical Trial. JAMA Neurol. 2019 Feb 1;76(2):170-178. doi: 10.1001/jamaneurol.2018.3639.