Cerebellar rTMS to Improve Gait Recovery

Not Applicable

Completed

• Conditions: Gait, Hemiplegic; Stroke
• Interventions: Device: REPETITIVE TRANSCRANIAL MAGNETIC STIMULATION

• Registration Number: NCT03456362
• Lead Sponsor: I.R.C.C.S. Fondazione Santa Lucia

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

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03-01
• Primary Completion: 2017-06-01
• Study Completion: 2017-10-01
• Study First Submitted: 2018-02-19
• Status Verified: 2018-03
• Study First Submitted QC: 2018-03-05
• Last Update Submitted: 2018-03-05
• Study First Posted: 2018-03-07
• Last Update Posted: 2018-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cerebellar iTBS	REPETITIVE TRANSCRANIAL MAGNETIC STIMULATION	Intermittent theta burst stimulation applied immediately before the daily physical therapy session for a period of three weeks.
Sham iTBS	REPETITIVE TRANSCRANIAL MAGNETIC STIMULATION	Sham intermittent theta burst stimulation applied immediately before the daily physical therapy session for a period of three weeks.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
Fugl-Meyer Assessment (FMA) scale	Change from baseline at the end of three weeks treatment	Assessment of motor functions

Trial Locations

Locations (1)

Santa Lucia Foundation; 🇮🇹 Rome, Italy