An interventional study of REPETITIVE TRANSCRANIAL MAGNETIC STIMULATION in Stroke and Gait, Hemiplegic, sponsored by I.R.C.C.S. Fondazione Santa Lucia. Completed at 1 site in Italy. Open to participants aged 30 Years to 80 Years. Per ClinicalTrials.gov, last updated 2018-03-07.
Sponsored by I.R.C.C.S. Fondazione Santa Lucia · Not applicable, Interventional, and Treatment
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
Exclusion Criteria:
Intermittent theta burst stimulation applied immediately before the daily physical therapy session for a period of three weeks.
Device: REPETITIVE TRANSCRANIAL MAGNETIC STIMULATION
Sham intermittent theta burst stimulation applied immediately before the daily physical therapy session for a period of three weeks.
Device: REPETITIVE TRANSCRANIAL MAGNETIC STIMULATION
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
Berg Balance Scale (BBS) for gait and balance
Assessment of gait and balance functions
Time frame: Change from baseline at the end of three weeks treatment
Fugl-Meyer Assessment (FMA) scale
Assessment of motor functions
Time frame: Change from baseline at the end of three weeks treatment
Barthel Index (BI)
Assessment of functional abilities
Time frame: 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
Time frame: Change from baseline at the end of three weeks treatment
Gait analysis
evaluation of locomotion
Time frame: Change from baseline at the end of three weeks treatment
Plan to share: Undecided
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I.R.C.C.S. Fondazione Santa Lucia