Cerebellar rTMS to Improve Gait Recovery

Completed

Phase N/A Results N/A

Trial Description

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

Conditions

Interventions

  • Repetitive Transcranial Magnetic Stimulation Other
    Other Names: rTMS
    Intervention Desc: 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
    ARM 1: Kind: Experimental
    Label: Cerebellar iTBS
    Description: Intermittent theta burst stimulation applied immediately before the daily physical therapy session for a period of three weeks.
    ARM 2: Kind: Experimental
    Label: Sham iTBS
    Description: Sham intermittent theta burst stimulation applied immediately before the daily physical therapy session for a period of three weeks.

Outcomes

Type Measure Time Frame Safety Issue
Primary Berg Balance Scale (BBS) for gait and balance Change from baseline at the end of three weeks treatment
Secondary Fugl-Meyer Assessment (FMA) scale Change from baseline at the end of three weeks treatment
Secondary Barthel Index (BI) Change from baseline at the end of three weeks treatment
Secondary Neurophysiological assessment of cortical activity Change from baseline at the end of three weeks treatment
Secondary Gait analysis Change from baseline at the end of three weeks treatment

Sponsors