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Original Investigation
November 26, 2018

Effect of Cerebellar Stimulation on Gait and Balance Recovery in Patients With Hemiparetic StrokeA Randomized Clinical Trial

Author Affiliations
  • 1Non Invasive Brain Stimulation Unit/Department of Behavioral and Clinical Neurology, Santa Lucia Foundation IRCCS, Rome, Italy
  • 2Stroke Unit, Department of Neuroscience, Tor Vergata Policlinic, Rome, Italy
  • 3Clinical Laboratory of Experimental Neurorehabilitation, Santa Lucia Foundation IRCCS, Rome, Italy
  • 4Department of Systems Medicine, University of Rome Tor Vergata, Rome, Italy
JAMA Neurol. Published online November 26, 2018. doi:10.1001/jamaneurol.2018.3639
Key Points

Question  Is it possible to enhance gait and balance recovery in patients with hemiparesis due to stroke by using noninvasive cerebellar stimulation?

Findings  In this randomized clinical trial that included 34 patients with ischemic stroke, cerebellar magnetic stimulation coupled with physiotherapy vs sham stimulation improved gait and balance functions by promoting cerebello-cortical plasticity.

Meaning  Cerebellar magnetic stimulation may be an effective, low-cost, and noninvasive strategy to promote gait and balance recovery in patients with stroke.

Abstract

Importance  Gait and balance impairment is associated with poorer functional recovery after stroke. The cerebellum is known to be strongly implicated in the functional reorganization of motor networks in patients with stroke, especially for gait and balance functions.

Objective  To determine whether cerebellar intermittent θ-burst stimulation (CRB-iTBS) can improve balance and gait functions in patients with hemiparesis due to stroke.

Design, Setting, Participants  This randomized, double-blind, sham-controlled phase IIa trial investigated efficacy and safety of a 3-week treatment of CRB-iTBS coupled with physiotherapy in promoting gait and balance recovery in patients with stroke. Thirty-six patients with consecutive ischemic chronic stroke in the territory of the contralateral middle cerebral artery with hemiparesis were recruited from a neuro-rehabilitation hospital. Participants were screened and enrolled from March 2013 to June 2017. Intention-to-treat analysis was performed.

Interventions  Patients were randomly assigned to treatment with CRB-iTBS or sham iTBS applied over the cerebellar hemisphere ipsilateral to the affected body side immediately before physiotherapy daily during 3 weeks.

Main Outcomes and Measures  The primary outcome was the between-group difference in change from baseline in the Berg Balance Scale. Secondary exploratory measures included the between-group difference in change from baseline in Fugl-Meyer Assessment scale, Barthel Index, and locomotion assessment with gait analysis and cortical activity measured by transcranial magnetic stimulation in combination with electroencephalogram.

Results  A total of 34 patients (mean [SD] age, 64 [11.3] years; 13 women [38.2%]) completed the study. Patients treated with CRB-iTBS, but not with sham iTBS, showed an improvement of gait and balance functions, as revealed by a pronounced increase in the mean (SE) Berg Balance Scale score (baseline: 34.5 [3.4]; 3 weeks after treatment: 43.4 [2.6]; 3 weeks after the end of treatment: 47.5 [1.8]; P < .001). No overall treatment-associated differences were noted in the Fugl-Meyer Assessment (mean [SE], baseline: 163.8 [6.8]; 3 weeks after treatment: 171.1 [7.2]; 3 weeks after the end of treatment: 173.5 [6.9]; P > .05) and Barthel Index scores (mean [SE], baseline: 71.1 [4.92]; 3 weeks after treatment: 88.8 [2.1]; 3 weeks after the end of treatment: 92.2 [2.4]; P > .05). Patients treated with CRB-iTBS, but not sham iTBS, showed a reduction of step width at the gait analysis (mean [SE], baseline: 16.8 [4.8] cm; 3 weeks after treatment: 14.3 [6.2] cm; P < .05) and an increase of neural activity over the posterior parietal cortex.

Conclusions and Relevance  Cerebellar intermittent θ-burst stimulation promotes gait and balance recovery in patients with stroke by acting on cerebello-cortical plasticity. These results are important to increase the level of independent walking and reduce the risk of falling.

Trial Registration  ClinicalTrials.gov Identifier: NCT03456362.

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