Efficacy and Safety of High-Dose TBS on Poststroke Upper Extremity Motor Impairment: A Randomized Controlled Trial

Stroke. 2024 Sep;55(9):2212-2220. doi: 10.1161/STROKEAHA.124.046597. Epub 2024 Jul 17.

Abstract

Background: Upper extremity (UE) motor function impairment is a major poststroke complication whose recovery remains one of the most challenging tasks in neurological rehabilitation. This study examined the efficacy and safety of the personalized neuroimaging-guided high-dose theta-burst stimulation (TBS) for poststroke UE motor function recovery.

Methods: Patients after stroke with UE motor impairment from a China rehabilitation center were randomly assigned to receive high-dose intermittent TBS (iTBS) to ipsilesional UE sensorimotor network, continuous TBS (cTBS) to contralesional UE sensorimotor network, or sham stimulation, along with conventional therapy for 3 weeks. The primary outcome was the score changes on the Fugl-Meyer assessment-UE from baseline to 1 and 3 weeks. The secondary outcomes included the response rate on Fugl-Meyer assessment-UE scores posttreatment (≥9-point improvement) and score changes in multidimensional scales measuring UE, lower extremity, and activities and participation.

Results: From June 2021 to June 2022, 45 participants were randomized and 43 were analyzed. The iTBS and continuous TBS groups showed significantly greater improvement in Fugl-Meyer assessment-UE (mean improvement, iTBS: 10.73 points; continuous TBS: 10.79 points) than the sham group (2.43 points) and exhibited significantly greater response rates on Fugl-Meyer assessment-UE (iTBS, 60.0%; continuous TBS, 64.3%) than the sham group (0.0%). The active groups consistently exhibited superior improvement on the other 2 UE assessments at week 3. However, only the iTBS group showed greater efficacy on 1 lower extremity assessment than the sham group at week 3. Both active groups showed significant improvements in activities and participation assessments.

Conclusions: The study provides evidence for the efficacy and safety of high-dose TBS in facilitating poststroke UE rehabilitation.

Registration: URL: www.chictr.org.cn; Unique identifier: ChiCTR2100047340.

Keywords: magnetic resonance imaging; neurological rehabilitation; stroke; transcranial magnetic stimulation; upper extremity.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Female
  • Humans
  • Male
  • Middle Aged
  • Recovery of Function* / physiology
  • Stroke Rehabilitation* / methods
  • Stroke* / complications
  • Stroke* / physiopathology
  • Transcranial Magnetic Stimulation* / methods
  • Treatment Outcome
  • Upper Extremity* / physiopathology

Associated data

  • ChiCTR/ChiCTR2100047340