Different frequencies of repetitive transcranial magnetic stimulation combined with local injection of botulinum toxin type A for post-stroke lower limb spasticity:study protocol for a prospective,single-center,non-randomized,controlled clinical trial

Yang Shao; Yang Yang; Yong-Xin Sun; Ai-Hua Xu

摘要

No definite consensus has currently been reached regarding the safety and efficacy of low-or high-frequency repetitive transcranial magnetic stimulation in the treatment of post-stroke muscle spasticity.The latest research indicates that when combined with local injections of botulinum toxin type A,it is more effective on post-stroke muscle spasticity than local injections of botulinum toxin type A alone.We designed a prospective,single-center,non-randomized,controlled clinical trial to investigate the safety and effica cy of different frequencies of repetitive transcranial magnetic stimulation combined with local injections of botulinum toxin type A in treating post-stroke lower limb muscle spasticity to determine an optimal therapeutic regimen.This trial will enroll 150 patients with post-stroke muscle spasticity admitted to the Department of Rehabilitation Medicine at the First Affiliated Hos pital of China Medical Unive rsity.All enrolled patients will undergo ro utine rehabilitation training and will be divided into five groups in-30 per group) according to the particular area of cerebral infa rction and treatment methods.G roup A:Patients with massive cerebral infarction will be given local injections of botulinum toxin type A and low-frequency(1 Hz)repetitive transcranial magnetic stimulation on the contralate ral side;G roup B:Patients with non-massive cerebral infarction will be given local injections of botulinum toxin type A and high-frequency(10-20 Hz) re petitive transcranial magnetic stimulation on the affected side;G roup C:Patients with massive/non-massive cerebral infarction will be given local injections of botulinum toxin type A;G roup D:Patients with massive cerebral infarction will be given low-frequency(1 Hz) repetitive transcranial magnetic stimulation on the contralate ral side;and G roup E:Patients with non-massive cerebral infa rction will be given high-frequency(10-20 Hz) repetitive transcranial magnetic stimulation on the affected side.The primary outcome measure of this trial is a modified Ashwo rth scale score from 1 day before treatment to 12 months after treatment.Secondary outcome measures include Fugl-M eyer Assessment of Lower Extremity,Visual Analogue Scale,modified Barthel index,and Berg Balance Scale scores for the same time as specified for primary outcome measures.The safety indicator is the incidence of adverse events at 3-12 months after treatment.We hope to draw a definite conclusion on whether there are diffe rences in the safety and efficacy of low-or high-frequency repetitive transcranial magnetic stimulation combined with botulinum toxin type A injections in the treatment of patients with post-stroke lower limb spasticity under strict grouping and standardized operation,thereby screening out the optimal therapeutic regimen.The study protocol was approved by the Medical Ethics Committee of the First Affiliated Hospital of China Medical University(approval No.[2021] 2021-333-3) on August 19,2021.The trial was registe red with the Chinese Clinical Trial Registry(Registration No.ChiCTR2100052180) on October 21,2021.The protocol version is 1.1.

Different frequencies of repetitive transcranial magnetic stimulation combined with local injection of botulinum toxin type A for post-stroke lower limb spasticity:study protocol for a prospective,single-center,non-randomized,controlled clinical trial

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