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间歇性θ波爆发刺激治疗脊髓损伤上肢功能障碍和痉挛:单盲随机可行性研究

Intermittent theta-burst stimulation for upper-limb dysfunction and spasticity in spinal cord injury: a single-blind randomized feasibility study.

作者信息

Gharooni Aref-Ali, Nair Krishnan Padmakumari Sivaraman, Hawkins Debby, Scivill Ian, Hind Daniel, Hariharan Ram

机构信息

Princess Royal Spinal Injuries Centre, Sheffield Teaching Hospitals, Sheffield, UK.

Clinical Trials Research Unit, University of Sheffield, Regent Court, 30 Regent Court, Sheffield, S1 4DA, UK.

出版信息

Spinal Cord. 2018 Aug;56(8):762-768. doi: 10.1038/s41393-018-0152-5. Epub 2018 Jun 12.


DOI:10.1038/s41393-018-0152-5
PMID:29895874
Abstract

STUDY DESIGN: Single-blind, sham-controlled, crossover randomized feasibility study OBJECTIVES: (1) Assess the feasibility of a full-scale trial of intermittent theta-burst stimulation (iTBS) for upper-limb sensorimotor dysfunction following spinal cord injury (SCI). (2) Determine the safety and tolerability of iTBS over primary motor cortex on upper-limb function in people with spinal cord injury (SCI). SETTING: Large Tertiary Spinal Injuries Centre METHODS: Participants with incomplete SCI, suffering with upper-limb spasticity were recruited and randomized to receive active/sham iTBS over the hand representation of the primary motor cortex. The intervention was delivered in 10 sessions over a 2-week period, followed by a 2-week washout, before being crossed over to receive the alternative intervention for the same number of sessions. Feasibility was assessed by pre-specified criteria which included recruitment rate of 3 participants per month, 10 completed interventions and 10 complete data sets for 15 recruited participants with no serious adverse events. Secondary outcomes included preliminary data collection for spasticity, pain and sensorimotor function. RESULTS: Twelve participants were recruited over 10 weeks (i.e., 4.8 per month), with 11 randomized and 10 completing the intervention protocol with no serious adverse events. Eight complete data sets were obtained as two participants failed to attend follow-up. Data from 10 participants were analyzed, with one early dropout due to an unrelated adverse event. CONCLUSIONS: It is safe and feasible to conduct a full-scale trial. Whilst iTBS has shown promising results, further research optimizing the intervention is required to improve anticipated clinical efficacy.

摘要

研究设计:单盲、假刺激对照、交叉随机可行性研究 目的:(1)评估对脊髓损伤(SCI)后上肢感觉运动功能障碍进行间歇性theta波爆发刺激(iTBS)全面试验的可行性。(2)确定对脊髓损伤(SCI)患者的初级运动皮层进行iTBS对上肢功能的安全性和耐受性。 地点:大型三级脊髓损伤中心 方法:招募患有上肢痉挛的不完全性SCI参与者,并随机分配接受对初级运动皮层手部代表区的主动/假iTBS。干预在2周内进行10次,随后有2周的洗脱期,然后交叉接受相同次数的替代干预。通过预先指定的标准评估可行性,这些标准包括每月招募3名参与者、10次完成的干预以及为15名招募的参与者获取10套完整数据集且无严重不良事件。次要结果包括收集关于痉挛、疼痛和感觉运动功能的初步数据。 结果:在10周内招募了12名参与者(即每月4.8名),11名被随机分组,10名完成了干预方案且无严重不良事件。由于两名参与者未参加随访,获得了8套完整数据集。分析了10名参与者的数据,其中一名因无关不良事件提前退出。 结论:进行全面试验是安全可行的。虽然iTBS已显示出有前景的结果,但需要进一步研究优化干预措施以提高预期的临床疗效。

相似文献

[1]
Intermittent theta-burst stimulation for upper-limb dysfunction and spasticity in spinal cord injury: a single-blind randomized feasibility study.

Spinal Cord. 2018-8

[2]
Effects of intermittent theta burst stimulation on spasticity after spinal cord injury.

Restor Neurol Neurosci. 2017

[3]
Effects of high-frequency transcranial magnetic stimulation on functional performance in individuals with incomplete spinal cord injury: study protocol for a randomized controlled trial.

Trials. 2017-11-6

[4]
Effect of Intermittent Theta Burst Stimulation Dual-Target Stimulation on Lower Limb Function in Patients with Incomplete Spinal Cord Injury: A Randomized, Single-Blind, Sham-Controlled Study.

World Neurosurg. 2024-10

[5]
Effects of high-frequency repetitive transcranial magnetic stimulation on motor and gait improvement in incomplete spinal cord injury patients.

Neurorehabil Neural Repair. 2013-1-15

[6]
Effects of priming intermittent theta burst stimulation on upper limb motor recovery after stroke: study protocol for a proof-of-concept randomised controlled trial.

BMJ Open. 2020-3-8

[7]
Effects of intermittent theta burst stimulation on spasticity in patients with multiple sclerosis.

Eur J Neurol. 2009-10-23

[8]
Improvement of spasticity following intermittent theta burst stimulation in multiple sclerosis is associated with modulation of resting-state functional connectivity of the primary motor cortices.

Mult Scler. 2016-8-1

[9]
Intermittent theta burst stimulation enhances upper limb motor function in patients with chronic stroke: a pilot randomized controlled trial.

BMC Neurol. 2019-4-25

[10]
Primed Physical Therapy Enhances Recovery of Upper Limb Function in Chronic Stroke Patients.

Neurorehabil Neural Repair. 2016-5

引用本文的文献

[1]
Repetitive transcranial magnetic stimulation for enhancing motor function after spinal cord injury: a narrative review.

Front Neurol. 2025-7-2

[2]
Efficacy of Excitatory iTBS on Lower Limb Recovery in iSCI Patients.

Global Spine J. 2025-6-3

[3]
nTMS in spinal cord injury: Current evidence, challenges and a future direction.

Brain Spine. 2025-3-14

[4]
Efficacy of neuromodulation and rehabilitation approaches on pain relief in patients with spinal cord injury: a systematic review and meta-analysis.

Neurol Sci. 2025-3-11

[5]
Global research hotspots and trends of theta burst stimulation from 2004 to 2023: a bibliometric analysis.

Front Neurol. 2024-12-10

[6]
Noninvasive Electromagnetic Neuromodulation of the Central and Peripheral Nervous System for Upper-Limb Motor Strength and Functionality in Individuals with Cervical Spinal Cord Injury: A Systematic Review and Meta-Analysis.

Sensors (Basel). 2024-7-19

[7]
Cortical intermittent theta burst stimulation on gait pathomechanics and urinary tract dysfunction in incomplete spinal cord injury patients: Protocol for a randomized controlled trial.

MethodsX. 2024-6-25

[8]
Comparison of intermittent theta burst stimulation and high-frequency repetitive transcranial magnetic stimulation on spinal cord injury-related neuropathic pain: A sham-controlled study.

J Spinal Cord Med. 2025-3

[9]
The effectiveness of intermittent theta burst stimulation for upper limb motor recovery after stroke: a systematic review and meta-analysis of randomized controlled trials.

Front Neurosci. 2023-10-12

[10]
The effect of high-frequency repetitive transcranial magnetic stimulation on motor recovery and gait parameters in chronic incomplete spinal cord injury: A randomized-controlled study.

Turk J Phys Med Rehabil. 2023-6-6

本文引用的文献

[1]
Harnessing neural activity to promote repair of the damaged corticospinal system after spinal cord injury.

Neural Regen Res. 2016-9

[2]
Systematic Review of Pharmacologic Treatments of Pain After Spinal Cord Injury: An Update.

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J Physiother. 2016-1

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World J Orthop. 2015-1-18

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J Neurol Phys Ther. 2015-1

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Pharm Stat. 2014

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Inter- and Intra-individual variability following intermittent theta burst stimulation: implications for rehabilitation and recovery.

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[8]
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Clin Neurophysiol. 2013-8-28

[9]
Effect of single-session repetitive transcranial magnetic stimulation applied over the hand versus leg motor area on pain after spinal cord injury.

Neurorehabil Neural Repair. 2013-4-11

[10]
Distribution-based estimates of clinically significant changes in the International Standards for Neurological Classification of Spinal Cord Injury motor and sensory scores.

Eur J Phys Rehabil Med. 2013-3-13

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