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临床试验/NCT05198921
NCT05198921尚未招募不适用

The Effectiveness of Repetitive Transcranial Magnetic Stimulation for the Treatment of Spastic Diplegia Cerebral Palsy Based on the Gross Motor Function in School-aged Children: a Randomized Controlled Trial

Universitat de Lleida2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
30
试验地点
2
主要终点
Change in Gross Motor Function by the Gross Motor Function-66

研究概览

简要总结

Cerebral palsy describes a group of permanent disorders of the development of movement and posture, causing activity limitation that are attributed to non-progressive disturbances that occurred in the developing fetal or infant brain.

Nowadays, CP is not fully curable, and physiotherapy should be used in conjunction with other interventions such as oral drugs, botulinum toxin type A, continuous pump-administered intrathecal baclofen, orthopaedic surgery and selective dorsal rhizotomy. However, several systematic reviews conclude that there is low evidence that these invasive therapies are more effective than placebo.

Repetitive transcranial magnetic stimulation (rTMS) is a type of neuromodulatory technique through magnetic impulses. The effect of rTMS depends on the frequency of the emitted electromagnetic field; low frequencies (≤1 Hz) lead to an inhibition of neuronal electrical activity at the stimulation site, while high frequencies (≥3 Hz) cause neuronal depolarization.

The objective of the project is to evaluate the effectiveness of a repetitive Transcranial Magnetic Stimulation (rTMS) protocol, as an adjunct treatment to neurorehabilitation to improve gross motor function and quality of life in school-age children with spastic diplegia-type infantile cerebral palsy.

详细描述

Cerebral palsy describes a group of permanent disorders of the development of movement and posture, causing activity limitation that are attributed to non-progressive disturbances that occurred in the developing fetal or infant brain.

The reported worldwide prevalence rates of CP are approximately between 2 and 3 per 1000 live births. In Spain, it is estimated that between 2 and 2.5 per thousand born has cerebral palsy, that is, 1 per in 500 live births. In other words, in Spain there are 120,000 people with cerebral palsy.

The Spastic Diplegia form is the most common form with around 65-70 % of the CP children. It is characterized by gross motor difficulties, marked in the lower limb and partially affection noticeable in the upper limb.

Spasticity is defined as "disordered sensori-motor control, resulting from an upper motoneuron lesion, presenting as intermittent or sustained involuntary activation of muscles". Spasticity is a velocity-dependent motor disorder, characterized by an increased stretch reflex, resulting in immoderate muscle activation that causes a muscle hypertonia. The pathophysiology of spasticity is characterized, in general, by a deregulation of the motor pathways (mainly the corticospinal, reticulospinal, and the vestibulospinal tracts) running from the cerebral cortex, and brain stem to the spinal cord. In children who suffer from an early brain abnormality, spasticity is affected by the reorganization of supraspinal input and impaired motor maturation, causing a loss in descending inhibitory inputs and an increase of the excitability of gamma and alpha neurons.

NICE clinical guidance recommends the use of physiotherapy, as it provides an approach centred on how the current functional problems impact on the participation at home, school life and community. Nowadays, CP is not fully curable, and physiotherapy should be used in conjunction with other interventions such as oral drugs, botulinum toxin type A, continuous pump-administered intrathecal baclofen, orthopaedic surgery and selective dorsal rhizotomy. However, a recent Cochrane Systematic Review (CSR) concludes that there is low evidence that BoNT-A is more effective than placebo or a non-placebo control in children with CP. Another recent CSR determines that there is short-term evidence of the Intrathecal Baclofen therapy. Furthermore, there is not a CSR for orthopaedic surgery and selective dorsal rhizotomy.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
6 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Primary school children with diagnose of Spastic Diplegia CP
  • > 1 on Mas in hip flexors, adductors and tibialis anterior of both lower extremities.
  • Parents/legal guardians signed the Informed consent

排除标准

  • Severe mental retardation
  • Present epilepsy
  • Present any remedial surgery/medication
  • Less than 1 year post orthopaedic surgery
  • Less than 6 months post botulinum toxin type A injection
  • Present metallic implants
  • Present any comorbidity unfit for the study
  • Congenital disorders such as Down's syndrome, fragile-x syndrome or congenital anomalies

结局指标

主要结局

Change in Gross Motor Function by the Gross Motor Function-66

时间窗: baseline, one month, two months, three months and six months.

The GMFM is a standardized assessment instrument designed to measure change over time in gross motor function in cerebral palsy children. The GMFS-66 is an 66-item measure with five dimensions: lying and rolling, crawling/kneeling, standing and walking/running/jumping. Each GMFM item is graded on a 4-point scale. The magnitude of change that is considered clinically important for an individual child will vary and depend on the judgments made by the child, family, and therapist. It takes between 20-25 minutes to be completed. GMFM presents good longitudinal construct validity, the test - retest is high with a 0.99 ICC and researchers indicate that GMFM adequately measure change over time in gross motor function for children with CP.

次要结局

  • Change in Functional Strength by the Functional Strength Measure(baseline, one month, two months, three months and six months.)
  • Change in Quality of Life by the Cerebral Palsy Quality of Life-Child(baseline, one month, two months, three months and six months.)
  • Change in Spasticity by the Modified-Modified Ashworth Scale.(baseline, one month, two months, three months and six months.)
  • Change in Impact on family by the Revised Impact on Family questionnaire(baseline, one month, two months, three months and six months.)
  • Cortex excitability(Enrollment, 1st month, 2nd month, 3rd month and 4th month)

研究者

发起方
Universitat de Lleida
申办方类型
Other
责任方
Principal Investigator
主要研究者

Clàudia Arumí

Principal Investigator

Universitat de Lleida

研究点 (2)

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