跳至主要内容
临床试验/NCT07488429
NCT07488429招募中不适用

Impact of rTMS Combined With Neurorehabilitation on Lower Extremity Motor Function and Spasticity in Children With Spastic Diplegic Cerebral Palsy

Ankara City Hospital Bilkent1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年5月5日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
20
试验地点
1
主要终点
Gross Motor Function Measure-88 (GMFM-88) - Dimension D and E

研究概览

简要总结

Cerebral palsy (CP) is widely recognized as the most prevalent cause of lifelong physical disability emerging in childhood across most global populations. While international data typically reports a prevalence ranging from 1.5 to 2.5 per 1,000 live births, in our specific national context, this rate is notably higher, reaching 4.4 per 1,000. CP is defined as a heterogeneous group of permanent disorders that fundamentally disrupt the development of movement and posture. These disruptions lead to significant activity limitations and are attributed to non-progressive disturbances occurring in the developing fetal or infant brain. Beyond primary motor impairments, CP is frequently characterized by a complex constellation of associated symptoms, including sensory and perceptual deficits, cognitive impairments, communication difficulties, behavioral challenges, epilepsy, and secondary musculoskeletal complications that develop over time.Among the various clinical presentations, diplegic CP stands out as the most common subtype of spastic CP, with prematurity identified as the leading etiological factor. In children diagnosed with spastic diplegia, all four extremities are typically involved; however, the clinical hallmark of this subtype is that the lower extremities are significantly more affected than the upper extremities. Despite this lower-body dominance, a loss of fine motor skills is frequently observed in the upper extremities as well. Most children with spastic diplegia face the risk of becoming significantly disabled due to these combined symptoms, a situation that exerts a profound and lasting impact on the quality of life for both the child and their entire family.This complex clinical picture underscores the critical importance of implementing a comprehensive and multidisciplinary CP rehabilitation program. Such programs must be initiated as early as possible, tailored to the child's specific age and functional status, and maintained throughout their entire lifespan. The planning of CP rehabilitation requires a highly individualized approach based on the unique needs of each patient. The ultimate and primary goal of these interventions is to facilitate the child's full participation in social life while maintaining the minimum possible level of physical and functional disability.In contemporary CP rehabilitation, a wide array of therapeutic modalities is employed. These include neurophysiological exercises, conventional physical therapy, gait training, orthotics, assistive devices, and pharmacological spasticity management. Furthermore, occupational therapy, cognitive rehabilitation, speech and swallowing therapy, hydrotherapy, and advanced robotic treatments-such as virtual reality applications and balance-training devices-are integrated into the patient's care plan. Functional Electrical Stimulation (FES), including specialized applications like FES cycling, and visual rehabilitation are also prescribed according to individual requirements.In addition to these traditional methods, recent research in pediatric neurology has increasingly focused on the efficacy of Non-Invasive Brain Stimulation (NIBS) for various pediatric neurological disorders. For any therapeutic modality to demonstrate a truly effective and long-lasting impact, it must influence the brain's neuroplasticity over the long term. Theoretically, treatment methods that act directly on the cerebral cortex or specific neuronal populations may support nervous system development and correct dysfunction more effectively than traditional "bottom-up" approaches. While traditional methods rely on remodeling the central nervous system through peripheral organ stimulation, NIBS offers a "top-down" regulatory mechanism.One of the most promising novel diagnostic and therapeutic options in CP management is Transcranial Magnetic Stimulation (TMS), a specific form of NIBS that has shown effectiveness in improving clinical outcomes for children. The fundamental objective of TMS is to stimulate neurons in targeted cortical regions and their associated networks through an intact skull using a magnetic coil. This technology modulates neuronal activity patterns: it achieves an inhibitory effect when applied at low frequencies (1-5 Hz) or an excitatory effect at high frequencies (5-20 Hz), thereby aiming to restore a healthy neuronal balance in the brain.Extensive clinical studies indicate that repetitive TMS (rTMS) can significantly improve motor function, reduce spasticity, enhance balance control, and even improve speech functions in CP patients. Although the relatively limited number of pediatric studies sometimes leads to hesitation regarding safety, current clinical evidence suggests that rTMS is a safe and well-tolerated intervention for children with CP. No serious adverse events have been reported in pediatric rTMS trials to date. Rare side effects, when they occur, are typically transient and mild, including minor headaches, neck pain, scalp

详细描述

1. Aim and Significance of the Research Cerebral palsy (CP) is the most common cause of lifelong physical disability observed in childhood in most countries, with a prevalence ranging from 1.5 to 2.5 per 1,000 live births; in our country, this rate is 4.4.

CP is a group of permanent disorders affecting the development of movement and posture, leading to activity limitation, attributed to non-progressive disturbances that occurred in the developing fetal or infant brain. Motor disorders in CP are frequently accompanied by sensory and perceptual problems, cognitive impairments, communication and behavioral issues, epilepsy, and secondary musculoskeletal problems.

Diplegic CP is the most common subtype of spastic CP, with prematurity identified as the primary etiology. In children with spastic diplegia, all four extremities are involved; however, the lower extremities are significantly more affected than the upper extremities. A loss of fine motor skills is frequently observed in the upper extremities.

Most children with spastic diplegia may become significantly disabled due to these symptoms, which profoundly impacts the lives of both the child and the entire family. This situation underscores the importance of comprehensive CP rehabilitation. The rehabilitation program should be initiated as early as possible, considering the child's age and functional status, and must continue throughout their lifetime. When planning CP rehabilitation, an individualized program should be developed based on the child's specific needs. Our primary goal in CP rehabilitation should be to ensure that children participate in social life with the minimum possible level of disability.

In CP rehabilitation, therapeutic modalities such as neurophysiological exercises, conventional exercises, gait training, orthotics, the use of assistive devices, spasticity management, occupational therapy, cognitive rehabilitation, speech and swallowing therapy, hydrotherapy, robotic treatments (virtual reality applications, balance devices, etc.), Functional Electrical Stimulation (FES) applications (e.g., FES cycling), and visual rehabilitation are prescribed according to the patient's condition and needs. Alongside these modalities, research in pediatric neurology has focused on the efficacy of Non-Invasive Brain Stimulation (NIBS) for treating various pediatric neurological disorders. For any therapeutic modality to demonstrate an effective and long-lasting therapeutic impact, it must possess a function that influences the brain's neuroplasticity in the long term. Theoretically, a treatment method that acts directly on the cerebral cortex or neurons may support the development of the nervous system and correct dysfunction more effectively than the traditional bottom-up regulation and remodeling of the central nervous system through peripheral organ stimulation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
5 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of Spastic Diplegic Cerebral Palsy.
  • Between 5 and 18 years of age.
  • Cooperative and oriented (capable of following commands).
  • Gross Motor Function Classification System (GMFCS) Level II or III.

排除标准

  • Poor general health status.
  • Children with severe comorbid conditions (e.g., total or partial blindness, severe lower extremity deformities, etc.).
  • Diagnosis of epilepsy.
  • History of seizures.
  • Presence of a cardiac pacemaker.
  • Presence of metal implants (specifically in the cranial and cervical regions).
  • Open wounds or infections at the application site.
  • History of botulinum toxin injection or surgical intervention within the 6 months prior to study enrollment.
  • History of Selective Posterior Rhizotomy (SPR) surgery.

研究组 & 干预措施

rTMS + Comprehensive Neurological Rehabilitation

Experimental

Participants receive 20 sessions of 5 Hz rTMS (1000 pulses/session, 5 days/week for 4 weeks) followed by a daily neurological rehabilitation program (45 min physiotherapy, twice-weekly OT, thrice-weekly child development sessions, and 10 sessions of robotic gait training)

干预措施: TMS (Device)

Comprehensive Neurological Rehabilitation Alone

No Intervention

Participants receive the daily neurological rehabilitation program alone (45 min physiotherapy, twice-weekly OT, thrice-weekly child development sessions, and 10 sessions of robotic gait training) without rTMS

结局指标

主要结局

Gross Motor Function Measure-88 (GMFM-88) - Dimension D and E

时间窗: Patients included in the study will be evaluated at baseline (pre-treatment), immediately after the intervention (post-treatment), and at a 12-week follow-up from the start of treatment.

This is a widely used classification system in CP-related research. It is a valid and reliable scale for classifying the severity of gross motor function limitations in children with CP. It defines the major functional characteristics of children with CP by dividing them into four age groups: under 2 years, 2-4 years, 4-6 years, and 6-12 years. Children at Level I are the most independent in motor functions, while children at Level V are the most dependent.

Modified Ashworth Scale (MAS)

时间窗: Patients included in the study will be evaluated at baseline (pre-treatment), immediately after the intervention (post-treatment), and at a 12-week follow-up from the start of treatment.

The Modified Ashworth Scale (MAS) is used to assess the severity of spasticity. The joint is moved passively through its range of motion, and the perceived resistance is evaluated. (MAS 0: No increase in muscle tone; 1. Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion; 1+: Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout less than half of the remainder of the range of motion; 2. More marked increase in muscle tone through most of the range of motion, but affected part(s) easily moved; 3. Considerable increase in muscle tone, passive movement difficult; 4. Affected part(s) rigid in flexion or extension).

次要结局

  • Timed Up and Go (TUG) Test(Patients included in the study will be evaluated at baseline (pre-treatment), immediately after the intervention (post-treatment), and at a 12-week follow-up from the start of treatment.)
  • Functional Mobility Scale (FMS)(Patients included in the study will be evaluated at baseline (pre-treatment), immediately after the intervention (post-treatment), and at a 12-week follow-up from the start of treatment.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Özlem Kaynar Şişman

assistant doctor

Ankara City Hospital Bilkent

研究点 (1)

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