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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5-18
SponsorAnkara City Hospital Bilkent

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • TMS

    Device

    The objective of TMS is to stimulate neurons in targeted regions and their associated neuronal networks through an intact skull using a coil. This stimulation modulates the neuronal activity pattern in the targeted cortical area: it achieves this by providing an inhibitory effect when used at low frequencies (1-5 Hz) or an excitatory effect when used at high frequencies (5-20 Hz), thereby restoring neuronal balance in the brain. Magnetic stimulation will be performed using a Magstim Rapid2 Magnetic Stimulator (Magstim, Whitland, Dyfed, UK). The protocol includes 20 total sessions (5 times per week for 4 weeks), with each session lasting 20 minutes at a frequency of 5 Hz. Stimulation will be delivered using a 70 mm outer diameter figure-of-eight coil positioned at the midline of the cranial apex while the children are in a seated position providing a total of 1000 pulses per session.

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: rTMS + Comprehensive Neurological RehabilitationExperimental treatment 1 intervention
Group B: Comprehensive Neurological Rehabilitation AloneNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

GMFCS (Gross Motor Function Classification System)

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.

Time frame
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.
2

Modified Ashworth Scale (MAS)

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).

Time frame
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.
3

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

Gross Motor Function Measure-88 (GMFM-88), Sections D and E will be used to assess motor function. GMFM-88 is a standardized observational instrument used to evaluate gross motor abilities in children with cerebral palsy. Each item is scored on a 4-point scale (0-3), and section scores are converted into percentages ranging from 0 to 100. Higher scores indicate better motor function. Sections D and E assess standing and walking/running/jumping abilities, respectively.

Time frame
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.

Secondary outcomes

1

Timed Up and Go (TUG) Test

he Timed Up and Go (TUG) test is a practical and reliable tool used to assess functional mobility, dynamic balance, and transfer skills in children. It is a sensitive measure for monitoring changes in gross motor function, particularly in children with CP.

Time frame
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.
2

Functional Mobility Scale (FMS)

The FMS is an assessment system designed to measure changes in walking ability that can be observed following interventions. The FMS classifies children's performance across three distances (5, 50, and 500 meters) based on their need for a wheelchair or assistive devices. Unlike the GMFCS, significant changes in FMS levels are observed following orthopedic surgery or other clinical interventions.

Time frame
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.

Other outcomes

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