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

NCT07488429 | Recruiting

• 1 other identifier: E2-25-10341
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Diplegic Cerebral Palsy With Spasticity; Cerebral Palsy, Spastic, Diplegic; Transcranial Magnetic Stimilation; Cerebral Palsy (CP)

Outcome Measures

Primary Outcomes (2)

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

  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.

  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.

• 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).

  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 (2)

• 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.

Study Arms (2)

rTMS + Comprehensive Neurological Rehabilitation

EXPERIMENTAL

Participants receive 20 sessions of 5 Hz rTMS (1,500 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)

Device: TMS

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

Interventions

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 1,500 pulses per session.

rTMS + Comprehensive Neurological Rehabilitation

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara Bilkent City Hospital

Ankara, Turkey (Türkiye)

RECRUITING

Related Publications (4)

• Li J, Chen C, Zhu S, Niu X, Yu X, Ren J, Shen M. Evaluating the Effects of 5-Hz Repetitive Transcranial Magnetic Stimulation With and Without Wrist-Ankle Acupuncture on Improving Spasticity and Motor Function in Children With Cerebral Palsy: A Randomized Controlled Trial. Front Neurosci. 2021 Dec 15;15:771064. doi: 10.3389/fnins.2021.771064. eCollection 2021.

  PMID: 34975377 BACKGROUND

• Frye RE, Rotenberg A, Ousley M, Pascual-Leone A. Transcranial magnetic stimulation in child neurology: current and future directions. J Child Neurol. 2008 Jan;23(1):79-96. doi: 10.1177/0883073807307972. Epub 2007 Dec 3.

  PMID: 18056688 BACKGROUND

• He Y, Zhang Q, Ma TT, Liang YH, Guo RR, Li XS, Liu QJ, Feng TY. Effect of repetitive transcranial magnetic stimulation-assisted training on lower limb motor function in children with hemiplegic cerebral palsy. BMC Pediatr. 2024 Feb 22;24(1):136. doi: 10.1186/s12887-024-04605-5.

  PMID: 38383331 BACKGROUND

• Rosenbaum P, Paneth N, Leviton A, Goldstein M, Bax M, Damiano D, Dan B, Jacobsson B. A report: the definition and classification of cerebral palsy April 2006. Dev Med Child Neurol Suppl. 2007 Feb;109:8-14.

  PMID: 17370477 BACKGROUND

MeSH Terms

Conditions

Cerebral palsy, spastic, diplegic; Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• canan çulha, professor doctor

  Ankara City Hospital Bilkent

  PRINCIPAL INVESTIGATOR

Central Study Contacts

özlem kaynar şişman

CONTACT

+90 5418479210; cinekopus@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant doctor

Study Record Dates

• First Submitted: March 18, 2026
• First Posted: March 23, 2026
• Study Start: May 5, 2025
• Primary Completion (Estimated): September 5, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)