rTMS plus neurorehabilitation to improve leg movement and reduce stiffness in children with spastic diplegic cerebral palsy
Impact of rTMS Combined With Neurorehabilitation on Lower Extremity Motor Function and Spasticity in Children With Spastic Diplegic Cerebral Palsy
This trial will test whether adding repetitive transcranial magnetic stimulation (rTMS) to structured neurorehabilitation helps children aged 5–18 with spastic diplegic cerebral palsy improve lower-extremity movement and reduce spasticity.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 5 Years to 18 Years |
| Sex | All |
| Sponsor | Ankara City Hospital Bilkent Academic / other |
| Locations | 1 site (Ankara) |
| Trial ID | NCT07488429 on ClinicalTrials.gov |
What this trial studies
Children with spastic diplegic cerebral palsy (GMFCS II–III) who meet safety criteria will receive repeated sessions of rTMS combined with a structured neurorehabilitation program. Motor function of the lower limbs and levels of spasticity will be measured before and after the intervention using standardized clinical scales. Participants with contraindications to rTMS (for example, epilepsy, cranial metal implants, recent botulinum toxin or surgery) are excluded for safety. The study is conducted at a single tertiary center with in-person treatment sessions and follow-up assessments.
Who should consider this trial
Good fit: Children aged 5–18 with a diagnosis of spastic diplegic cerebral palsy, classified as GMFCS level II or III, who can follow commands and have no contraindications to rTMS are ideal candidates.
Not a fit: Children with a history of seizures or epilepsy, cranial or cervical metal implants, recent botulinum toxin injections or surgery within six months, severe comorbid conditions, or poor ability to cooperate are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, this approach could improve walking ability and reduce muscle stiffness, helping children gain better mobility and daily function.
How similar studies have performed: Small prior studies of rTMS in pediatric cerebral palsy have shown some promising short-term improvements in motor control and spasticity, but evidence is limited and larger, controlled trials are still needed.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Where this trial is running
Ankara
- Ankara Bilkent City Hospital — Ankara, Turkey (Türkiye) (Recruiting)
Study contacts
- Principal investigator: canan çulha, professor doctor — Ankara City Hospital Bilkent
- Study coordinator: özlem kaynar şişman
- Email: cinekopus@gmail.com
- Phone: +90 5418479210
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.