NCT06218316

Repetitive Transcranial Magnetic Stimulation Versus Botulinum Injection on Spasticity on Children With Diplegic Cerebral Palsy

Combined Effect of Repetitive Transcranial Magnetic Stimulation and Botulinum Injection on Spasticity and Motor Functions of Children With Diplegic Cerebral Palsy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: MTI University · Academic / Other
• Sex: All
• Age: 4 Years – 4 Years
• Healthy volunteers: Accepted

Summary

This trial will enroll 75 children with spastic diplegic cerebral palsy both matched in age, sex, degree of disability and cognitive functions with the same exclusion criteria undergoing the same physical therapy. All enrolled children will undergo routine physical therapy program and will be divided into three groups (n = 25 per group) according treatment methods. Group A: children will be given local injections of botulinum toxin type ,Group B: children will be given repetitive transcranial magnetic stimulation on the affected side; Group C: children will be given local injections of botulinum toxin type A combined with repetitive transcranial magnetic stimulation , the three groups will take physical therapy (PT) of 45 minutes duration 4 days a week for 3 months .The grade of spasticity will be assessed by using Modified Ashworth scale and M/H ratio by using EMG. The grade of motor function will assessed by using Gross Motor Function Classification System (GMFCS).

Detailed description

This trial will enrol 75 children with spastic diaplegic cerebral palsy with both sex, degree of disability and cognitive functions with the same exclusion criteria and the same physical therapy program. All enrolled children will undergo routine physical therapy program and will be divided into three groups (n = 25 per group) according treatment methods. Group A: children will be given local injections of botulinum toxin type ,Group B: children will be given repetitive transcranial magnetic stimulation on the affected side; Group C: children will be given local injections of botulinum toxin type A combined with repetitive transcranial magnetic stimulation , the three groups will take physical therapy (PT) of 45 minutes duration 4 days a week for 3 months. They will diagnosed based on history taking including perinatal, developmental, and family history, general and neurological examination. The included children with clinical diagnosis of moderate spastic diplegic cerebral palsy with a MAS (1, 1+, 2) and GMFCS (II, III, IV) will participated in this study. On the contrary, children with dyskinetic CP, mental retardation, previous ankle or knee surgery, uncontrolled epileptic seizure or contracture will excluded

Conditions

• Spastic Diplegic Cerebral Palsy

Interventions

Type	Name	Description
DRUG	botulinum toxin A	Botulinum Neurotoxin A (BoNT-A) Injections will administered directly into the bulk of the muscles, with two injection sites at each head of the gastrocnemius and two sites into the medial hamstring. one vial of BoNT-A in 2 mL of 0.9% sodium chloride solution. followed by a 3-month rehabilitation program. The entire intervention including rTMS, BoNT-A, and rehabilitation training program spanned a period of three months.
DEVICE	Transcranial Magnetic Stimulation	Repeated Transcranial Magnetic Stimulation (rTMS) Stimulation coil will strategically place on the primary motor cortex (M1), The patients received 1500 pulses per session, two sessions per week for 3 months, in a combination with 3-month rehabilitation program.
OTHER	Rehabilitation Training Protocol	Rehabilitation Training Protocol: As part of the study protocol, all participating children underwent a comprehensive weekly routine rehabilitation training program. Training Schedule: sessions will conduct for duration of 45 minutes. Training occurred four days a week.

Timeline

• Start date: 2023-10-15
• Primary completion: 2024-01-20
• Completion: 2024-08-10
• First posted: 2024-01-23
• Last updated: 2024-09-19

Locations

1 site across 1 country: Egypt