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

NCT ID: NCT06218316

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-15
• Study Completion Date: 2024-08-10

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Botox for spasticity

Botox for spasticity in lower limbs in cerebral palsy children

Group Type: EXPERIMENTAL

botulinum toxin A

Intervention Type: DRUG

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.

Rehabilitation Training Protocol

Intervention Type: OTHER

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.

transcranial magnetic stimulation for spasticity

transcranial magnetic stimulation for spasticity in cerebral palsy children

Group Type: EXPERIMENTAL

Transcranial Magnetic Stimulation

Intervention Type: DEVICE

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.

Rehabilitation Training Protocol

Intervention Type: OTHER

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.

Botox combined with transcranial magnetic stimulation for spasticity

Botox combined with transcranial magnetic stimulation for spasticity in cerebral palsy children

Group Type: EXPERIMENTAL

botulinum toxin A

Intervention Type: DRUG

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.

Transcranial Magnetic Stimulation

Intervention Type: DEVICE

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.

Rehabilitation Training Protocol

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: DEVICE

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• were diagnosed based on history taking including perinatal, developmental, and family history, general and neurological examination.

The included children with clinical diagnosis of moderate spastic dialogic cerebral palsy with a MAS (1, 1+, 2) and GMFCS (II, III, IV) were participated in this study

Exclusion Criteria

Children who's contraindicated to rTMS treatment have metal implants such as internal pacemakers and intracranial scaffolds, and/or a history of epilepsy.

• Children who's Contraindicated for BTX-A treatment: hypersensitivity and local infection at the injection site.
• Children which have received a local injection of BTX-A within 3 months.
• Children with dyskinetic CP,
• Mental retardation,
• previous, seizure or contracture were excluded.

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 4 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

MTI University

OTHER

Sponsor Role: lead

Responsible Party

Rana Nabil Hussein Mohamed

lecturer of pediatric physical therapy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

faculty of pysical therapy, MTI university

Cairo, , Egypt

Countries

Egypt

Other Identifiers

P.T.REC/012/004846

Identifier Type: -

Identifier Source: org_study_id