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NCT06218316

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

Completed NA Last updated 19 September 2024
What this trial tests

NA trial testing botulinum toxin A in Spastic Diplegic Cerebral Palsy in 75 participants. Completed in 10 August 2024.

Timeline
15 October 2023
Primary endpoint
20 January 2024
10 August 2024

Quick facts

Lead sponsorMTI University
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment75
Start date15 October 2023
Primary completion20 January 2024
Estimated completion10 August 2024
Sites1 location across Egypt

Drugs / interventions tested

Conditions studied

Sponsor

MTI University

Who can join

Adults 4 to 4, any sex, with Spastic Diplegic Cerebral Palsy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Other trials of botulinum toxin A

Trials testing the same drug.

Other MTI University trials

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