- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
Study Overview
Status
Conditions
Intervention / Treatment
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
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Cairo, Egypt
- faculty of pysical therapy, MTI university
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Botox for spasticity
Botox for spasticity in lower limbs in cerebral palsy children
|
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: 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.
|
Experimental: transcranial magnetic stimulation for spasticity
transcranial magnetic stimulation for spasticity in cerebral palsy children
|
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.
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.
|
Experimental: Botox combined with transcranial magnetic stimulation for spasticity
Botox combined with transcranial magnetic stimulation for spasticity in cerebral palsy children
|
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: 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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
modified aswthor scale
Time Frame: 3 months
|
Modified Ashworth Scale (MAS): The MAS measures the resistance and spasticity in the joint during passive movement.
The resistance is scored from 0 to 5 (0 the least severe to 5 the most severe
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Gross Motor Function Classification System
Time Frame: 3 months
|
Gross Motor Function Classification System (GMFCS): The GMFCS provides a standardized system to classify the gross motor function of children with CP into five levels (level I the least severe to level V the most severe)
|
3 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Electromyography
Time Frame: 3 months
|
The Hofmann's reflex or H-reflex, as measured by electromyography (EMG), has been used to assess spasticity.
The H-reflex measures the threshold spinal reflex reaction in muscles after electrical stimulation of the peripheral nerve, believed to be indicative of alpha motor neuron excitability.
People with spasticity have increased alpha motor neuron excitability and increased H-reflex amplitude and following M-response, thus allowing measurement of the H-reflex, the M-response, and the H/M ratio
|
3 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Brain Damage, Chronic
- Cerebral Palsy
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Cholinergic Agents
- Membrane Transport Modulators
- Acetylcholine Release Inhibitors
- Neuromuscular Agents
- Botulinum Toxins
- Botulinum Toxins, Type A
- abobotulinumtoxinA
Other Study ID Numbers
- cairo university (Other Grant/Funding Number: faculty of pedatric dentistry)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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