rTMS in Spastic Hemiplegic Cerebral Palsy Children

Not Applicable

• Conditions: Cerebral Palsy
• Interventions: Device: Repetitive Transcranial Magnetic Stimulation

• Registration Number: NCT05134259
• Lead Sponsor: Al-Azhar University

Brief Summary

The aim of the work is to study the role of repetitive transcranial magnetic stimulation (rTMS) in spastic hemiplegic cerebral palsy in a Sample of Egyptian Children.

Detailed Description

Prior to start of rTMS therapy, Gross Motor Function Classification System (GMFCS) will be employed on the participants to classify gross motor function. Also, Modified Ashworth Scale (MAS) scoring will be employed on the participants to access spasticity on selected muscles namely, hamstring, soleus, gastrocnemius and adductor of lower limb; and bicep, supinator and wrist extensor of upper limb.

rTMS frequency of 10 Hz will be delivered to each of the participants in the study group for 15 minutes per session. Each session will be administered once daily for 2 days a week for 4 weeks. 1500 pulses (50 pulses per train with total 30 trains having inter- train delay of 25 seconds) per session will be provided with the coil placed on the contralateral primary motor cortex (M1) which is known to produce modulatory effect on muscle tightness of the limbs (Rajak et al. 2017). rTMS frequency of 10 Hz was kept constant based on previous studies with 5 Hz and 10 Hz (Anttila et al. 2008) (Rossi 2009).

Each session will be followed by physical therapy (PT) according to physiotherapy protocol. After completion of therapeutic programs (after 4 weeks), the participants will be asked to undergo post assessment of Gross Motor Function Classification System (GMFCS), and Modified Ashworth Scale (MAS) scoring on exactly the same muscles as recorded previously. Both PT and rTMS sessions will be administered by trained professionals who was kept blinded to the research protocols used in the study.

Study Timeline

• Status Verified: 2021-11
• Study First Submitted: 2021-11-20
• Study First Submitted QC: 2021-11-23
• Study First Posted: 2021-11-24
• Study Start: 2022-01-01
• Last Update Submitted: 2022-02-14
• Last Update Posted: 2022-02-15
• Primary Completion: 2022-07-01
• Study Completion: 2022-08-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Willingness to participate.
2. Age group between 4 and 18 years.
3. They are able to walk with limitation or holding on according to Gross Motor Function classification System (GMFCS) (level II, III, IV).
4. All patients have mild to moderate spasticity according to modified Ashworth scale (Grade 1, 1+,2).

Exclusion Criteria

• All Children with:

  1. Perceptual defects (IQ<70).
  2. Use of botulinum toxin in the past 4 months.
  3. Convulsions.
  4. Other peripheral or central nervous system dysfunction.
  5. Fixed deformities in lower limbs.
  6. Clinically suspected active inflammatory or pathologic changes in lower limb joints during the previous 6 months.
  7. Clinically suspected active medical problems, such as pneumonia, meningitis, encephalitis, upper gastrointestinal bleeding, or urinary tract infection.
  8. Metabolic disorders, such as inborn error of metabolism, electrolyte, and endocrine disorders.
  9. Metallic implants.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study Group	Repetitive Transcranial Magnetic Stimulation	The children in this group will receive traditional treatment of hemiplegic CP including medical treatment and physiotherapy in addition to repetitive transcranial magnetic stimulation sessions for 4 weeks.

Primary Outcome Measures

Name	Time	Method
Change in muscle spasticity	1 week following end of treatment	Assessment tools: Modified Ashworth Scale. It grades muscle spasticity between 0 to 4. Higher score mean a worse outcome.

Secondary Outcome Measures

Name	Time	Method
Change in gross motor function	1 week following end of treatment	Gross Motor Function Classification System (GMFCS). It includes five levels and four age bands. Classifications are made based on the child's self-initiated movements with emphasis on sitting and walking. Higher score mean a worse outcome.

Trial Locations

Locations (1)

Al-Azhar university; 🇪🇬 Cairo, Egypt