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rTMS in Spastic Hemiplegic Cerebral Palsy Children

Primary Purpose

Cerebral Palsy

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Repetitive Transcranial Magnetic Stimulation
Sponsored by
Al-Azhar University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy focused on measuring cerebral palsy

Eligibility Criteria

4 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Al-Azhar universityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Study Group

Control Group

Arm Description

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.

The children in this group will receive traditional treatment of hemiplegic CP including medical treatment and physiotherapy for 4 weeks.

Outcomes

Primary Outcome Measures

Change in muscle spasticity
Assessment tools: Modified Ashworth Scale. It grades muscle spasticity between 0 to 4. Higher score mean a worse outcome.

Secondary Outcome Measures

Change in gross motor function
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.

Full Information

First Posted
November 20, 2021
Last Updated
February 14, 2022
Sponsor
Al-Azhar University
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1. Study Identification

Unique Protocol Identification Number
NCT05134259
Brief Title
rTMS in Spastic Hemiplegic Cerebral Palsy Children
Official Title
The Role of Repetitive Transcranial Magnetic Stimulation in Spastic Hemiplegic Cerebral Palsy in a Sample of Egyptian Children
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
July 1, 2022 (Anticipated)
Study Completion Date
August 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Al-Azhar University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
Keywords
cerebral palsy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Study Group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
The children in this group will receive traditional treatment of hemiplegic CP including medical treatment and physiotherapy for 4 weeks.
Intervention Type
Device
Intervention Name(s)
Repetitive Transcranial Magnetic Stimulation
Intervention Description
TMS device will deliver repetitive trains of magnetic pulses using Magstim Rapid 2 with angulated figure of eight shaped coil. The device comprised two-channel Neuro-EMG-MS digital system for determining the motor threshold of the patients that will be used for establishing the threshold intensity for stimulation. The figure of eight-shaped coil generated a magnetic field of up to 4 Tesla that penetrates the cranium, enters into the soft tissue of the brain and henceforth stimulates the motor neurons.
Primary Outcome Measure Information:
Title
Change in muscle spasticity
Description
Assessment tools: Modified Ashworth Scale. It grades muscle spasticity between 0 to 4. Higher score mean a worse outcome.
Time Frame
1 week following end of treatment
Secondary Outcome Measure Information:
Title
Change in gross motor function
Description
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.
Time Frame
1 week following end of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Willingness to participate. Age group between 4 and 18 years. They are able to walk with limitation or holding on according to Gross Motor Function classification System (GMFCS) (level II, III, IV). All patients have mild to moderate spasticity according to modified Ashworth scale (Grade 1, 1+,2). Exclusion Criteria: All Children with: Perceptual defects (IQ<70). Use of botulinum toxin in the past 4 months. Convulsions. Other peripheral or central nervous system dysfunction. Fixed deformities in lower limbs. Clinically suspected active inflammatory or pathologic changes in lower limb joints during the previous 6 months. Clinically suspected active medical problems, such as pneumonia, meningitis, encephalitis, upper gastrointestinal bleeding, or urinary tract infection. Metabolic disorders, such as inborn error of metabolism, electrolyte, and endocrine disorders. Metallic implants.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed A. Muhammad
Phone
0201093444878
Email
ahmed.a.muh@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Abdel-Ghaffar I. Fayed, Lecturer
Phone
0201018059585
Email
drfayed1984@azhar.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hossam M. Emam, professor
Organizational Affiliation
Faculty of Medicine, Al-Azhar University
Official's Role
Study Chair
Facility Information:
Facility Name
Al-Azhar university
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed A. Muhammad
Phone
0201093444878
Email
ahmed.a.muh@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30860516
Citation
Akpinar P. Vitamin D status of children with cerebral palsy: Should vitamin D levels be checked in children with cerebral palsy? North Clin Istanb. 2018 Aug 8;5(4):341-347. doi: 10.14744/nci.2017.09581.
Results Reference
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Citation
Allen CH, Kluger BM, Buard I. Safety of Transcranial Magnetic Stimulation in Children: A Systematic Review of the Literature. Pediatr Neurol. 2017 Mar;68:3-17. doi: 10.1016/j.pediatrneurol.2016.12.009. Epub 2017 Jan 4.
Results Reference
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PubMed Identifier
18435840
Citation
Anttila H, Autti-Ramo I, Suoranta J, Makela M, Malmivaara A. Effectiveness of physical therapy interventions for children with cerebral palsy: a systematic review. BMC Pediatr. 2008 Apr 24;8:14. doi: 10.1186/1471-2431-8-14.
Results Reference
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PubMed Identifier
20699783
Citation
Gray L, Ng H, Bartlett D. The gross motor function classification system: an update on impact and clinical utility. Pediatr Phys Ther. 2010 Fall;22(3):315-20. doi: 10.1097/PEP.0b013e3181ea8e52.
Results Reference
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PubMed Identifier
25206878
Citation
Gunduz A, Kumru H, Pascual-Leone A. Outcomes in spasticity after repetitive transcranial magnetic and transcranial direct current stimulations. Neural Regen Res. 2014 Apr 1;9(7):712-8. doi: 10.4103/1673-5374.131574.
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PubMed Identifier
30104744
Citation
Korzeniewski SJ, Slaughter J, Lenski M, Haak P, Paneth N. The complex aetiology of cerebral palsy. Nat Rev Neurol. 2018 Sep;14(9):528-543. doi: 10.1038/s41582-018-0043-6.
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PubMed Identifier
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Citation
Laakso I, Murakami T, Hirata A, Ugawa Y. Where and what TMS activates: Experiments and modeling. Brain Stimul. 2018 Jan-Feb;11(1):166-174. doi: 10.1016/j.brs.2017.09.011. Epub 2017 Sep 27.
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PubMed Identifier
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Citation
Michael-Asalu A, Taylor G, Campbell H, Lelea LL, Kirby RS. Cerebral Palsy: Diagnosis, Epidemiology, Genetics, and Clinical Update. Adv Pediatr. 2019 Aug;66:189-208. doi: 10.1016/j.yapd.2019.04.002. Epub 2019 May 15. No abstract available.
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PubMed Identifier
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Citation
Novak I, Morgan C, Adde L, Blackman J, Boyd RN, Brunstrom-Hernandez J, Cioni G, Damiano D, Darrah J, Eliasson AC, de Vries LS, Einspieler C, Fahey M, Fehlings D, Ferriero DM, Fetters L, Fiori S, Forssberg H, Gordon AM, Greaves S, Guzzetta A, Hadders-Algra M, Harbourne R, Kakooza-Mwesige A, Karlsson P, Krumlinde-Sundholm L, Latal B, Loughran-Fowlds A, Maitre N, McIntyre S, Noritz G, Pennington L, Romeo DM, Shepherd R, Spittle AJ, Thornton M, Valentine J, Walker K, White R, Badawi N. Early, Accurate Diagnosis and Early Intervention in Cerebral Palsy: Advances in Diagnosis and Treatment. JAMA Pediatr. 2017 Sep 1;171(9):897-907. doi: 10.1001/jamapediatrics.2017.1689. Erratum In: JAMA Pediatr. 2017 Sep 1;171(9):919.
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Citation
Rajak BL, Gupta M, Bhatia D, Mukherjee A. Increasing Number of Therapy Sessions of Repetitive Transcranial Magnetic Stimulation Improves Motor Development by Reducing Muscle Spasticity in Cerebral Palsy Children. Ann Indian Acad Neurol. 2019 Jul-Sep;22(3):302-307. doi: 10.4103/aian.AIAN_102_18.
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rTMS in Spastic Hemiplegic Cerebral Palsy Children

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