rTMS in Spastic Hemiplegic Cerebral Palsy Children

Cerebral Palsy Clinical Trial

Official title:

The Role of Repetitive Transcranial Magnetic Stimulation in Spastic Hemiplegic Cerebral Palsy in a Sample of Egyptian Children

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05134259
• Other study ID #: 0000043
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: August 1, 2022

Study information

• Verified date: November 2021
• Source: Al-Azhar University
• Contact: Ahmed A. Muhammad
• Phone: 0201093444878
• Email: ahmed.a.muh[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: August 1, 2022
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cerebral Palsy
• Paralysis

Intervention

Device:
• Repetitive Transcranial Magnetic Stimulation
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.

Locations

Country	Name	City	State
Egypt	Al-Azhar university	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Al-Azhar University

Country where clinical trial is conducted

Egypt, 

References & Publications (14)

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. — View 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. Review. — View Citation

Anttila H, Autti-Rämö I, Suoranta J, Mäkelä 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. Review. — View 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. Review. — View 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. Review. — View Citation

Gupta M, Rajak BL, Bhatia D, Mukherjee A. Neuromodulatory effect of repetitive transcranial magnetic stimulation pulses on functional motor performances of spastic cerebral palsy children. J Med Eng Technol. 2018 Jul;42(5):352-358. doi: 10.1080/03091902.2018.1510555. Epub 2018 Sep 3. — View 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. Review. — View 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. — View 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. Review. — View 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. Review. Erratum in: JAMA Pediatr. 2017 Sep 1;171(9):919. — View Citation

Palisano RJ, Rosenbaum P, Bartlett D, Livingston MH. Content validity of the expanded and revised Gross Motor Function Classification System. Dev Med Child Neurol. 2008 Oct;50(10):744-50. doi: 10.1111/j.1469-8749.2008.03089.x. — View Citation

Patel DR, Neelakantan M, Pandher K, Merrick J. Cerebral palsy in children: a clinical overview. Transl Pediatr. 2020 Feb;9(Suppl 1):S125-S135. doi: 10.21037/tp.2020.01.01. Review. — View 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. — View Citation

Rossi S, Hallett M, Rossini PM, Pascual-Leone A; Safety of TMS Consensus Group. Safety, ethical considerations, and application guidelines for the use of transcranial magnetic stimulation in clinical practice and research. Clin Neurophysiol. 2009 Dec;120(12):2008-2039. doi: 10.1016/j.clinph.2009.08.016. Epub 2009 Oct 14. Review. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in muscle spasticity	Assessment tools: Modified Ashworth Scale. It grades muscle spasticity between 0 to 4. Higher score mean a worse outcome.	1 week following end of treatment
Secondary	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.	1 week following end of treatment