Clinical trial NCT05134259: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Cerebral Palsy
Keywords: cerebral palsy
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2021-11-24
Enrollment: 60
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in muscle spasticity
timeFrame: 1 week following end of treatment
Secondary outcomes:
measure: Change in gross motor function
timeFrame: 1 week following end of treatment
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Al-Azhar university
Study officials:
affiliation: Faculty of Medicine, Al-Azhar University
name: Hossam M. Emam, professor
role: STUDY_CHAIR
References:
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.