NCT05134259

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 20, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 24, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2022

Completed
Last Updated

February 15, 2022

Status Verified

November 1, 2021

Enrollment Period

6 months

First QC Date

November 20, 2021

Last Update Submit

February 14, 2022

Conditions

Cerebral Palsy

Keywords

cerebral palsy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Change in gross motor function

    1 week following end of treatment

Study Arms (2)

Study Group

ACTIVE COMPARATOR

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.

Device: Repetitive Transcranial Magnetic Stimulation

Control Group

NO INTERVENTION

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

Interventions

Repetitive Transcranial Magnetic StimulationDEVICE

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.

Study Group

Eligibility Criteria

Age4 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Al-Azhar university

Cairo, Egypt

RECRUITING

Related 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.

    PMID: 30860516BACKGROUND

  • 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.

    PMID: 28216033BACKGROUND

  • 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.

    PMID: 18435840BACKGROUND

  • 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.

    PMID: 20699783BACKGROUND

  • 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.

    PMID: 25206878BACKGROUND

  • 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.

    PMID: 30104744BACKGROUND

  • 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.

    PMID: 29030110BACKGROUND

  • 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.

    PMID: 31230694BACKGROUND

  • 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.

    PMID: 28715518BACKGROUND

  • 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.

    PMID: 18834387BACKGROUND

  • 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.

    PMID: 32206590BACKGROUND

  • 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.

    PMID: 31359942BACKGROUND

  • 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.

    PMID: 30175934BACKGROUND

  • 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.

    PMID: 19833552BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Study Officials

  • Hossam M. Emam, professor

    Faculty of Medicine, Al-Azhar University

    STUDY CHAIR

Central Study Contacts

Ahmed A. Muhammad

CONTACT

0201093444878ahmed.a.muh@gmail.com

Abdel-Ghaffar I. Fayed, Lecturer

CONTACT

0201018059585drfayed1984@azhar.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
physician

Study Record Dates

First Submitted

November 20, 2021

First Posted

November 24, 2021

Study Start

January 1, 2022

Primary Completion

July 1, 2022

Study Completion

August 1, 2022

Last Updated

February 15, 2022

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)