Cerebral PalsyNCT05134259
rTMS in Spastic Hemiplegic Cerebral Palsy Children
A study testing Repetitive Transcranial Magnetic Stimulation in people with Cerebral Palsy, run by Al-Azhar University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 4 to 18 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Repetitive Transcranial Magnetic Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2022to 1 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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).
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Al-Azhar university
Cairo
Ahmed A. Muhammad, 0201093444878, ahmed.a.muh@gmail.com
About this study
Official title: The Role of Repetitive Transcranial Magnetic Stimulation in Spastic Hemiplegic Cerebral Palsy in a Sample of Egyptian Children
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.
Read the 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.
- Conditions
- Cerebral Palsy
- Being tested
- Repetitive Transcranial Magnetic Stimulation
- Keywords
- cerebral palsy
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in muscle spasticity
Assessment tools: Modified Ashworth Scale. It grades muscle spasticity between 0 to 4. Higher score mean a worse outcome.
Measured: 1 week following end of treatment
Secondary outcomes (1)
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.
Measured: 1 week following end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2021
- Study start1 Jan 2022
- Primary completion1 Jul 2022 (estimated)
- Study completion1 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Al-Azhar UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Abdel Fattah Muhammad, Al-Azhar University
- Investigators
- Hossam M. Emam, professor, Study chair, Faculty of Medicine, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05134259
- Sponsor's protocol ID
- 0000043
- Status last verified
- Nov 2021
- First submitted
- 20 Nov 2021
- Last updated
- 15 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30860516Allen 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.
PubMed 28216033Anttila 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.
PubMed 18435840Gray 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.
PubMed 20699783Gunduz 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.
PubMed 25206878Korzeniewski 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.
PubMed 30104744Laakso 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.
PubMed 29030110Michael-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.
PubMed 31230694Novak 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.
PubMed 28715518Palisano 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.
PubMed 18834387Patel 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.
PubMed 32206590Rajak 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.
PubMed 31359942Gupta 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.
PubMed 30175934Rossi 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.
PubMed 19833552
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Repetitive Transcranial Magnetic Stimulation in Spastic Hemiplegic Cerebral Palsy in a Sample of Egyptian Children
- ClinicalTrials.gov ID
- NCT05134259
- Acronym / sponsor ID
- 0000043
- Conditions
- Cerebral Palsy
- Keywords
- cerebral palsy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Jul 2022 (estimated)
- Study completion
- 1 Aug 2022 (estimated)
- First posted
- 24 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group | Active comparator | Device: Repetitive Transcranial Magnetic StimulationThe 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. |
| Control Group | No intervention | –The children in this group will receive traditional treatment of hemiplegic CP including medical treatment and physiotherapy for 4 weeks. |
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (10 listed)
- All Children with:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Repetitive Transcranial Magnetic StimulationTMS 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. | Device | Study Group |
Primary outcome
Change in muscle spasticity
Time frame: 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.
1 secondary outcome
Change in gross motor function
Time frame: 1 week following end of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2022.
- Background: PubMed 30860516Akpinar 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.
- Background: PubMed 28216033Allen 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.
- Background: PubMed 18435840Anttila 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.
- Background: PubMed 20699783Gray 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.
- Background: PubMed 25206878Gunduz 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.
- Background: PubMed 30104744Korzeniewski 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.
- Background: PubMed 29030110Laakso 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.
- Background: PubMed 31230694Michael-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.
- Background: PubMed 28715518Novak 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.
- Background: PubMed 18834387Palisano 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.
- Background: PubMed 32206590Patel 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.
- Background: PubMed 31359942Rajak 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hossam M. Emam, professor study chair
Faculty of Medicine, Al-Azhar University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Repetitive Transcranial Magnetic Stimulation in people with Cerebral Palsy, run by Al-Azhar University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed A. Muhammad (0201093444878, ahmed.a.muh@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in muscle spasticity (time frame: 1 week following end of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05134259, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2022.