Patients with Multiple SclerosisNCT06265922
Cerebellar RTMS in Patients with Multiple Sclerosis
A study testing High frequency repetitive transcranial magnetic stimulation in people with Patients with Multiple Sclerosis, run by Cairo University at 1 site in Egypt.
Trial summary
To determine the efficacy of high frequency cerebellar repetitive transcranial magnetic stimulation on coordination in patients with multiple sclerosis. Read more about this study
- Who is it for?
- Ages 20 to 45 years
- Conditions the study is for
- Patients with Multiple Sclerosis
- What is being tested?
- High frequency repetitive transcranial magnetic stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 18 Feb 2024to 5 Aug 2024
- 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 20 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Clinically definite MS (relapsing, remitting and secondary progressive) patients
- Patients who are medically stable and Free from relapses three months before
- Ambulant patients without an assistive device and score less than 5 on the Kurtzke Expanded Disability Status Scale (EDSS)
- Patients receiving their disease modifying drugs but no medication changing during the previous three months.
- Patients who had MRI evidence of lesions in the cerebellum or in the cerebellar pedunculi.
- Right handed patients.
- Severity of ataxia range from 4 to 10 according to scale of assessment and rating ataxia (SARA).
- Did not apply cerebellar transcranial magnetic stimulation before.
Who cannot join
- Any other neurological deficits or orthopedics abnormalities.
- Ataxic manifestations for other cause rather than Multiple Sclerosis.
- Other neurological manifestations (e.g. spasticity, visual loss)
- Secondary musculoskeletal complication such as contractures or deformities. Cardiovascular, pulmonary, hepatic, renal, hemopoietic and thyroid diseases.
- Pregnant women.
- Addicted individuals.
Show all 9Show fewer
- Previous surgeries in the brain.
- Any magnetic or metallic devices implanted (like cochlear implants) .
- Psychotic deficits or history of epileptic seizures.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Cerebellar Repetitive Transcranial Magnetic Stimulation on Coordination in Patients with Multiple Sclerosis
To determine the efficacy of high frequency cerebellar repetitive transcranial magnetic stimulation on coordination in patients with multiple sclerosis.
Read the detailed description
Forty patients with multiple sclerosis suffering from ataxia less than five in EDSS score will be recruited from the outpatient clinic at Faculty of Physical Therapy as well as Kasr Al-Ainy Multiple Sclerosis unit (KAMSU), Cairo University. The study will be applied during the remission period. Patients will be assessed by Biodex balance system, Berg balance scale, Four square step test and Nine-Hole Peg Test to investigate coordination in both equilibrium and non-equilibrium. Patient will be divided into two groups.The study group will be treated by High frequecy cerebellar repetitive transcranial magnetic stimulation besides a tailored physiotherapy program, while the control group will be treated by Sham cerebellar repetitive transcranial magnetic stimulation with a tailored physiotherapy program as well. The treatment duration for each patient will take weeks.
- Conditions
- Patients with Multiple Sclerosis
- Being tested
- High frequency repetitive transcranial magnetic stimulation, Sham repetitive transcranial magnetic stimulation
- Keywords
- Patients with Multiple Sclerosis, Coordination, Transcranial magnetic stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High frequency repetitive transcranial magnetic stimulationDevice
Also called Hf-rTMS
High frequency repetitive transcranial magnetic stimulation will be applied over mid line of cerebellum using circular coil. Ten repetition rate (frequency) in 40 trains with one intertrain interval will be applied for three times a week for two weeks.
Sham repetitive transcranial magnetic stimulationDevice
Sham repetitive transcranial magnetic stimulation will be applied Perpendicular away from the cerebellum using the same circular coil. The same parameters will be used with the same duration also numbers of sessions are the same like the active comparator group to assure the patients blindness
| Study group | Role | What they receive |
|---|---|---|
| High frequency cerebellar repetitive transcranial magnetic stimulation | Active comparator | Twenty patients will be treated by high frequency repetitive transcranial magnetic stimulation (Hf-rTMS) targeting the cerebellum beside a tailored physical therapy program designed for the ataxic manifestation The protocol of rTMS included 6 sessions over 2 weeks. MagPro R20 device will be applied over midline of cerebellum using circular coil. Ten repetition rate in 40 trains with one inter train interval will be applied two times within the same session, 5 minutes rest in between Tailored physiotherapy program for ataxic manifestation will be applied for 10 days in the same 2 weeks Receives: Device: High frequency repetitive transcranial magnetic stimulation |
| Sham cerebellar repetitive transcranial magnetic stimulation | Sham comparator | Twenty patients will be treated by sham cerebellar rTMS with the same parameters, same duration 6 sessions over 2 weeks except the coil will not be on the middle of the cerebellum instead it will be perpendicular away from it.
But the program of physiotherapy is the same Receives: Device: Sham repetitive transcranial magnetic stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biodex balance system
Change of balance and stability index from baseline to 2 weeks after the beginning of intervention (when the score decreases, this means good)
Measured: 2 weeks after end of treatment
Secondary outcomes (3)
Berg balance scale
Change of the balance score from baseline to two weeks after the beginning of the intervention ( the scale consists of 14 item. Minimum score for each item is 0 and maximum score is 4, to record the patient the summation of the 14 item is counted. And if the score is increasing this means good)
Measured: 2 weeks after end of treatment
Nine-Hole Peg Test (9-HPT)
Change of manual dexterity of both the dominant and non dominant hand from baseline to 2 weeks after the beginning of intervention
Measured: 2 weeks after end of treatment
Four square step test (FSST)
Change of dynamic balance and coordination from baseline to 2 weeks after the beginning of intervention
Measured: 2 weeks after 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 posted20 Feb 2024
- Study start18 Feb 2024
- Primary completion17 Jul 2024
- Study completion5 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Patients with Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Cairo 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, Care provider
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hoda Zayed Abd Elraheem Mohamed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06265922
- Sponsor's protocol ID
- P.T.REC/012/003937
- Status last verified
- Feb 2024
- First submitted
- 11 Feb 2024
- Last updated
- 19 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lefaucheur JP, Aleman A, Baeken C, Benninger DH, Brunelin J, Di Lazzaro V, Filipovic SR, Grefkes C, Hasan A, Hummel FC, Jaaskelainen SK, Langguth B, Leocani L, Londero A, Nardone R, Nguyen JP, Nyffeler T, Oliveira-Maia AJ, Oliviero A, Padberg F, Palm U, Paulus W, Poulet E, Quartarone A, Rachid F, Rektorova I, Rossi S, Sahlsten H, Schecklmann M, Szekely D, Ziemann U. Evidence-based guidelines on the therapeutic use of repetitive transcranial magnetic stimulation (rTMS): An update (2014-2018). Clin Neurophysiol. 2020 Feb;131(2):474-528. doi: 10.1016/j.clinph.2019.11.002. Epub 2020 Jan 1.
PubMed 31901449Aloizou AM, Pateraki G, Anargyros K, Siokas V, Bakirtzis C, Liampas I, Nousia A, Nasios G, Sgantzos M, Peristeri E, Dardiotis E. Transcranial magnetic stimulation (TMS) and repetitive TMS in multiple sclerosis. Rev Neurosci. 2021 Feb 25;32(7):723-736. doi: 10.1515/revneuro-2020-0140. Print 2021 Nov 25.
PubMed 33641274Somaa FA, de Graaf TA, Sack AT. Transcranial Magnetic Stimulation in the Treatment of Neurological Diseases. Front Neurol. 2022 May 20;13:793253. doi: 10.3389/fneur.2022.793253. eCollection 2022.
PubMed 35669870Mohamed HZA, Elwishy AA, Shalaby NM, Shehata HSM, Ali AS. Cerebellar repetitive transcranial magnetic stimulation combined with physiotherapy for balance in people with multiple sclerosis: A randomized controlled trial with six-week follow-up. Mult Scler Relat Disord. 2025 Oct;102:106610. doi: 10.1016/j.msard.2025.106610. Epub 2025 Jul 9.
PubMed 40664092
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Cerebellar Repetitive Transcranial Magnetic Stimulation on Coordination in Patients with Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT06265922
- Acronym / sponsor ID
- P.T.REC/012/003937
- Conditions
- Patients with Multiple Sclerosis
- Keywords
- Patients with Multiple Sclerosis, Coordination, Transcranial magnetic stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 18 Feb 2024 (actual)
- Primary completion
- 17 Jul 2024 (actual)
- Study completion
- 5 Aug 2024 (actual)
- First posted
- 20 Feb 2024 (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.
To determine the efficacy of high frequency cerebellar repetitive transcranial magnetic stimulation on coordination in patients with multiple sclerosis.
Detailed description
Forty patients with multiple sclerosis suffering from ataxia less than five in EDSS score will be recruited from the outpatient clinic at Faculty of Physical Therapy as well as Kasr Al-Ainy Multiple Sclerosis unit (KAMSU), Cairo University. The study will be applied during the remission period. Patients will be assessed by Biodex balance system, Berg balance scale, Four square step test and Nine-Hole Peg Test to investigate coordination in both equilibrium and non-equilibrium. Patient will be divided into two groups.The study group will be treated by High frequecy cerebellar repetitive transcranial magnetic stimulation besides a tailored physiotherapy program, while the control group will be treated by Sham cerebellar repetitive transcranial magnetic stimulation with a tailored physiotherapy program as well. The treatment duration for each patient will take weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High frequency cerebellar repetitive transcranial magnetic stimulation | Active comparator | Device: High frequency repetitive transcranial magnetic stimulationTwenty patients will be treated by high frequency repetitive transcranial magnetic stimulation (Hf-rTMS) targeting the cerebellum beside a tailored physical therapy program designed for the ataxic manifestation The protocol of rTMS included 6 sessions over 2 weeks. MagPro R20 device will be applied over midline of cerebellum using circular coil. Ten repetition rate in 40 trains with one inter train interval will be applied two times within the same session, 5 minutes rest in between Tailored physiotherapy program for ataxic manifestation will be applied for 10 days in the same 2 weeks |
| Sham cerebellar repetitive transcranial magnetic stimulation | Sham comparator | Device: Sham repetitive transcranial magnetic stimulationTwenty patients will be treated by sham cerebellar rTMS with the same parameters, same duration 6 sessions over 2 weeks except the coil will not be on the middle of the cerebellum instead it will be perpendicular away from it. But the program of physiotherapy is the same |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Clinically definite MS (relapsing, remitting and secondary progressive) patients
- Patients who are medically stable and Free from relapses three months before
- Ambulant patients without an assistive device and score less than 5 on the Kurtzke Expanded Disability Status Scale (EDSS)
- Patients receiving their disease modifying drugs but no medication changing during the previous three months.
- Patients who had MRI evidence of lesions in the cerebellum or in the cerebellar pedunculi.
Key exclusion criteria (9 listed)
- Any other neurological deficits or orthopedics abnormalities.
- Ataxic manifestations for other cause rather than Multiple Sclerosis.
- Other neurological manifestations (e.g. spasticity, visual loss)
- Secondary musculoskeletal complication such as contractures or deformities. Cardiovascular, pulmonary, hepatic, renal, hemopoietic and thyroid diseases.
- Pregnant women.
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 |
|---|---|---|
| High frequency repetitive transcranial magnetic stimulationAlso: Hf-rTMSHigh frequency repetitive transcranial magnetic stimulation will be applied over mid line of cerebellum using circular coil. Ten repetition rate (frequency) in 40 trains with one intertrain interval will be applied for three times a week for two weeks. | Device | High frequency cerebellar repetitive transcranial magnetic stimulation |
| Sham repetitive transcranial magnetic stimulationSham repetitive transcranial magnetic stimulation will be applied Perpendicular away from the cerebellum using the same circular coil. The same parameters will be used with the same duration also numbers of sessions are the same like the active comparator group to assure the patients blindness | Device | Sham cerebellar repetitive transcranial magnetic stimulation |
Primary outcome
Biodex balance system
Time frame: 2 weeks after end of treatment
Change of balance and stability index from baseline to 2 weeks after the beginning of intervention (when the score decreases, this means good)
3 secondary outcomes
Berg balance scale
Time frame: 2 weeks after end of treatment
Nine-Hole Peg Test (9-HPT)
Time frame: 2 weeks after end of treatment
Four square step test (FSST)
Time frame: 2 weeks after end of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2025.
- Background: PubMed 31901449Lefaucheur JP, Aleman A, Baeken C, Benninger DH, Brunelin J, Di Lazzaro V, Filipovic SR, Grefkes C, Hasan A, Hummel FC, Jaaskelainen SK, Langguth B, Leocani L, Londero A, Nardone R, Nguyen JP, Nyffeler T, Oliveira-Maia AJ, Oliviero A, Padberg F, Palm U, Paulus W, Poulet E, Quartarone A, Rachid F, Rektorova I, Rossi S, Sahlsten H, Schecklmann M, Szekely D, Ziemann U. Evidence-based guidelines on the therapeutic use of repetitive transcranial magnetic stimulation (rTMS): An update (2014-2018). Clin Neurophysiol. 2020 Feb;131(2):474-528. doi: 10.1016/j.clinph.2019.11.002. Epub 2020 Jan 1.
- Background: PubMed 33641274Aloizou AM, Pateraki G, Anargyros K, Siokas V, Bakirtzis C, Liampas I, Nousia A, Nasios G, Sgantzos M, Peristeri E, Dardiotis E. Transcranial magnetic stimulation (TMS) and repetitive TMS in multiple sclerosis. Rev Neurosci. 2021 Feb 25;32(7):723-736. doi: 10.1515/revneuro-2020-0140. Print 2021 Nov 25.
- Background: PubMed 35669870Somaa FA, de Graaf TA, Sack AT. Transcranial Magnetic Stimulation in the Treatment of Neurological Diseases. Front Neurol. 2022 May 20;13:793253. doi: 10.3389/fneur.2022.793253. eCollection 2022.
- Derived from this study: PubMed 40664092Mohamed HZA, Elwishy AA, Shalaby NM, Shehata HSM, Ali AS. Cerebellar repetitive transcranial magnetic stimulation combined with physiotherapy for balance in people with multiple sclerosis: A randomized controlled trial with six-week follow-up. Mult Scler Relat Disord. 2025 Oct;102:106610. doi: 10.1016/j.msard.2025.106610. Epub 2025 Jul 9.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High frequency repetitive transcranial magnetic stimulation in people with Patients with Multiple Sclerosis, run by Cairo 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 8 inclusion and 9 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: finished, as of the sponsor's last update on 19 Feb 2025. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biodex balance system (time frame: 2 weeks after 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 NCT06265922, which also lists 4 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 19 Feb 2025.