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To determine the efficacy of high frequency cerebellar repetitive transcranial magnetic stimulation on coordination in patients with multiple sclerosis.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High frequency repetitive transcranial magnetic stimulation | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 2 weeks after end of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 2 weeks after end of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of physical therapy, Cairo University | Giza | Dokki | 12612 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31901449 | Background | 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. | |
| 33641274 |
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Participant masking as patients will be divided into two groups High frequecy cerebellar repetitive transcranial magnetic stimulation and Sham repetitive transcranial magnetic stimulation by placing the coil in perpendicular way away from the cerebellum.
Care provider masking as the physical therapist treating patients will be blind from the application of repetitive transcranial magnetic stimulation
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| Sham repetitive transcranial magnetic stimulation | Device | 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 |
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| 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 | 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 | 2 weeks after end of treatment |
| Background |
| Aloizou 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. |
| 35669870 | Background | Somaa 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. |
| 40664092 | Derived | Mohamed 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. |