Cerebellar RTMS in Patients with Multiple Sclerosis

NCT06265922 | Completed

• 1 other identifier: P.T.REC/012/003937
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

To determine the efficacy of high frequency cerebellar repetitive transcranial magnetic stimulation on coordination in patients with multiple sclerosis.

Conditions

Patients with Multiple Sclerosis

Keywords

Patients with Multiple Sclerosis; Coordination; Transcranial magnetic stimulation

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Berg balance scale

  2 weeks after end of treatment

• Nine-Hole Peg Test (9-HPT)

  2 weeks after end of treatment

• Four square step test (FSST)

  2 weeks after end of treatment

Study Arms (2)

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

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

Device: Sham repetitive transcranial magnetic stimulation

Interventions

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.

Also known as: Hf-rTMS

High frequency cerebellar repetitive transcranial magnetic stimulation

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

Sham cerebellar repetitive transcranial magnetic stimulation

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Previous surgeries in the brain.
• Any magnetic or metallic devices implanted (like cochlear implants) .
• Psychotic deficits or history of epileptic seizures.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of physical therapy, Cairo University

Giza, Dokki, 12612, Egypt

Location

Related Publications (4)

• 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.

  PMID: 31901449 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.

  PMID: 33641274 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.

  PMID: 35669870 BACKGROUND

• 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.

  PMID: 40664092 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer

Study Record Dates

• First Submitted: February 11, 2024
• First Posted: February 20, 2024
• Study Start: February 18, 2024
• Primary Completion: July 17, 2024
• Study Completion: August 5, 2024
• Last Updated: February 19, 2025

Record last verified: 2024-02

Locations

EG (1)