Cerebellar RTMS in Patients with Multiple Sclerosis

Not Applicable

Completed

• Conditions: Patients with Multiple Sclerosis
• Interventions: Device: High frequency repetitive transcranial magnetic stimulation; Device: Sham repetitive transcranial magnetic stimulation

• Registration Number: NCT06265922
• Lead Sponsor: Cairo University

Brief Summary

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 Timeline

• Status Verified: 2024-02
• Study First Submitted: 2024-02-11
• Study First Submitted QC: 2024-02-11
• Study Start: 2024-02-18
• Study First Posted: 2024-02-20
• Primary Completion: 2024-07-17
• Study Completion: 2024-08-05
• Last Update Submitted: 2025-02-15
• Last Update Posted: 2025-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High frequency cerebellar repetitive transcranial magnetic stimulation	High frequency repetitive transcranial magnetic stimulation	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
Sham cerebellar repetitive transcranial magnetic stimulation	Sham repetitive transcranial magnetic stimulation	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

Primary Outcome Measures

Name	Time	Method
Biodex balance system	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)

Secondary Outcome Measures

Name	Time	Method
Berg balance scale	2 weeks after end of treatment	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)
Nine-Hole Peg Test (9-HPT)	2 weeks after end of treatment	Change of manual dexterity of both the dominant and non dominant hand from baseline to 2 weeks after the beginning of intervention
Four square step test (FSST)	2 weeks after end of treatment	Change of dynamic balance and coordination from baseline to 2 weeks after the beginning of intervention

Trial Locations

Locations (1)

Faculty of physical therapy, Cairo University; 🇪🇬 Giza, Dokki, Egypt