Cerebellar High-Frequency rTMS in Balance of Multiple Sclerosis Patients

Not Applicable

Completed

• Conditions: Multiple Sclerosis

• Registration Number: NCT06998810
• Lead Sponsor: Ain Shams University

Brief Summary

Background: Multiple Sclerosis (MS) is a chronic autoimmune disease affecting the central nervous system (CNS), leading to progressive motor dysfunction and balance deficits. Objective: To investigate the impact of cerebellar rTMS in improving postural control, balance performance and functional ambulation in individuals with MS.

Forty patients were randomly assigned to receive repetitive transcranial magnetic stimulation (rTMS) over the cerebellum to improve motor function and balance in 40 MS patients. Outcome measures, including the Expanded Disability Status Scale (EDSS), static posturography (COP measures), the International Cooperative Ataxia Rating Scale (ICARS), and the 10-Meter Walk Test (10MWT), were assessed before and after intervention.

Detailed Description

Background: Multiple Sclerosis (MS) is a chronic autoimmune disease affecting the central nervous system (CNS), leading to progressive motor dysfunction and balance deficits. Although disease-modifying therapies have advanced, there remains an unmet need for effective treatments that target motor and cognitive impairments. Objective: To investigate the impact of cerebellar rTMS in improving postural control, balance performance, and functional ambulation in individuals with MS. Method: This randomized, single-blinded, placebo-controlled clinical trial evaluated the efficacy of repetitive transcranial magnetic stimulation (rTMS) over the cerebellum in improving motor function and balance in 40 MS patients. Outcome measures, including the Expanded Disability Status Scale (EDSS), static posturography (COP measures), the International Cooperative Ataxia Rating Scale (ICARS), and the 10-Meter Walk Test (10MWT), were assessed before and after intervention.

Study Timeline

• Study Start: 2023-02-25
• Primary Completion: 2024-12-25
• Study Completion: 2025-03-25
• Status Verified: 2025-05
• Study First Submitted: 2025-05-06
• Study First Submitted QC: 2025-05-22
• Last Update Submitted: 2025-05-22
• Study First Posted: 2025-05-31
• Last Update Posted: 2025-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Static posturography	3 years	Static Posturography: Balance assessment using COP measures under eyes-open (COP-O) and eyes-closed (COP-C) conditions.
International Cooperative Ataxia Rating Scale (ICARS)	3 years	International Cooperative Ataxia Rating Scale (ICARS): Quantifies ataxia severity.
Expanded Disability Status Scale (EDSS)	3 years	Expanded Disability Status Scale (EDSS): Overall disability in MS

Secondary Outcome Measures

Name	Time	Method
10-Meter Walk Test (10MWT)	3 years	put marks at 2, 6,\&8 meters. measure the time taken from 2 to 8 meters, neglect the rest

Trial Locations

Locations (1)

Shereen Ismail Fawaz; 🇪🇬 Cairo, Other, Egypt