Cerebellar High-Frequency rTMS in Balance of Multiple Sclerosis Patients

NCT ID: NCT06998810

Last Updated: 2025-05-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-25
• Study Completion Date: 2025-03-25

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.

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Arm 1: Active Comparator - Real rTMS

Arm Label: Real rTMS

Type: Active Comparator

Description:

Participants in this group receive real repetitive transcranial magnetic stimulation (rTMS) targeting the cerebellum. Stimulation is delivered using a figure-of-eight coil positioned over the vermis of the cerebellum, at a frequency of 10 Hz, work period 5s, number of trains 25, ITI is 25s. The total number of pulses is 1250 pulses per session.

Group Type: ACTIVE_COMPARATOR

cerebellar rTMS

Intervention Type: DEVICE

Non-invasive magnetic stimulation targeting the cerebellum using a figure of eight coil

Arm 2: Sham Comparator - Sham rTMS

Arm Label: Sham rTMS Type: Sham Comparator

Description:

Participants in this group receive sham stimulation using the same rTMS device and setup as the active group. The coil is adjusted to mimic the sound and feel of stimulation without delivering an effective magnetic pulse to the brain. Participants are blinded to their assignment to preserve study integrity.

Group Type: SHAM_COMPARATOR

cerebellar rTMS

Intervention Type: DEVICE

Non-invasive magnetic stimulation targeting the cerebellum using a figure of eight coil

Interventions

cerebellar rTMS

Non-invasive magnetic stimulation targeting the cerebellum using a figure of eight coil

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Patient age ≥18 years.
• Patients with MS, established by clinical, laboratory, MRI criteria and matched Mc Donald's criteria, McDonald et al, 2006.
• Expanded Disability Status Scale (EDSS) scores between 2.5-5
• Only patients in "remitting" phase were included.
• Informed consent.

Exclusion Criteria

• Factors that prevent patient cooperation understanding that impede proper study participation.
• Disabling medical history as severe or recent heart disease and or severe head trauma.
• Cognitive impairment: <24 points by mini-mental scale. (Folstein MF et al., 1975).
• Diabetic patients.
• Patients with any other comorbidity that can affect balance, e.g, other neurological diseases that can affect posterior column function.
• Contraindications for rTMS:

1. History of epilepsy.

2. Metal (implants) in skull/scalp/head or fragments from welding or metalwork.

3. Implanted device (as spinal cord stimulator, cardiac pacemaker, and cochlear implants).

4. Pregnancy.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Shereen Ismail Fawaz

Cairo, Other, Egypt

Countries

Egypt

Other Identifiers

FMASUREC

Identifier Type: OTHER

Identifier Source: secondary_id

FMASU R31/2023

Identifier Type: -

Identifier Source: org_study_id