Cerebellar High-Frequency rTMS in Balance of Multiple Sclerosis Patients

NCT06998810 | Completed

• 2 other identifiers: FMASU R31/2023FMASUREC
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Keywords

multiple sclerosis, cerebellar rTMS, balance in Multiple sclerosis,

Outcome Measures

Primary Outcomes (3)

• Static posturography

  Static Posturography: Balance assessment using COP measures under eyes-open (COP-O) and eyes-closed (COP-C) conditions.

  3 years

• International Cooperative Ataxia Rating Scale (ICARS)

  International Cooperative Ataxia Rating Scale (ICARS): Quantifies ataxia severity.

  3 years

• Expanded Disability Status Scale (EDSS)

  Expanded Disability Status Scale (EDSS): Overall disability in MS

  3 years

Secondary Outcomes (1)

• 10-Meter Walk Test (10MWT)

  3 years

Study Arms (2)

Arm 1: Active Comparator - Real rTMS

ACTIVE COMPARATOR

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.

Device: cerebellar rTMS

Arm 2: Sham Comparator - Sham rTMS

SHAM COMPARATOR

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.

Device: cerebellar rTMS

Interventions

cerebellar rTMS DEVICE

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

Arm 1: Active Comparator - Real rTMS; Arm 2: Sham Comparator - Sham rTMS

Eligibility Criteria

• Age: 18 Years - 60 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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:
• History of epilepsy.
• Metal (implants) in skull/scalp/head or fragments from welding or metalwork.
• Implanted device (as spinal cord stimulator, cardiac pacemaker, and cochlear implants).
• Pregnancy.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Shereen Ismail Fawaz

Cairo, Other, 11757, Egypt

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants are single-blinded to group assignment. Those in the active group receive real cerebellar rTMS, while the control group receives sham stimulation using an identical coil setup and sound, but without actual magnetic pulses. The treating clinician administering the rTMS is not blinded, but participants are unaware of their assignment to maintain blinding integrity.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A randomized, single-blinded, placebo-controlled prospective study was conducted at Ain Shams University Hospital. Forty MS patients were recruited from specialized MS clinics and physical medicine and Rehabilitation outpatient clinics. All patients signed and informed written consent. Patients were randomly assigned to one of two groups: Treatment Group (n = 20): received real rTMS over the cerebellar vermis, three times per week for 4 weeks. Control Group (n = 20): received sham rTMS using a placebo program. Both groups participated in an intensive exercise training program. An informed written consent was signed from all participants.

Study Record Dates

• First Submitted: May 6, 2025
• First Posted: May 31, 2025
• Study Start: February 25, 2023
• Primary Completion: December 25, 2024
• Study Completion: March 25, 2025
• Last Updated: May 31, 2025

Record last verified: 2025-05

Locations

EG (1)