ClinicalTrials.gg
CompletedNCT06998810CRESTMSUpdated May 31, 2025

Cerebellar High-Frequency rTMS in Balance of Multiple Sclerosis Patients

An interventional study of cerebellar rTMS in Multiple Sclerosis, sponsored by Ain Shams University. Completed at 1 site in Egypt. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2025-05-31.

Sponsored by Ain Shams University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 2 months after the study started (first participant enrolled Feb 2023, registered May 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Multiple Sclerosis

Browse trials for

Keywords

  • multiple sclerosis, cerebellar rTMS, balance in Multiple sclerosis,
03

In context

Multiple Sclerosis

3,524 studies on the registry are indexed under Multiple Sclerosis; 668 are open to participants now.

This study's enrollment of 40 is below the median of 50 across 2,386 interventional studies indexed under Multiple Sclerosis.

Browse Multiple Sclerosis studies →

Lead sponsor

Ain Shams University is the lead sponsor of 1,930 studies on the registry; 433 are open to participants now.

Of its 33 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
40 participants (actual)

Study arms

  • Active comparator
    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.

    Device: cerebellar rTMS

  • Sham comparator
    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.

    Device: cerebellar rTMS

Interventions

  • Devicecerebellar rTMS

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

06

What researchers measure

Primary outcomes

  1. Static posturography

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

    Time frame: 3 years

  2. International Cooperative Ataxia Rating Scale (ICARS)

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

    Time frame: 3 years

  3. Expanded Disability Status Scale (EDSS)

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

    Time frame: 3 years

Secondary outcomes

  1. 10-Meter Walk Test (10MWT)

    put marks at 2, 6,\&8 meters. measure the time taken from 2 to 8 meters, neglect the rest

    Time frame: 3 years

07

Study locations

1 site
  • Shereen Ismail Fawaz
    Cairo, Other 11757, Egypt
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 31, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06998810
Responsible party
Sponsor
First posted
May 31, 2025
Start date
Feb 25, 2023
Primary completion
Dec 25, 2024
Completion
Mar 25, 2025
Last update
May 31, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion