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Completed

NCT Number: NCT06998810

Cerebellar High-Frequency rTMS in Balance of Multiple Sclerosis Patients

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shereen Ismail Fawaz

Cairo, Other, 11757, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • 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.

Treatment and study plan

Cerebellar rTMS

Device

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

Primary outcomes

  1. Static posturography

    Time frame: 3 years

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

  2. International Cooperative Ataxia Rating Scale (ICARS)

    Time frame: 3 years

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

  3. Expanded Disability Status Scale (EDSS)

    Time frame: 3 years

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

Secondary outcomes

  1. 10-Meter Walk Test (10MWT)

    Time frame: 3 years

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

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Effect of Cerebellar High-Frequency rTMS in Improving Balance Performance in Multiple Sclerosis Patients

Acronym: CRESTMS

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
May 31, 2025
Registry last updated
May 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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