Cerebellar High-Frequency rTMS in Balance of Multiple Sclerosis Patients (CRESTMS)

Ain Shams University

Status: Completed

Conditions: Multiple Sclerosis

Treatments: Device: cerebellar rTMS

Study type: Interventional

Funder types: Other

Identifiers

NCT06998810

FMASU R31/2023

FMASUREC (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Arm 1: Active Comparator - Real rTMS

Active Comparator group

Description:

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.

Treatment:

Device: cerebellar rTMS

Arm 2: Sham Comparator - Sham rTMS

Sham Comparator group

Description:

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.

Treatment:

Device: cerebellar rTMS