Clinical trial NCT06998810: Cerebellar High-Frequency rTMS in Balance of Multiple Sclerosis Patients
Official title: Effect of Cerebellar High-Frequency rTMS in Improving Balance Performance in Multiple Sclerosis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: multiple sclerosis, cerebellar rTMS, balance in Multiple sclerosis,
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2025-05-31
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Static posturography
timeFrame: 3 years
measure: International Cooperative Ataxia Rating Scale (ICARS)
timeFrame: 3 years
measure: Expanded Disability Status Scale (EDSS)
timeFrame: 3 years
Secondary outcomes:
measure: 10-Meter Walk Test (10MWT)
timeFrame: 3 years
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Shereen Ismail Fawaz
state: Other
Study officials:
References: