Multiple Sclerosis
Conditions
Keywords
multiple sclerosis, cerebellar rTMS, balance in Multiple sclerosis,
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.
Interventions
DEVICEcerebellar rTMS
Non-invasive magnetic stimulation targeting the cerebellum using a figure of eight coil
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
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.
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Expanded Disability Status Scale (EDSS) | 3 years | Expanded Disability Status Scale (EDSS): Overall disability in MS |
| Static posturography | 3 years | Static Posturography: Balance assessment using COP measures under eyes-open (COP-O) and eyes-closed (COP-C) conditions. |
| International Cooperative Ataxia Rating Scale (ICARS) | 3 years | International Cooperative Ataxia Rating Scale (ICARS): Quantifies ataxia severity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 10-Meter Walk Test (10MWT) | 3 years | put marks at 2, 6,&8 meters. measure the time taken from 2 to 8 meters, neglect the rest |
Countries
Egypt
Outcome results
None listed