Balance, Cerebral Small Vessel Disease, Gait Disorders, Repetitive Transcranial Magnetic Stimulation (rTMS)
Conditions
Keywords
Repetitive Transcranial Magnetic Stimulation balance gait
Brief summary
This study aims to evaluate the effect of repetitive transcranial magnetic stimulation (rTMS) applied over the cerebellum on gait performance and balance in patients with cerebral small vessel disease (CSVD). CSVD is associated with impaired mobility and increased risk of falls, which can significantly affect functional independence and quality of life. Participants will be randomly assigned to receive either active cerebellar rTMS or sham stimulation over a defined treatment period. Gait and balance will be assessed using objective clinical measures, including the Timed Up and Go test (TUG) and the 10-Meter Walk Test (10MWT), at baseline, after the intervention, and during follow-up. The study aims to determine whether active cerebellar rTMS leads to greater improvement in motor function and mobility compared to sham stimulation in patients with CSVD.
Interventions
DEVICERepetitive Transcranial Magnetic Stimulation
Repetitive transcranial magnetic stimulation (rTMS) will be applied over the cerebellum using a magnetic coil (figure of eight coil)to deliver repetitive pulses at specified frequency (10 HZ) according to the study protocol.
DEVICESham Repetitive Transcranial Magnetic Stimulation
Sham repetitive transcranial magnetic stimulation will be applied over the cerebellum using a sham or inactive stimulation technique that mimics the procedure, sound, and sensation of active rTMS without delivering effective magnetic stimulation.
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Participants are blinded to group assignment. Individuals in the active rTMS and sham groups will undergo similar procedures to ensure that participants are unaware of the type of stimulation received. Care providers and investigators administering the intervention are not blinded.
Intervention model description
Participants will be randomly assigned to one of two parallel groups: an active rTMS group receiving cerebellar stimulation and a sham rTMS group receiving placebo stimulation. Each participant will receive the assigned intervention over the study period without crossover between groups. Outcomes will be assessed at baseline, immediately after the intervention, and at follow-up.
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients included aged 30 years or older. • Presenting with impaired gait DUE TO CSVD, Type I Arteriosclerosis-related CSVD (Hypertension, Diabetes). Or Type IV; Inflammatory/immunologically mediated CSVD: Systematic Vasculitis
Exclusion criteria
Moderate to severe cognitive impairment (excluded by mini mental state test) * Uncontrolled Diabetes mellites (HBA1C \> 7%) * Recent head trauma. * Mental disorders. * Other co-existing neurological disease as Multiple sclerosis, ALS,.. * Other causes of peripheral neuropathy (metabolic disorders, radiation induced, toxic, … etc) * Patients with acute stroke. * Any contraindications for rTMS as skull defects, epilepsy, brain implants, pacemaker or pregnancy. * Vasculitis secondary to CNS infections tuberculosis, syphilis, HIV, leptospirosis.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Timed Up and Go Test | Baseline, 6 weeks, 10 weeks | Time (in seconds) required to stand, walk 3 meters, turn, and sit |
Countries
Egypt
Outcome results
None listed