Effect of High Frequency Cerebellar Repetitive Transcranial Magnetic Stimulation on Functional Ambulation of Patients With Cerebral Small Vessel Disease

NCT07531797 | Completed

• 1 other identifier: FMASU MD96/2023
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Small Vessel Disease; Repetitive Transcranial Magnetic Stimulation (rTMS); Balance; Gait Disorders

Keywords

Repetitive Transcranial Magnetic Stimulation balance gait

Outcome Measures

Primary Outcomes (1)

• Timed Up and Go Test

  Time (in seconds) required to stand, walk 3 meters, turn, and sit

  Baseline, 6 weeks, 10 weeks

Study Arms (2)

Active rTMS

ACTIVE COMPARATOR

Participants in this group will receive active repetitive transcranial magnetic stimulation (rTMS) applied over the cerebellum according to the study protocol 1250 pulses, 10 hz frequency over the treatment period of 6 weeks

Device: Repetitive Transcranial Magnetic Stimulation

Sham rTMS

SHAM COMPARATOR

Participants in this group will receive sham stimulation that mimics the procedure of rTMS without delivering active magnetic stimulation, applied over the cerebellum for the same duration and frequency as the active group.

Device: Sham Repetitive Transcranial Magnetic Stimulation

Interventions

Repetitive Transcranial Magnetic Stimulation DEVICE

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.

Active rTMS

Sham Repetitive Transcranial Magnetic Stimulation DEVICE

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.

Sham rTMS

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams university

Cairo, Egypt

Location

MeSH Terms

Conditions

Cerebral Small Vessel Diseases; Mobility Limitation

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: March 29, 2026
• First Posted: April 15, 2026
• Study Start: May 1, 2023
• Primary Completion: August 30, 2024
• Study Completion: December 30, 2025
• Last Updated: April 15, 2026

Record last verified: 2026-04

Locations

EG (1)