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

April 13, 2026 updated by: Noha Amr Eweis ElSayed, Ain Shams University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Ain shams university

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Active rTMS
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
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.
Sham Comparator: Sham rTMS
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Timed Up and Go Test
Time Frame: Baseline, 6 weeks, 10 weeks
Time (in seconds) required to stand, walk 3 meters, turn, and sit
Baseline, 6 weeks, 10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2023

Primary Completion (Actual)

August 30, 2024

Study Completion (Actual)

December 30, 2025

Study Registration Dates

First Submitted

March 29, 2026

First Submitted That Met QC Criteria

April 13, 2026

First Posted (Actual)

April 15, 2026

Study Record Updates

Last Update Posted (Actual)

April 15, 2026

Last Update Submitted That Met QC Criteria

April 13, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FMASU MD96/2023

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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