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Completed

NCT Number: NCT07531797

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

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.

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Key information

Conditions

Cerebral Small Vessel Disease Balance Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebral Small Vessel Diseases Cerebrovascular Disorders Gait Disorders Mobility Limitation Nervous System Diseases Pathological Conditions, Signs and Symptoms Repetitive Transcranial Magnetic Stimulation (rTMS) Signs and Symptoms Vascular Diseases

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ain Shams university

Cairo, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Timed Up and Go Test

    Time frame: Baseline, 6 weeks, 10 weeks

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

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Apr 15, 2026
Registry last updated
Apr 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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