Effect of High Frequency Cerebellar Repetitive Transcrani... | NCT07531797

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

NCT07531797

Sponsor

Ain Shams University

Status

Completed

Last Update Posted

Apr 15, 2026Actual

Enrollment

40Actual

Phase

Not Applicable

Conditions

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

Interventions

Repetitive Transcranial Magnetic Stimulation
Sham Repetitive Transcranial Magnetic Stimulation

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2023Actual

Primary Completion Date

Aug 30, 2024Actual

Completion Date

Dec 30, 2025Actual

First Submitted Date

Mar 29, 2026

First Submission Date that Met QC Criteria

Apr 13, 2026

First Posted Date

Apr 15, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 13, 2026

Last Update Posted Date

Apr 15, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

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.

Masking Info

Masking

Single

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.

Who Masked

Participant

ID	Term
D059345	Cerebral Small Vessel Diseases
D051346	Mobility Limitation

ID	Term
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D055909	Magnetic Field Therapy
D013812	Therapeutics