Cerebral Small Vessel DiseaseNCT07531797
Effect of High Frequency Cerebellar Repetitive Transcranial Magnetic Stimulation on Functional Ambulation of Patients With Cerebral Small Vessel Disease
A study testing Repetitive Transcranial Magnetic Stimulation in people with Cerebral Small Vessel Disease and Repetitive Transcranial Magnetic Stimulation (rTMS), run by Ain Shams University at 1 site in Egypt.
Trial 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). Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Cerebral Small Vessel Disease, Repetitive Transcranial Magnetic Stimulation (rTMS), Balance
- What is being tested?
- Repetitive Transcranial Magnetic Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2023to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Repetitive Transcranial Magnetic Stimulation, Sham Repetitive Transcranial Magnetic Stimulation
- Keywords
- Repetitive Transcranial Magnetic Stimulation balance gait
- Medical subject headings
- Cerebral Small Vessel Diseases, Mobility Limitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repetitive Transcranial Magnetic StimulationDevice
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 StimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Device: Sham Repetitive Transcranial Magnetic Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Timed Up and Go Test
Time (in seconds) required to stand, walk 3 meters, turn, and sit
Measured: Baseline, 6 weeks, 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2026
- Study start1 May 2023
- Primary completion30 Aug 2024
- Study completion30 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Small Vessel DiseaseStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noha Amr Eweis ElSayed, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07531797
- Sponsor's protocol ID
- FMASU MD96/2023
- Status last verified
- Apr 2026
- First submitted
- 29 Mar 2026
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of High Frequency Cerebellar Repetitive Transcranial Magnetic Stimulation on Functional Ambulation of Patients With Cerebral Small Vessel Disease
- ClinicalTrials.gov ID
- NCT07531797
- Acronym / sponsor ID
- FMASU MD96/2023
- Conditions
- Cerebral Small Vessel Disease, Repetitive Transcranial Magnetic Stimulation (rTMS), Balance, Gait Disorders
- Keywords
- Repetitive Transcranial Magnetic Stimulation balance gait
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 30 Aug 2024 (actual)
- Study completion
- 30 Dec 2025 (actual)
- First posted
- 15 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Active rTMS | Active comparator | Device: Repetitive Transcranial Magnetic StimulationParticipants 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 |
| Sham rTMS | Sham comparator | Device: Sham Repetitive Transcranial Magnetic StimulationParticipants 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. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (9 listed)
- 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,..
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Repetitive Transcranial Magnetic StimulationRepetitive 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. | Device | Active rTMS |
| Sham Repetitive Transcranial Magnetic StimulationSham 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. | Device | Sham rTMS |
Primary outcome
Timed Up and Go Test
Time frame: Baseline, 6 weeks, 10 weeks
Time (in seconds) required to stand, walk 3 meters, turn, and sit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Repetitive Transcranial Magnetic Stimulation in people with Cerebral Small Vessel Disease and Repetitive Transcranial Magnetic Stimulation (rTMS), run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Timed Up and Go Test (time frame: Baseline, 6 weeks, 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026.