Cerebral Small Vessel DiseasesNCT06579664
Intermittent Theta Burst Stimulation on Cognitive Impairment of Cerebral Small Vessel Disease
A study testing iTBS in people with Cerebral Small Vessel Diseases and Cognitive Impairment, run by Beijing Tiantan Hospital at 1 site in China.
Trial summary
The cerebral small vessel diseases (CVSD) can cause severe and lasting damage to cognition function while the current available treatment of vascular cognitive impairment (VCI) is limited. Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Cerebral Small Vessel Diseases, Cognitive Impairment
- What is being tested?
- iTBS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 1 siteChina
- Study dates
- 24 Mar 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 45-80 years old, with no limitation on sex.
- Clinical evidence of CVSD as evidenced by one or more of:
- White matter hyperintensity with Fazekas score ≥2
- a lacunar stroke syndrome (e.g. pure motor stroke, pure sensory stroke, sensorimotor stroke, ataxic hemiparesis, or clumsy hand dysarthria syndrome) with a corresponding acute lacunar infarct on diffusion weighted imaging (DWl) for cases imaged (clinically) within 3 weeks of stroke or anatomically compatible lacunar infarct on fluid attenuated inversion recovery (FLAIR)/T1 MRI for cases imaged later after stroke (diameter≤1.5cm).
- Independence of daily life (modified Rankin Scale score ≤2).
- Mild vascular cognitive impairment (memory and/or other cognitive domain abnormalities lasting for at least 3 months) with a MoCA score of 10-22.
- Routine, consistent medication for 4 weeks or more.
Who cannot join
- History of stroke within previous 30 days, including cerebral infarction (diameter >15mm), cerebral hemorrhage, subarachnoid hemorrhage;
- History of cerebral cortex infarction.
- History of cerebrovascular malformation or aneurysmal subarachnoid hemorrhage, or discovery of an untreated aneurysm > 3mm.
- Carotid or vertebral artery stenosis > 50% measured on North American Symptomatic Carotid Endarterectomy Trial (NASCET) criteria.
- Possible amyloid cerebrovascular disease with at least 2 lobar hemorrhagic lesions (i.e., intracranial hemorrhage, cerebral microbleeds (CMB), cortical superficial siderosis, or convexal subarachnoid hemorrhage) measured on Boston Criteria 2.0; Or at least one lobar hemorrhagic lesion and at least one white matter feature (severe enlarged perivascular space in the centrum semiovale or multiple punctate white matter hyperintensities) without deep hemorrhagic lesion (cerebral hemorrhage or CMB) on T2* weighted MRI.
- Recorded diagnosis of neurodegenerative diseases (e.g. Alzheimer's disease and Parkinson's disease).
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- Definite non-vasogenic white matter lesions (e.g. multiple sclerosis, cortical dysplasia in adults, metabolic encephalopathy).
- Other psychiatric disorders diagnosed measured on the Diagnostic and Statistical Manual of Mental Disorders - V (DSM-V) diagnostic criteria; Or apparent suicidal intent.
- Unable to tolerate MRI or contraindication to MRI (e.g., claustrophobia).
- T1 or T2 weighted MRI shows focal brain injury.
- Patients or first-degree relatives with a history of seizures.
- Implanted pacemakers, vagus nerve stimulators, deep brain stimulators, or other metal medical devices.
- Received transcranial magnetic stimulation therapy within previous 3 months.
- Severe organic diseases with expected survival time <5 years, such as malignant tumor.
- Women of child bearing potential, pregnant or breastfeeding.
- Individual who have difficulty communicating verbally to the extent that they are unable to communicate, understand or follow instructions normally, and are unable to cooperate with treatment and evaluation.
- Combined with alcohol and drug abuse history.
- Unable to be cooperative and complete the follow-up due to geographical or other reasons.
- Participated in other clinical trials.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Tiantan Hospital
Beijing
Yilong Wang, 0086-010-59975029, yilong528@aliyun.com
About this study
The cerebral small vessel diseases (CVSD) can cause severe and lasting damage to cognition function while the current available treatment of vascular cognitive impairment (VCI) is limited. The purpose of this study is to explore the feasibility, safety, and efficacy of intermittent Theta Burst Stimulation (iTBS) on cognitive impairment of cerebral small vessel disease.
Read the detailed description
The cerebral small vessel diseases(CSVD) refers to any pathologic process that damages small end arteries, arterioles, venules, and brain capillaries. CVSD can cause severe and lasting damage to cognition function while the current available treatment of vascular cognitive impairment (VCI) is limited. Repetitive transcranial magnetic stimulation, a noninvasive neuromodulation treatment, has been proven effective for various neurological diseases such as depression, Parkinson's disease, poststroke movement disorders, and cognitive impairment. Theta-burst stimulation (TBS) has recently attracted broad attention as a form of accelerated repetitive transcranial magnetic stimulation that is more effective in achieving similar or higher therapeutic effects than conventional repetitive transcranial magnetic stimulation. The intermittent TBS (iTBS) has been considered to enhance cortical excitability. Personalized Brain Function Sector (pBFS) is a method that accurately delineate whole-brain personalized functional networks utilizing resting-state functional magnetic resonance imaging (MRI). The purpose of this study is to explore the efficacy and safety of iTBS under the guidance of pBFS in improving cognitive function in patients with CSVD.
This trial was a randomized, single-center, double-blind, sham-controlled parallel trial. The trial planned to enroll 58 patients with clinical evidence of CVSD and cognitive impairment, aged 45-85 years.
Participants were randomly assigned to receive iTBS stimulation or sham stimulation for 3 weeks in 1:1 ratio.
iTBS group: iTBS stimulation to the left dorsolateral prefrontal cortex (DLPFC), 1800 pulses /session, 4 sessions /day, as well as standard treatment and management according to the related guidelines.
sham iTBS group: mimicked iTBS stimulation at the same stimulation parameters, dose, and duration as the iTBS group with a sham coil, as well as standard treatment and management according to the related guidelines.
Follow up: Face to face interviews will be made on baseline, 15±7 days after randomization and 90±7 days after iTBS intervention.
The score of Montreal Cognitive Assessment Scale (MoCA) 90 days after iTBS intervention will be tested by the t-test or the Wilcoxon rank-sum test. The change of MoCA between baseline and 90 days after iTBS intervention will be tested by the two-sample t-test or the Mann-Whitney U test.
- Being tested
- iTBS, sham iTBS
- Keywords
- Cerebral Small Vessel Diseases, Cognitive Impairment, Intermittent Theta-Burst Stimulation, Personalized Brain Function Sector
- Medical subject headings
- Cerebral Small Vessel Diseases, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iTBSDevice
Participants in active group will receive iTBS stimulation in 50-Hz triplets at 5 Hz for 600 seconds per session (2 seconds on and 8 seconds off) at 90% of their resting motor threshold to the left dorsolateral prefrontal cortex (DLPFC).Each intervention day includes 4 sessions (1800 pulses/session) of stimulation delivering a total of 7200 active pulses. This treatment protocol will be conducted 15 consecutive days.
sham iTBSDevice
Participants in the sham group will receive sham iTBS stimulation, which will use the same stimulation parameters, dosage, and duration as the active group, but will employ a sham coil. The sham coil is identical in appearance to the real stimulus coil and simulate the sound of a real stimulus, but do not produce a real stimulus.
| Study group | Role | What they receive |
|---|---|---|
| iTBS group | Active comparator | Not described Receives: Device: iTBS |
| sham iTBS group | Sham comparator | Not described Receives: Device: sham iTBS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Montreal Cognitive Assessment Scale
Montreal Cognitive Assessment Scale (Beijing Edition) scores from 0 to 30. A higher score indicates better cognitive function.
Measured: at 90±7days after iTBS therapy
Secondary outcomes (13)
Change from baseline in Mini-mental State Examination
Mini-mental State Examination (MMSE) scores from 0 to 30. A higher score indicates better cognitive function.
Measured: at 90±7days after iTBS therapy
Change from baseline in verbal fluency test
Scoring of verbal fluency test (VFT) is based on the number of words produced by the participants from a category in a given time. A higher score indicates better cognitive function.
Measured: at 90±7days after iTBS therapy
Change from baseline in trail making test
Scoring of color trial test (CTT) is based on time taken to complete the test and the number of wrong answers. Shorter the test time and less the mistakes, the better the outcome.
Measured: at 90±7days after iTBS therapy
Change from baseline in Stroop Test
Scoring of Stroop Test is based on time taken to complete the test and the number of wrong answers. Shorter the test time and less the mistakes, the better the outcome.
Measured: at 90±7days after iTBS therapy
Change from baseline in digital span test
Digital span test scores from 0 to 24. A higher score indicates better cognitive function.
Measured: at 90±7days after iTBS therapy
Change from baseline in Hamilton Anxiety Scale
Hamilton Anxiety Scale (HAMA) scores from 0 to 56. A lower score indicates better emotional state.
Measured: at 15±7days and 90±7days after iTBS therapy
Change from baseline in Hamilton Depression Scale
Hamilton Depression Scale (HAMD) scores from 0 to 68. A lower score indicates better emotional state.
Measured: at 15±7days and 90±7days after iTBS therapy
Change from baseline in Pittsburgh sleep quality index
Pittsburgh sleep quality index (PSQI) scores from 0 to 21. A lower score indicates better sleep quality.
Measured: at 15±7days and 90±7days after iTBS therapy
Change from baseline in The Short Physical Performance Battery(SPPB)
SPPB scores from 0 to 12. A higher score indicates better motor ability.
Measured: at 15±7days and 90±7days after iTBS therapy
Change from baseline in The 5-level EuroQol five Dimensions Questionnaire
The 5-level EuroQol five Dimensions Questionnaire (EQ-5D-5L) scores from 0 to 25. A lower score indicates better life quality.
Measured: at 15±7days and 90±7days after iTBS therapy
Change from baseline in 6 meter walk test
Scoring of 6 meter walk test is based on time taken to complete the test. A lower score indicates better motor ability.
Measured: at 15±7days and 90±7days after iTBS therapy
Change from baseline in step-by-step walk test
Step-by-step walk test scores from 0 to 8. A lower score indicates better motor ability.
Measured: at 15±7days and 90±7days after iTBS therapy
Change from baseline in 3-dimensional gait analysis (3D-IGA)
Gait features can be assessed with 3D-IGA providing rhythm, pace, phases, joint angle and other quantitative indicators.
Measured: at 15±7days and 90±7days after iTBS therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2024
- Study start24 Mar 2025
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Small Vessel DiseasesStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe 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
- This trial was a randomized, single-center, double-blind, sham-controlled parallel trial. Participants were randomly assigned to receive iTBS stimulation or sham stimulation for 3 weeks in 1:1 ratio.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, yilong Wang, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06579664
- Sponsor's protocol ID
- HX-A-2024044
- Status last verified
- Sep 2025
- First submitted
- 26 Aug 2024
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intermittent Theta Burst Stimulation on Cognitive Impairment of Cerebral Small Vessel Disease
- ClinicalTrials.gov ID
- NCT06579664
- Acronym / sponsor ID
- HX-A-2024044
- Keywords
- Cerebral Small Vessel Diseases, Cognitive Impairment, Intermittent Theta-Burst Stimulation, Personalized Brain Function Sector
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 24 Mar 2025 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 30 Aug 2024 (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.
The cerebral small vessel diseases (CVSD) can cause severe and lasting damage to cognition function while the current available treatment of vascular cognitive impairment (VCI) is limited. The purpose of this study is to explore the feasibility, safety, and efficacy of intermittent Theta Burst Stimulation (iTBS) on cognitive impairment of cerebral small vessel disease.
Detailed description
The cerebral small vessel diseases(CSVD) refers to any pathologic process that damages small end arteries, arterioles, venules, and brain capillaries. CVSD can cause severe and lasting damage to cognition function while the current available treatment of vascular cognitive impairment (VCI) is limited. Repetitive transcranial magnetic stimulation, a noninvasive neuromodulation treatment, has been proven effective for various neurological diseases such as depression, Parkinson's disease, poststroke movement disorders, and cognitive impairment. Theta-burst stimulation (TBS) has recently attracted broad attention as a form of accelerated repetitive transcranial magnetic stimulation that is more effective in achieving similar or higher therapeutic effects than conventional repetitive transcranial magnetic stimulation. The intermittent TBS (iTBS) has been considered to enhance cortical excitability. Personalized Brain Function Sector (pBFS) is a method that accurately delineate whole-brain personalized functional networks utilizing resting-state functional magnetic resonance imaging (MRI). The purpose of this study is to explore the efficacy and safety of iTBS under the guidance of pBFS in improving cognitive function in patients with CSVD.
This trial was a randomized, single-center, double-blind, sham-controlled parallel trial. The trial planned to enroll 58 patients with clinical evidence of CVSD and cognitive impairment, aged 45-85 years.
Participants were randomly assigned to receive iTBS stimulation or sham stimulation for 3 weeks in 1:1 ratio.
iTBS group: iTBS stimulation to the left dorsolateral prefrontal cortex (DLPFC), 1800 pulses /session, 4 sessions /day, as well as standard treatment and management according to the related guidelines.
sham iTBS group: mimicked iTBS stimulation at the same stimulation parameters, dose, and duration as the iTBS group with a sham coil, as well as standard treatment and management according to the related guidelines.
Follow up: Face to face interviews will be made on baseline, 15±7 days after randomization and 90±7 days after iTBS intervention.
The score of Montreal Cognitive Assessment Scale (MoCA) 90 days after iTBS intervention will be tested by the t-test or the Wilcoxon rank-sum test. The change of MoCA between baseline and 90 days after iTBS intervention will be tested by the two-sample t-test or the Mann-Whitney U test.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This trial was a randomized, single-center, double-blind, sham-controlled parallel trial. Participants were randomly assigned to receive iTBS stimulation or sham stimulation for 3 weeks in 1:1 ratio.
| Arm | Type | Receives |
|---|---|---|
| iTBS group | Active comparator | Device: iTBS |
| sham iTBS group | Sham comparator | Device: sham iTBS |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 45-80 years old, with no limitation on sex.
- Clinical evidence of CVSD as evidenced by one or more of:
- Independence of daily life (modified Rankin Scale score ≤2).
- Mild vascular cognitive impairment (memory and/or other cognitive domain abnormalities lasting for at least 3 months) with a MoCA score of 10-22.
- Routine, consistent medication for 4 weeks or more.
Key exclusion criteria (19 listed)
- History of stroke within previous 30 days, including cerebral infarction (diameter >15mm), cerebral hemorrhage, subarachnoid hemorrhage;
- History of cerebral cortex infarction.
- History of cerebrovascular malformation or aneurysmal subarachnoid hemorrhage, or discovery of an untreated aneurysm > 3mm.
- Carotid or vertebral artery stenosis > 50% measured on North American Symptomatic Carotid Endarterectomy Trial (NASCET) criteria.
- Possible amyloid cerebrovascular disease with at least 2 lobar hemorrhagic lesions (i.e., intracranial hemorrhage, cerebral microbleeds (CMB), cortical superficial siderosis, or convexal subarachnoid hemorrhage) measured on Boston Criteria 2.0; Or at least one lobar hemorrhagic lesion and at least one white matter feature (severe enlarged perivascular space in the centrum semiovale or multiple punctate white matter hyperintensities) without deep hemorrhagic lesion (cerebral hemorrhage or CMB) on T2* weighted MRI.
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 |
|---|---|---|
| iTBSParticipants in active group will receive iTBS stimulation in 50-Hz triplets at 5 Hz for 600 seconds per session (2 seconds on and 8 seconds off) at 90% of their resting motor threshold to the left dorsolateral prefrontal cortex (DLPFC).Each intervention day includes 4 sessions (1800 pulses/session) of stimulation delivering a total of 7200 active pulses. This treatment protocol will be conducted 15 consecutive days. | Device | iTBS group |
| sham iTBSParticipants in the sham group will receive sham iTBS stimulation, which will use the same stimulation parameters, dosage, and duration as the active group, but will employ a sham coil. The sham coil is identical in appearance to the real stimulus coil and simulate the sound of a real stimulus, but do not produce a real stimulus. | Device | sham iTBS group |
Primary outcome
Change from baseline in Montreal Cognitive Assessment Scale
Time frame: at 90±7days after iTBS therapy
Montreal Cognitive Assessment Scale (Beijing Edition) scores from 0 to 30. A higher score indicates better cognitive function.
13 secondary outcomes
Change from baseline in Mini-mental State Examination
Time frame: at 90±7days after iTBS therapy
Change from baseline in verbal fluency test
Time frame: at 90±7days after iTBS therapy
Change from baseline in trail making test
Time frame: at 90±7days after iTBS therapy
Change from baseline in Stroop Test
Time frame: at 90±7days after iTBS therapy
Change from baseline in digital span test
Time frame: at 90±7days after iTBS therapy
Change from baseline in Hamilton Anxiety Scale
Time frame: at 15±7days and 90±7days after iTBS therapy
Change from baseline in Hamilton Depression Scale
Time frame: at 15±7days and 90±7days after iTBS therapy
Change from baseline in Pittsburgh sleep quality index
Time frame: at 15±7days and 90±7days after iTBS therapy
Change from baseline in The Short Physical Performance Battery(SPPB)
Time frame: at 15±7days and 90±7days after iTBS therapy
Change from baseline in The 5-level EuroQol five Dimensions Questionnaire
Time frame: at 15±7days and 90±7days after iTBS therapy
Change from baseline in 6 meter walk test
Time frame: at 15±7days and 90±7days after iTBS therapy
Change from baseline in step-by-step walk test
Time frame: at 15±7days and 90±7days after iTBS therapy
Change from baseline in 3-dimensional gait analysis (3D-IGA)
Time frame: at 15±7days and 90±7days after iTBS therapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iTBS in people with Cerebral Small Vessel Diseases and Cognitive Impairment, run by Beijing Tiantan Hospital at 1 site in China.
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 7 inclusion and 19 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: looking for participants now, as of the sponsor's last update on 8 Sep 2025. 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 China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Weiqi Chen (010-59975029, weiqichen@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Montreal Cognitive Assessment Scale (time frame: at 90±7days after iTBS therapy). 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 8 Sep 2025.