Intermittent Theta Burst Stimulation on Cognitive Impairment of Cerebral Small Vessel Disease

NCT06579664 | Recruiting DMC

• 1 other identifier: HX-A-2024044
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Cerebral Small Vessel Diseases; Cognitive Impairment

Keywords

Cerebral Small Vessel Diseases; Cognitive Impairment; Intermittent Theta-Burst Stimulation; Personalized Brain Function Sector

Outcome Measures

Primary Outcomes (1)

• 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.

  at 90±7days after iTBS therapy

Secondary Outcomes (13)

• Change from baseline in Mini-mental State Examination

  at 90±7days after iTBS therapy

• Change from baseline in verbal fluency test

  at 90±7days after iTBS therapy

• Change from baseline in trail making test

  at 90±7days after iTBS therapy

• Change from baseline in Stroop Test

  at 90±7days after iTBS therapy

• Change from baseline in digital span test

  at 90±7days after iTBS therapy

Study Arms (2)

iTBS group

ACTIVE COMPARATOR

Device: iTBS

sham iTBS group

SHAM COMPARATOR

Device: sham iTBS

Interventions

iTBS DEVICE

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.

iTBS group

sham iTBS DEVICE

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.

sham iTBS group

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (1)

Beijing Tiantan Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Cerebral Small Vessel Diseases; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Weiqi Chen

CONTACT

010-59975029; weiqichen@aliyun.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This trial is a double-blind design using simulants to ensure blinding. Participants will be randomly assigned to the iTBS and sham group according to the randomization codes that were generated by a computer program.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Executive Vice-President

Model Details: 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.

Study Record Dates

• First Submitted: August 26, 2024
• First Posted: August 30, 2024
• Study Start: March 24, 2025
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 8, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)