Intermittent Theta Burst Stimulation on Cognitive Impairment of Cerebral Small Vessel Disease
NCT Number: NCT06579664
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cerebral Small Vessel Diseases|Cognitive Impairment
Interventions: DEVICE: iTBS|DEVICE: sham iTBS
Sponsor: Beijing Tiantan Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 58
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2026-03-31

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.

Primary Outcome Measures: 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 Outcome Measures: 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., 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., 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., 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., 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., 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., 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., 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., 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., 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., 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., 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., 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., at 15±7days and 90±7days after iTBS therapy