Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06579664
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-26
Brief Title:
Intermittent Theta Burst Stimulation on Cognitive Impairment of Cerebral Small Vessel Disease
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Intermittent Theta Burst Stimulation on Cognitive Impairment of Cerebral Small Vessel Disease
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
The cerebral small vessel diseasesCSVD 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 Parkinsons 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 11 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 157 days after randomization and 907 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
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 11 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 157 days after randomization and 907 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None