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NCT06316557 Clinical Trial

High-frequency rTMS on the Cerebellar to Improve Post-stroke Cognitive Impairment

Ischemic Stroke Clinical Trial

— HOPE  

Official title:
High-frequency Repetitive Transcranial Magnetic Stimulation on the Cerebellar Hemisphere to Improve Post-stroke Cognitive Impairment

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06316557
Other study ID # HX-A-2022063
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date April 1, 2024
Est. completion date April 1, 2027

Study information
Verified date March 2024
Source Beijing Tiantan Hospital
Contact Weili Jia, Dr.
Phone 13120207987
Email jiawl1994@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The objective of this clinical trial is to investigate the effectiveness and safety of repetitive transcranial magnetic stimulation (rTMS) in the cerebellum for individuals with post-stroke cognitive impairment. Participants will undergo rTMS in the cerebellar hemisphere opposite the lesion site, once daily for a total of five days.

Description:

The primary objective of this clinical trial is to investigate the effectiveness and safety of high-frequency repetitive transcranial magnetic stimulation (rTMS) in the cerebellum for individuals with post-stroke cognitive impairment. The trial aims to answer two main questions: (1) What is the effectiveness of high-frequency rTMS in improving post-stroke cognitive impairment? (2) Is high-frequency rTMS in the cerebellum safe for individuals with post-stroke cognitive impairment? Participants will undergo 5Hz rTMS in the cerebellar opposite the lesion site, once daily for a total of five days. The control group will receive sham rTMS with the same parameters and positions. By comparing the effectiveness of rTMS for post-stroke cognitive impairment between the two groups, researchers will assess the potential benefits of rTMS.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 70
Est. completion date April 1, 2027
Est. primary completion date July 1, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Key inclusion criteria: (1)ischemic stroke, with an initial incident occurring within 2 weeks;(2)MoCA<26; Key exclusion criteria: (1)Cerebral hemorrhage or subarachnoid hemorrhage;(2)A pre-existing history of epilepsy;

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• rTMS group
5Hz rTMS in lesion contralateral cerebellar hemisphere, once a day for a total of five days
• control group
shame rTMS in lesion contralateral cerebellar hemisphere, once a day for a total of five days

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Beijing Tiantan Hospital

Outcome
Type Measure Description Time frame Safety issue
Primary The efficacy of rTMS in improving cognitive function of post-stroke cognitive impairment The change of MoCA between baseline and 3 months follow-up 3 months follow-up after rTMS treatment
Secondary The safety of rTMS in improving cognitive function of post-stroke cognitive impairment Incidence of epilepsy during rTMS treatment day1-day7
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