HOPE From the Cerebellum: TMS-Induced Cognitive Recovery After Stroke

NCT ID: NCT06316557

Last Updated: 2025-07-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-01

Study Completion Date

2027-04-01

Brief Summary

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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.

Detailed Description

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The primary objective of this clinical trial is to investigate the effectiveness and safety of intermittent theta burst stimulation ( iTBS) in the cerebellum for individuals with post-stroke cognitive impairment. The trial aims to answer two main questions: (1) What is the effectiveness of iTBS in improving post-stroke cognitive impairment? (2) Is iTBS in the cerebellum safe for individuals with post-stroke cognitive impairment? Participants will undergo iTBS in the cerebellar opposite the lesion site, twice daily for five days. The control group will receive sham rTMS with the same parameters and positions.

Conditions

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Post-stroke Cognitive Impairment Ischemic Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Multicenter Randomized Double-Blind Controlled Study
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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iTBS group

iTBS on the contralesional cerebellum

Group Type EXPERIMENTAL

iTBS group

Intervention Type DEVICE

iTBS on the contralesional cerebellum, twice a day for seven days

control group

shame stimulation on the contralesional cerebellum

Group Type PLACEBO_COMPARATOR

control group

Intervention Type DEVICE

shame stimulation on the contralesional cerebellum, twice a day for seven days

Interventions

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iTBS group

iTBS on the contralesional cerebellum, twice a day for seven days

Intervention Type DEVICE

control group

shame stimulation on the contralesional cerebellum, twice a day for seven days

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

(1)ischemic stroke, with an initial incident occurring within 2 weeks;(2)MoCA\<26;

Exclusion Criteria

(1)Cerebral hemorrhage or subarachnoid hemorrhage;(2)A pre-existing history of epilepsy;
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zi-Xiao Li

OTHER

Sponsor Role lead

Responsible Party

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Zi-Xiao Li

Dr.

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Zixiao LI, Dr.

Role: PRINCIPAL_INVESTIGATOR

Beijing Tiantan Hospital

Locations

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Beijing Tiantan hospital

Beijing, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Weili Jia, Dr.

Role: CONTACT

+86 13120207987

Facility Contacts

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Weili Jia

Role: primary

+86 13120207987

Other Identifiers

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HX-A-2022063

Identifier Type: -

Identifier Source: org_study_id

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