NCT06316557

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
11mo left

Started Jan 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress60%
Jan 2025Apr 2027

First Submitted

Initial submission to the registry

March 12, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 18, 2024

Completed
10 months until next milestone

Study Start

First participant enrolled

January 1, 2025

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2027

Last Updated

July 2, 2025

Status Verified

June 1, 2025

Enrollment Period

1.5 years

First QC Date

March 12, 2024

Last Update Submit

June 30, 2025

Conditions

Post-stroke Cognitive ImpairmentIschemic Stroke

Keywords

Post-stroke Cognitive ImpairmentRepetitive transcranial magnetic stimulationHigh-frequencyCerebellar

Outcome Measures

Primary Outcomes (1)

  • The efficacy of improving cognitive function of post-stroke cognitive impairment

    The change of MoCA between baseline and 3 months follow-up

    3 months follow-up after treatment

Secondary Outcomes (1)

  • The safety of improving cognitive function of post-stroke cognitive impairment

    day1-day7

Study Arms (2)

iTBS group

EXPERIMENTAL

iTBS on the contralesional cerebellum

Device: iTBS group

control group

PLACEBO COMPARATOR

shame stimulation on the contralesional cerebellum

Device: control group

Interventions

iTBS groupDEVICE

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

iTBS group
control groupDEVICE

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

control group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Tiantan hospital

Beijing, 100070, China

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Control Groups

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Zixiao LI, Dr.

    Beijing Tiantan Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Weili Jia, Dr.

CONTACT

+86 13120207987jiawl1994@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Multicenter Randomized Double-Blind Controlled Study
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

March 12, 2024

First Posted

March 18, 2024

Study Start

January 1, 2025

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

April 1, 2027

Last Updated

July 2, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)