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

Z

Zi-Xiao Li

Status

Enrolling

Conditions

Ischemic Stroke
Post-stroke Cognitive Impairment

Treatments

Device: iTBS group
Device: control group

Study type

Interventional

Funder types

Other

Identifiers

NCT06316557
HX-A-2022063

Details and patient eligibility

About

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.

Full description

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.

Enrollment

70 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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;

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

70 participants in 2 patient groups, including a placebo group

iTBS group
Experimental group
Description:
iTBS on the contralesional cerebellum
Treatment:
Device: iTBS group
control group
Placebo Comparator group
Description:
shame stimulation on the contralesional cerebellum
Treatment:
Device: control group

Trial contacts and locations

1

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Central trial contact

Weili Jia, Dr.

Data sourced from clinicaltrials.gov

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