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Recruiting NCT06316557

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

No phase Interventional Post-stroke Cognitive Impairment Ischemic Stroke

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: iTBS group, control group.
Who it may be relevant to
Registry conditions: Post-stroke Cognitive Impairment, Ischemic Stroke. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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

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.

Interventions

  • Device iTBS group
    iTBS on the contralesional cerebellum, twice a day for seven days
  • Device control group
    shame stimulation on the contralesional cerebellum, twice a day for seven days

Primary outcome measures

  • The efficacy of improving cognitive function of post-stroke cognitive impairment [Time frame: 3 months follow-up after treatment]
Secondary outcome measures (1)
  • The safety of improving cognitive function of post-stroke cognitive impairment [Time frame: day1-day7]

Eligibility criteria

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;

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Beijing Tiantan hospital — Beijing

Identifiers

NCT: NCT06316557 · HX-A-2022063

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗