Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:16 PM
Ignite Modification Date:
2025-12-24 @ 3:16 PM
NCT ID:
NCT05440292
Eligibility Criteria:
Inclusion Criteria:
1. patients with ischemic stroke;
2. Primary onset, non-lateral motor area stroke lesion, duration of disease 15 days to 1 year;
3. Hemiplegia with unilateral hemispheric injury;
4. Brunnstrom grading (Brunnstrom, 1966)≤ STAGE IV;
5. Unconscious disorder;
6. Can cooperate to complete scale assessment, MRI scan and TMS treatment;
7. Can complete manual tasks and obtain activation points in the lateral motor area of the healthy hemisphere;
8. The head movement amplitude of all fMRI images was translational \< 2mm and rotational \< 2°;
9. Consent to rTMS treatment on the basis of conventional treatment and pass TMS safety screening;
Exclusion Criteria:
1. Use of muscle relaxation drugs recently;
2. A history of epilepsy;
3. History of other neuropsychiatric diseases;
4. Other motor system diseases;
5. History of head trauma and serious heart disease;
6. Contraindications to MRI scanning (implantable pacemaker, cardiac catheter or electronic pump; Intracerebral metal aneurysm clip, metal nail or vascular suture device; Intracerebral nerve stimulator or brain/subdural electrode, etc.)
7. Skull defect was closed with metal plate at TMS stimulation site;
8. Patients with skull defect;
9. Other severe systemic diseases or clinical critical conditions (respiratory or hemodynamic instability);
10. Refuse to participate in the trial.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
35 Years
Maximum Age:
80 Years
Study:
NCT05440292
Study Brief:
Protocol Section:
NCT05440292