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:
2025-12-25 @ 2:31 AM
Ignite Modification Date:
2025-12-25 @ 2:31 AM
NCT ID:
NCT06536634
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of unilateral cerebral palsy/hemiparesis, following unilateral brain lesion, e.g. perinatal/childhood stroke (acquired prior to the age of 16 years)
* consistent and stable limitation of hand functions
* chronic state (time since lesion \>2 years)
* aged 6-18 years
* parental informed consent if \<14 years, informed consent of the patient if \>14 years
Exclusion criteria:
* psychiatric disease that prevents the participant form informed participation and compliance in an adequate manner/setting
* Bilateral brain lesion
* Recent Botulinum toxin-injections injections (UL, \< 6 months)
* Hand surgery on paretic hand \< 2 years
* Trauma to UL in the last year
* Medical conditions that prevent training of the UL
* Participation in other afferent stimulation studies
* Electrical stimulation therapy in the last 6 months
* Intensive training of the UL (therapy more than 1x/week, \< 6 months)
If MRI and TMS is performed, additionally:
• MRI and TMS contradictions, such as
* implanted Metal devices (e.g. braces, implant)
* implanted shunt system
* in girls and women: pregnancy
* claustrophobia
* Active epilepsy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
18 Years
Study:
NCT06536634
Study Brief:
Protocol Section:
NCT06536634