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 @ 2:40 AM
Ignite Modification Date:
2025-12-25 @ 2:40 AM
NCT ID:
NCT05571033
Eligibility Criteria:
Inclusion Criteria:
1. Age 18 and above
2. Diagnosis of spastic Cerebral Palsy
3. Gross Motor Function Classification System level I-III
4. Stable medical background
5. Current medication will remain unchanged for 3 months
6. Provides informed consent
7. can walk at least 10 meters with or without assistive device
8. meets minimum study procedure requirements (elicitation of H-reflex).
Exclusion Criteria:
1. Pregnancy
2. uncontrolled diabetes
3. weak dorsiflexion
4. History of cardiac conditions
5. cognitive deficits that interfere with study procedure and steps for completion
6. Botox within 2 months of the study
7. H/O ankle surgeries in affected leg (Dorsal root rhizotomy etc.)
8. regular use of electrical stimulation to lower extremity muscles
9. Cochlear or metal implantations on body
10. No history of seizure after age 2 years
11. Current use of antiseizure medicines
12. Any metal or magnetic components in the head (surgical clips, metal work etc.)
13. Implanted device or cardiac pacemakers (applicable for DS8R too)
14. Skin disorders
15. Damaged skin (wounds, broken skin, or recent scar tissue)
16. Allergy to latex (tape)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05571033
Study Brief:
Protocol Section:
NCT05571033