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 @ 3:00 PM
Ignite Modification Date:
2025-12-24 @ 3:00 PM
NCT ID:
NCT05612659
Eligibility Criteria:
Inclusion Criteria:
1. Subjects will include both male and female of age over 18 years and a BMI of 18-35 Kg/mts2 who have experienced stroke.
2. Moderately depressed, MADRS:18-28, PHQ9: 10-20 and/or experiencing cognitive impairments after stroke
Exclusion Criteria:
1. Current or lifetime bipolar disorder or schizophrenia diagnosis;
2. current (past month): PTSD, psychotic or substance use disorder (nicotine and caffeine allowed);
3. significant risk of suicide according to CSSRS or clinical judgment, or suicidal behavior in the past year:
4. current chronic severe pain conditions;
5. current chronic use of: opioids analgesics, medications that affect blood pressure or drugs with significant autonomic effects (stimulants and antipsychotics allowed if dose stable for 1 month);
6. skin lesions on electrode placement region;
7. implanted electrical medical devices;
8. Pregnancy;
9. suspected IQ\<80, and 10) any other clinically relevant reason as judged by the clinician.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT05612659
Study Brief:
Protocol Section:
NCT05612659