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 @ 11:19 PM
Ignite Modification Date:
2025-12-24 @ 11:19 PM
NCT ID:
NCT05311956
Eligibility Criteria:
Inclusion Criteria:
Patients:
* Age ≥ 21 years
* Diagnosis of end stage kidney disease (OCD 18.6) and receiving hemodialysis
* Montreal Cognitive Assessment (MoCA-Blind) adjusted score of≥18;
* Pain for ≥3 months, with a self-reported pain intensity of ≥4 (on a 0-10 scale) during the week preceding the screening;
* Speaks English or Spanish
* Medically stable, as determined by clinician and defined as unlikely to undergo a substantial change in illness or treatment during the next 3 months
* Able to provide written informed consent.
Caregivers:
* Age ≥21 years
* Serves as primary caregiver for ESKD patient (e.g., partner, adult child, friend)
* Speaks English or Spanish
Exclusion Criteria:
* Active medical or major psychiatric illnesses that will impact pain or interfere with study procedures
* History of head trauma, seizure disorder, brain surgery, stroke, or cancer affecting head, metal implants in the head, or compromised skin integrity on the head in the area where electrodes will be placed
* Use of another neurostimulation device (such as spinal cord stimulator, cardio-stimulator implanted cardioverter-defibrillator)
* Not able to respond to brief questionnaires and rating scales that will interfere with study procedures
* Does not tolerate tDCS at a skin test (performed at training Visit 2)
* Does not provide informed consent
Exclusion criteria for all above groups:
\* Does not speak English or Spanish
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT05311956
Study Brief:
Protocol Section:
NCT05311956