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 @ 10:56 PM
Ignite Modification Date:
2025-12-24 @ 10:56 PM
NCT ID:
NCT05357469
Eligibility Criteria:
Inclusion Criteria:
1. \- Both genders aged 15-39 years
2. \- Patients who have CIPN associated with at least moderate symptoms of pain (≥4 on a 0-10 scale) or neuropathy.
3. \- Patients have had cancer and are not being actively treated,
4. \- Patients who speaks English and able to complete questionnaires by themselves or with help from parents and/or nurses. Written informed consent will be obtained from adults (aged 18-39 years) or from parents/guardians of adolescents (aged 15-17 years) and assent will be obtained from adolescents (aged 15-17 years) under an Institutional Review Board (IRB)-approved protocol.
Exclusion Criteria:
1. \- Inability to walk or stand without assistance (need for ambulatory-assist devices)
2. \- Bone and/or central nervous system metastases that affect gait, walking and balance
3. \- History of other known or unknown causes of acute or chronic neuropathic and/or no neuropathic pain conditions.
4. \- Implanted intrathecal drug-delivery system or a spinal cord and/or peripheral nerve stimulator;
a) a metal implant such as a cardiac pacemaker, automatic defibrillator, aneurysm clips, vena cava clips, or skull plate.
5. \- History of epilepsy.
6. \- Skin damage at the site of electrode placement; and i) prior ST treatment; j) Patients on pain medications for other than CIPN.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05357469
Study Brief:
Protocol Section:
NCT05357469