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 @ 2:28 AM
Ignite Modification Date:
2025-12-25 @ 2:28 AM
NCT ID:
NCT02722434
Eligibility Criteria:
Inclusion Criteria:
* Pain or symptoms of CIPN of \>= 3 months duration, for which the patient wants intervention
* Note: neurotoxic chemotherapy must have been completed \>= 3 months prior to registration and there must be no further planned neurotoxic chemotherapy for \> 5 months after registration
* Patients have to relate that tingling or pain was at least a four out of ten problem =\< 7 days prior to registration, on a 0-10 scale where zero was no problem and ten was the worst possible problem
* Note: the patient is expected to have tingling or pain of at least 4/10 at the time of the first treatment
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) = 0, 1, or 2
* Life expectancy \>= 6 months
* Ability to complete questionnaire(s) by themselves or with assistance
* Ability to provide informed written consent
* Case review by the study chair, or designate, as a case where treatment should be tried
Exclusion Criteria:
* Any of the following:
* Pregnant women
* Nursing women
* Women of childbearing potential who are unwilling to employ adequate contraception
* Existing operational implantable drug delivery systems, e.g. Medtronic Synchromed
* Existing implantable medical electronic devices, life-supporting medical devices, and medical monitoring devices
* Note: metal implants for orthopedic repair, e.g. pins, clips, plates, cages, joint replacements are allowed as are central venous access devices
* History of myocardial infarction or ischemic heart disease within the past six months
* History of epilepsy, brain damage, use of anticonvulsants for seizure prevention, concurrently using ketamine, symptomatic brain metastases
* Skin conditions such as open sores that would prevent proper application of the electrodes
* Other medical or other condition(s) that in the opinion of the investigators might compromise the objectives of the study
* Currently receiving gabapentin or pregabalin and not willing to be weaned off of these medications prior to Scrambler therapy initiation
* Note: it is OK to continue these medications in patients who are receiving TENS
* History of peripheral neuropathy prior to receiving neurotoxic chemotherapy
* Prior treatment with Scrambler therapy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02722434
Study Brief:
Protocol Section:
NCT02722434