💬In plain words
What the trial is, and whether it could suit you
The goal of this pilot trial is to test whether scrambler therapy (ST) is an effective treatment for neuropathic pain in patients with corticobasal syndrome (CBS).
The main question it aims to answer is:
Will ST reduce pain scores by at least 33% at one month in this pilot trial, justifying further multi-center trials?
Participants will:
* be randomly assigned treatment from either transcutaneous electrical nerve stimulation (TENS) or ST for pain initially (eventually all patients will receive ST).
* have superficial electrocardiogram (ECG) electrodes placed on the dermatomes involved with pain
* obtain treatment lasting 30-40 minutes or until pain relief is obtained
Researchers will compare patient's response to pain relief with TENS and ST to determine if ST is an effective treatment for central neuropathic pain.
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
Inclusion Criteria:
* men and women, ≥50 years of age or older with CBS with an average daily pain rating of \> 4 out of 10, using the following question from the Brief Pain Inventory: "Please rate your pain by circling the one number that best describes your (abdominal) pain/discomfort on average over the past week. (Scale 0-10; 0= No pain, 10= Pain as bad as you can imagine)
* English speakers or English proficiency
* They must have a life expectancy \> 90 days per their treating neurologist.
* The patient must be able to understand the study regimen, its requirements, risks, and discomforts, and is able and willing to sign an informed consent form.
Exclusion Criteria:
* Pregnant women, nursing women, women of childbearing potential or their sexual partners who are unwilling to employ adequate contraception (condoms, diaphragm, birth control pills, injections, intrauterine device, surgical sterilization, subcutaneous implants, abstinence, etc.). Other exclusions include the following:
* Use of an investigational agent for pain control concurrently or within the past 30 days,
* History of an allergic reaction or previous intolerance to transcutaneous electronic nerve stimulation;
* Patients with implantable drug delivery systems, e.g. Medtronic Synchromed, baclofen pumps.
* Patients with heart stents or metal implants such as pacemakers, automatic defibrillators, cochlear implants, aneurysm clips, vena cava clips and skull plates. (Metal implants for orthopedic repair, e.g. pins, clips, plates, cages, joint replacements are allowed).
* Medical exclusions include: patients with a history of myocardial infarction or ischemic heart disease within the past six months; patients with history of epilepsy, brain damage, or symptomatic brain metastases; skin conditions such as open sores that would prevent proper application of the electrodes; or other medical or other condition(s) that in the opinion of the investigators might compromise the objectives of the study.
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