Scrambler Therapy for Corticobasal Syndrome-Associated Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-89
SponsorJohns Hopkins University
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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).
Trial design
Treatments tested in this trial
- Scrambler therapy
- TENS treatment
Treatment groups
25 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov