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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Scrambler therapy
DeviceSuperficial electrocardiogram (ECG) electrodes are placed on the dermatomes involved with pain, above the area of pain itself. Each treatment lasts 30-40 minutes or until pain relief is obtained.
TENS treatment
DeviceSuperficial electrocardiogram (ECG) electrodes are placed on the dermatomes involved with pain, above the area of pain itself. Each treatment lasts 30-40 minutes or until pain relief is obtained.
Treatment groups
25 Participants
are divided into 2 treatment groupsGroup A: Scrambler therapyExperimental treatment 1 intervention
Group B: TENS treatmentActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in patient-reported average daily pain using the Modified Brief Pain Index
The primary objective is to determine the change in patient-reported average daily pain from Day 0 to Day 30 and 90 as measured on a numerical scale of 0-10 (0=no pain; 10=worst pain in life) using the Modified Brief Pain Index.
Time frame
Day 0 to Day 30 and 90Secondary outcomes
1
Change in patient-reported Global Impression of Change (PGIC)
Changes in the Patient Global Impression of Change score 1 to 7 with 1 representing no change and 7 representing "a great deal better"
Time frame
Day 0, Day 30 and Day 90Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov