Scrambler Therapy for Corticobasal Syndrome-Associated Pain
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?
| Condition(s) | Corticobasal Degeneration, Corticobasal Syndrome, Pain, Neuropathic |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | 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 |
| Who can participate | 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 ad |
| Ages | 50 Years to 89 Years |
| Sex | All |
| Lead sponsor | Johns Hopkins University |
| Locations | Baltimore, Maryland, United States |
| Start date | 2024-04-05 |
| NCT ID | NCT05653778 |
| Official listing | https://clinicaltrials.gov/study/NCT05653778 |