An interventional study of Scrambler therapy and TENS treatment in Corticobasal Degeneration, Corticobasal Syndrome and Pain, Neuropathic, sponsored by Johns Hopkins University. Recruiting at 1 site in United States. Open to participants aged 50 Years to 89 Years. Per ClinicalTrials.gov, last updated 2026-01-13.
Sponsored by Johns Hopkins University · Not applicable, Interventional, and Treatment
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:
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.
Pain can be a common non-motor complication of corticobasal syndrome (CBS), which is a rare debilitating parkinsonian disorder that lacks disease-modifying therapies. Pain in CBS typically increases in severity as the disease progresses and adversely impacts quality of life (including sleep and daily function). Scrambler therapy is a non-invasive electrical approach to neuromodulation that sends "nonpain" information along the existing nerve pathways to modify peripheral and central sensitization with success in randomized controlled trials treating such difficult neuropathies as spinal cord stenosis, post-herpetic neuropathy and failed back syndrome; chemotherapy induced neuropathy; and neuromyelitis optica spectrum disorder (NMOSD). To date, four patients with CBS treated empirically with ST have experienced long lasting pain relief with treatment, suggesting a novel approach to a vexing symptom.
An estimated 35-80% of patients with Parkinson disease experience pain and it is highly likely that pain is more frequent in CBS, though estimates are lacking because CBS is a rare syndrome. This pain can be related to dystonia, musculoskeletal, radicular-peripheral neuropathic, and central neuropathic pain syndromes. Similar symptoms are found in patients with CBS. Currently, there are no FDA approved disease-modifying treatments. Although treatments for pain have been helpful, ultimately adjunct therapies are needed as the disease progresses. A simple, low-cost, non-invasive available treatment to reduce the pain of CBS is sorely needed. This pilot trial will provide data on which to design a larger randomized controlled trial.
Research Hypothesis: Scrambler Therapy (ST) will reduce pain scores by at least 33% at one month in this pilot trial, justifying further multi-center trials.
62 studies on the registry are indexed under Corticobasal Degeneration; 25 are open to participants now.
This study's planned enrollment of 25 is below the median of 56 across 25 interventional studies indexed under Corticobasal Degeneration.
Browse Corticobasal Degeneration studies →Johns Hopkins University is the lead sponsor of 1,783 studies on the registry; 313 are open to participants now.
Of its 203 completed or terminated interventional studies of FDA-regulated products, 140 (69%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Scrambler Therapy is a non-invasive neuromodulation approach using superficial electrocardiogram (ECG) electrodes in paired channels on the involved dermatomes to send "non-pain" information along the existing nerve pathways, which can modify peripheral and central sensitization.
Device: Scrambler therapy
Transcutaneous electrical nerve stimulation (TENS) is a battery-powered device which delivers low-voltage electrical current through superficial electrocardiogram (ECG) electrodes placed on the surface of the skin to provide pain relief.
Device: TENS treatment
Superficial 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.
Superficial 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.
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 90
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 90
Plan to share: No
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