Scrambler Therapy for Corticobasal Syndrome-Associated Pain — ST-CBS  

Pain, Neuropathic Clinical Trial

Official title: Scrambler Therapy for Corticobasal Syndrome-Associated Pain

Status Recruiting

Clinical Trial 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 central neuropathic pain.

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Corticobasal Degeneration
• Corticobasal Syndrome
• Neuralgia
• Pain, Neuropathic
• Syndrome

• NCT number: NCT05653778
• Study type: Interventional
• Source: Johns Hopkins University
• Contact: Alexander Pantelyat, MD
• Phone: 410-502-3290
• Email: apantel1@jhmi.edu
• Status: Recruiting
• Phase: N/A
• Start date: April 5, 2024
• Completion date: December 2026