Exploring Sensations from Dorsal Root Stimulation
Sensory Responses to Dorsal Root Stimulation
University of Pittsburgh · NCT04725006
This study is testing how electrical stimulation of the spinal cord affects the sensations people with spinal cord stimulation devices feel.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | University of Pittsburgh (other) |
| Locations | 1 site (Pittsburgh, Pennsylvania) |
| Trial ID | NCT04725006 on ClinicalTrials.gov |
What this trial studies
This project aims to characterize the sensations evoked by electrical stimulation of the spinal cord and spinal nerves in patients with spinal cord stimulation devices. Participants will be recruited from a local pain clinic and will undergo experiments to assess the modulation of sensations in terms of modality, intensity, focality, and location. The study will utilize a custom stimulator system connected to spinal cord stimulator leads, and participants will report their sensations while detailed psychophysical metrics will be collected to evaluate their ability to discriminate between different sensations.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 70 who are participating in a clinical trial involving epidural spinal cord stimulation for pain management.
Not a fit: Patients with open wounds, implanted metal rods, defibrillators, pacemakers, or permanent skin metal tags may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of sensory feedback mechanisms and improve pain management strategies for patients with spinal cord stimulation.
How similar studies have performed: While the approach of using spinal cord stimulation is established, this specific investigation into sensory modulation through dorsal root stimulation is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Subjects must be between the ages of 18 and 70 years old. 2. Subjects must be undergoing an epidural spinal cord implanted electrode array clinical trial with Dr. Helm for the management of pain. 3. Persons must understand the consent and the procedures. Exclusion Criteria: 1. Persons with open wounds; 2. Persons with implanted metal rods in the spine or limbs; 3. Persons with defibrillator or pacemaker; 4. Persons with permanent skin metal tags or decorations.
Where this trial is running
Pittsburgh, Pennsylvania
- University of Pittsburgh — Pittsburgh, Pennsylvania, United States (RECRUITING)
Study contacts
- Principal investigator: Lee Fisher, PhD — University of Pittsburgh
- Study coordinator: Debbie Harrington
- Email: debbie.harrington@pitt.edu
- Phone: 412-383-1355
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Amputation, Sensation, Phantom, spinal cord stimulation, dorsal root ganglia stimulation, sensation, amputation, pain