CI

At a glance

ClinicalIndex Comparison Record
N/AActive· 4 enrolled
Drug / intervention
Open-Loop DBS +2 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03029884
NCT03029884N/AActive

Technology Development for Closed-loop Deep Brain Stimulation to Treat Refractory Neuropathic Pain

Prasad Shirvalkar, MD, PhD·interventional·Posted Jan 24, 2017·Updated Apr 8, 2026

In Brief

A clinical study evaluating Open-Loop DBS, Sham Stimulation, and 1 other intervention for Chronic Pain and 3 related conditions. Active but no longer recruiting, targeting 4 participants across 1 site.

Detailed Summary

Deep brain stimulation (DBS) holds promise as a new option for patients suffering from treatment-resistant chronic pain, but current technology is unable to reliably achieve long-term pain symptom relief. A "one-size-fits-all" approach of continuous, 24/7 brain stimulation has helped patients with some movement disorders, but the key to reducing pain may be the activation of stimulation only when needed, as this may help keep the brain from adapting to stimulation effects. By expanding the technological capabilities of an investigative brain stimulation device, the investigators will enable the delivery of stimulation only when pain signals in the brain are high, and then test whether this more personalized stimulation leads to reliable symptom relief for chronic pain patients over extended periods of time.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/AActiveOverdue
2017201820192020202120222023202420252026
First PostedJan 24, 2017
Enrollment StartOct 28, 2017
Primary CompletionSep 30, 2023
Study CompletionJun 1, 2026
TodayJul 2, 2026
Enrollment to primary: 5.9 yearsPosted 9.4 years ago

Interventions

Open-Loop DBSdevice

Conventional brain stimulation that is tonically providing stimulation, without feedback

Sham Stimulationdevice

No Active Stimulation

Closed-Loop DBSdevice

Feedback enabled brain stimulation, where stimulation is provided on demand in response to pain biomarkers.