Insula Neuromodulation for Chronic Neuropathic Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversity of Virginia
About this trial
This study will comprehensively investigate the insula as a brain target for neuromodulation to treat chronic neuropathic pain.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Men and women, between 18 and 80 years, inclusive
Subjects who are able and willing to give consent and able to attend all study visits
chronic with ≥6 month duration
severe is defined as: 'average' NPRS score of ≥ 5 out of 10 at current visit and the subject reports having a similar level of pain for at least the past two months
Disqualifiers
Fibromyalgia syndrome
temporomandibular joint disorders
irritable bowel syndrome
chronic headaches
Trial design
Design model
Crossover
Treatments tested in this trial
neuromodulation
DeviceDuring the inpatient phase of the study, insular mapping will be performed with electrical stimulation to implanted SEEG electrodes in order to optimize the region for trial stimulation. Subjects who respond favorably to trial stimulation in the hospital, will progress to the outpatient clinical trial phase where a DBS system will be implanted. All subjects will be blindly randomized to 3 months of stimulation and 3 months of sham stimulation.
Treatment groups
12 Participants
are divided into 2 treatment groupsGroup A: ControlSham comparator 1 intervention
Group B: DBS of the insulaActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Adverse events
Adverse event reporting will be collected throughout the study period. This will include neurological assessments by the study team postoperatively using the NIH Stroke Scale, MR imaging of implanted electrodes, comprehensive assessment of mood and cognition by a licensed psychologist, and vigilance for suicide with the asQ Screening Tool.
Time frame
Entire study period from enrollment through 6 months post DBS implantation2
Pain intensity
The primary efficacy outcome measure compares the change in pain intensity, as rated by the blinded subjects using the Numeric Pain Rating Scale (NPRS), between bilateral DBS of the insula and sham stimulation. The NPRS is an 11 point scale where 0 represents "no pain" and 10 represents the "worst possible pain." Clinical pain severity will be assessed daily in the home environment with a 7-day Ecological Momentary Assessment (NPRS rating) aggregated across days. The analysis will focus on DBS-ON Week 12 data relative to the DBS-OFF (Sham) Week 12 data, controlling for Baseline data.
Time frame
Baseline, 3 months post DBS stimulation, 3 months post sham stimulationSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Virginia
Lead sponsor
Boston Scientific Corporation
Collaborator
Source ClinicalTrials.gov