Insula Neuromodulation for Chronic Neuropathic Pain

Part of paid clinical trials in Charlottesville, Virginia.

Sponsor
University of Virginia
Study ID
NCT05404581
Status
Recruiting
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Conditions

  • Chronic Pain
  • Neuropathic Pain

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • neuromodulation — DEVICE
    During 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.

Study Details

This study will comprehensively investigate the insula as a brain target for neuromodulation to treat chronic neuropathic pain.

Key Dates

Start date
Nov 1, 2022
Status verified
May 2024
Primary completion
Jun 30, 2026
Completion
Jun 29, 2027

Study Design

Enrollment
12 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Sham Comparator: Control
    Subjects who respond favorably to test/trial stimulation of the insula will be implanted with DBS devices. In an outpatient clinical trial, each subject will receive 3 months of active stimulation and 3 months of sham stimulation. The assignment for stimulation will be randomized and blinded to the subject and to the outcome assessors.
  • Active Comparator: DBS of the insula
    Subjects who respond favorably to test/trial stimulation of the insula will be implanted with DBS devices. In an outpatient clinical trial, each subject will receive 3 months of active stimulation and 3 months of sham stimulation. The assignment for stimulation will be randomized and blinded to the subject and to the outcome assessors.

Primary Outcome Measure

Adverse events [ Time Frame: Entire study period from enrollment through 6 months post DBS implantation ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of VirginiaCharlottesvilleVirginia22903
Zak Sturgill
[email protected]
434-243-9986
Jeff Elias, MD (PRINCIPAL_INVESTIGATOR)

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University of Virginia· Charlottesville, VA

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