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Insula Neuromodulation for Chronic Neuropathic Pain

NCT05404581 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2024-12-10

No results posted yet for this study

Summary

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

Conditions

Interventions

DEVICE

neuromodulation

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.

Sponsors & Collaborators

  • Boston Scientific Corporation

    collaborator INDUSTRY

  • University of Virginia

    lead OTHER

Principal Investigators

  • Jeff Elias, MD · University of Virginia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-01
Primary Completion
2026-06-30
Completion
2027-06-29
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05404581 on ClinicalTrials.gov