DBS of the SCC for the Treatment of Medically Refractory CLBP

Part of paid clinical trials in Los Angeles, California.

Sponsor
University of California, Los Angeles
Study ID
NCT04085406
Status
Recruiting
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Conditions

  • Chronic Low-back Pain

Eligibility Criteria

Sex
ALL
Age
40 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Deep Brain Stimulation of the Subgenus Cingulate Cortex — DEVICE
    The Abbott Infinity DBS device will be surgically implanted in the bilateral subgenual cingulate cortex to provide electrical stimulation to this region.

Study Details

The purpose of this study is to evaluate the feasibility and preliminary efficacy of deep brain stimulation of the subgenual cingulate cortex for the treatment of chronic medically-refractory low back pain using a randomized double-blind crossover design.

Key Dates

Start date
May 1, 2021
Status verified
Jul 2025
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

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

Arms

  • Experimental: Active Stimulation
    Patients will be randomized in a 1:1 ratio to one of two groups: Active Treatment (active stimulation programmed to the settings found to be optimal during the initial open-label period) and a Control Group (sham stimulation - IPG is set to ON but the voltage is set to 0V).
  • Sham Comparator: Sham Stimulation
    Patients will be randomized in a 1:1 ratio to one of two groups: Active Treatment (active stimulation programmed to the settings found to be optimal during the initial open-label phase) and a Control Group (sham stimulation - IPG is set to ON but the voltage is set to 0V).

Primary Outcome Measure

Change of at least 50% in pain scores on the visual analog scale (VAS) compared to baseline. [ Time Frame: 12 months - the end of the crossover period ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of California Los AngelesLos AngelesCalifornia90067
Ausaf Bari
[email protected]
310-825-4321
University of Texas Southwestern Medical CenterDallasTexas75390
Nader Pouratian, MD PhD
[email protected]

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By research site
University of California Los Angeles· Los Angeles, CAUniversity of Texas Southwestern Medical Center· Dallas, TX

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