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Neurostimulation

Deep Brain Stimulation for Chronic Lower Back Pain

N/A

Recruiting

Led By Ausaf Bari, MD PhD

Research Sponsored by University of California, Los Angeles

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Pain secondary to failed back surgery syndrome (FBSS) as defined by persistent low back pain despite prior surgical interventions

Self-reported average back pain intensity of greater than 8 out of 10 on the Visual Analog Scale (VAS) documented over greater than 2 years

Must not have

Age > 75 years

History of bleeding disorder or immune-compromise

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 18 months - the end of the study

Summary

This trial will test whether deep brain stimulation of the subgenual cingulate cortex can help people with chronic low back pain that hasn't responded to other treatments.

Who is the study for?

This trial is for adults over 40 with severe chronic lower back pain that hasn't improved after surgery, physical therapy, spinal procedures, opioid or other pain medication trials. Candidates must have tried and not responded to spinal cord stimulation, be able to consent and follow up for 1.5 years, and live within 100 miles of UCLA. Exclusions include cognitive impairment, bleeding disorders, substance abuse issues in the last six months, uncontrolled medical conditions like heart disease or diabetes, pregnancy or planning to become pregnant.

What is being tested?

The study tests deep brain stimulation (DBS) of the subgenual cingulate cortex as a treatment for chronic low back pain that doesn't respond to conventional therapies. It uses a randomized double-blind crossover design where neither participants nor researchers know who receives the real treatment until after the results are collected.

What are the potential side effects?

Potential side effects may include neurological changes or psychiatric symptoms due to DBS; these should be reported immediately. There's also a risk associated with any surgical procedure such as infection or bleeding.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I still have lower back pain despite having back surgery.

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I have had severe back pain averaging over 8/10 for more than 2 years.

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Physical therapy for 4 weeks did not cut my pain by half.

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My back pain didn't improve by half after 2 spinal procedures.

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My pain hasn't improved by half after 3 months of opioid treatment, or I can't handle the side effects.

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My pain hasn't improved by half despite trying non-opioid meds for 3 months, or I can't handle the side effects.

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Two neurosurgeons agree surgery can't fix my pain.

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I am over 40 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am over 75 years old.

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I have a history of bleeding disorders or a weakened immune system.

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I had spine surgery in the last 3 months.

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I have serious health issues that could make surgery risky.

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I do not have any uncontrolled health issues like heart problems or diabetes.

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I am taking blood thinners.

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I have had brain surgery in the past.

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I cannot stop my current diathermy treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 18 months - the end of the study

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~18 months - the end of the study

This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 months - the end of the study for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

At least 10% of study participants to experience one or more significant adverse events (SAEs)

Anxiety

Pain

Secondary study objectives

50% improvement in McGill Pain Questionnaire (MPQ)

Change in EuroQol 5-Domain (EQ-5D) Score

Change in Montreal Cognitive Assessment Score (MoCA)

+14 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Active StimulationExperimental Treatment1 Intervention

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).

Group II: Sham StimulationPlacebo Group1 Intervention

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).

0 / 16Eligibility criteria met