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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18 months - the end of the study
Awards & highlights
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.Check my eligibility
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.See study design
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 belowSelect...
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.
Select...
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.
Select...
My pain hasn't improved by half despite trying non-opioid meds for 3 months, or I can't handle the side effects.
Select...
Two neurosurgeons agree surgery can't fix my pain.
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I am over 40 years old.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
At least 10% of study participants to experience one or more significant adverse events (SAEs)
Anxiety
Pain
Secondary outcome measures
50% improvement in McGill Pain Questionnaire (MPQ)
Change in EuroQol 5-Domain (EQ-5D) Score
Change in Montreal Cognitive Assessment Score (MoCA)
+14 moreTrial 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).
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Who is running the clinical trial?
University of California, Los AngelesLead Sponsor
1,529 Previous Clinical Trials
10,277,786 Total Patients Enrolled
Ausaf Bari, MD PhDPrincipal InvestigatorUCLA Department of Neurosurgery
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You cannot have MRIs or need to have MRIs often.I still have lower back pain despite having back surgery.I have had severe back pain averaging over 8/10 for more than 2 years.I did not get enough pain relief from spinal cord stimulation or I refused it.Physical therapy for 4 weeks did not cut my pain by half.You have had an infection related to a previous medical implant.My back pain didn't improve by half after 2 spinal procedures.You have tried to harm yourself in the past two years or have a plan to harm yourself.You have had a problem with alcohol or illegal drugs in the past 6 months, or your drug or alcohol use could affect how the treatment works for you.I have a history of bleeding disorders or a weakened immune system.I had spine surgery in the last 3 months.My pain hasn't improved by half despite trying non-opioid meds for 3 months, or I can't handle the side effects.My pain hasn't improved by half after 3 months of opioid treatment, or I can't handle the side effects.I do not have any major neurological conditions that DBS could worsen.I have serious health issues that could make surgery risky.I am over 40 years old.I do not have any uncontrolled health issues like heart problems or diabetes.I cannot stop my current diathermy treatment.You have a significant problem with memory and thinking, as measured by a test called the MoCA, and your score is less than 26.I am over 75 years old.I am taking blood thinners.You have a major abnormality on your brain MRI before surgery.You have a pending or approved worker's compensation claim.You currently have a spinal cord stimulation device implanted.You have a mental health condition other than depression or generalized anxiety disorder, as determined by a specific interview.You have medical devices like pacemakers, implanted pumps, or certain implants in your body.I have had brain surgery in the past.You are expected to live less than 1 year for any reason.You are currently involved in a legal claim related to an injury.Two neurosurgeons agree surgery can't fix my pain.
Research Study Groups:
This trial has the following groups:- Group 1: Active Stimulation
- Group 2: Sham Stimulation
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this research program have an age restriction, and if so what is it?
"This trial's enrolment rules dictate that the minimum age for applicants is fifty, while the cap on participation is set at seventy-five."
Answered by AI
Are there any slots available for patients to join this clinical investigation?
"Reportedly, this clinical investigation is presently recruiting patients. This trial was initially posted on May 1st 2021 and the most recent revision occurred on May 27th 2022."
Answered by AI
Do I meet the criteria for participating in this medical experiment?
"Candidates with low back pain aged between 50 and 75 years old are invited to apply for the trial, which is limited to a cohort of 16 participants."
Answered by AI
What is the aim of this medical experiment?
"This 12-month clinical trial will measure the efficacy of a given intervention by assessing changes in pain scores from baseline as measured on the Pain Anxiety Symptoms Scale -- Short Form 20 (PASS SF-20). The quality of life, interference with daily activities and intensity of pain experienced are also to be tracked via responses to questionnaires such as the NIH Toolbox Pain Interference Computer Adaptive Test (CAT) and PROMIS Pain Intensity Scale 3a. A score change of at least 50% is desired when compared against baseline data."
Answered by AI
How many individuals are actively participating in this investigation?
"Affirmative, clinicaltrials.gov's archives give evidence that this trial is accepting participants at present. The original posting of the study dates back to May 1st 2021 and was last refreshed on May 27th 2022. Recruitment aims for a total of 16 patients from one medical centre."
Answered by AI
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