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Deep Brain Stimulation of the Subgenus Cingulate Cortex for Chronic Lower Back Pain

University of Texas Southwestern Medical Center, Dallas, TX
Chronic Lower Back PainDeep Brain Stimulation of the Subgenus Cingulate Cortex - Device
Eligibility
40 - 75
All Sexes

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.

Eligible Conditions
  • Chronic Lower Back Pain

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
N/A

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Study Objectives

3 Primary · 17 Secondary · Reporting Duration: 18 months - the end of the study

Month 12
50% improvement in McGill Pain Questionnaire (MPQ)
Change in EuroQol 5-Domain (EQ-5D) Score
Change in Montreal Cognitive Assessment Score (MoCA)
Change in Short-Form 36 (SF-36) quality of life questionnaire score.
Anxiety
Change in dose and/or frequency of opioid analgesic medication use in oral morphine equivalents.
Change in the Hamilton Depression Rating Scale (HAM-D)
Change in the NIH Pain Intensity Survey
Change in the NIH Toolbox General Life Satisfaction CAT
Change in the NIH Toolbox Locomotion
Pain
Change in the NIH Toolbox Perceived Stress Fixed Form (FF)
Body Weight Changes
Change in the NIH Toolbox Sadness CAT
Change in the Oswestry Disability Index (ODI)
Change in the PROMIS Pain Behavior CAT
Change in the PROMIS Pain Intensity Scale 3a
Cat Diseases
Pain
Month 18
At least 10% of study participants to experience one or more significant adverse events (SAEs)

Trial Safety

Phase-Based Safety

1 of 3

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Trial Design

2 Treatment Groups

Active Stimulation
1 of 2
Sham Stimulation
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Experimental Treatment

Non-Treatment Group

16 Total Participants · 2 Treatment Groups

Primary Treatment: Deep Brain Stimulation of the Subgenus Cingulate Cortex · Has Placebo Group · N/A

Active Stimulation
Device
Experimental Group · 1 Intervention: Deep Brain Stimulation of the Subgenus Cingulate Cortex · Intervention Types: Device
Sham Stimulation
Device
ShamComparator Group · 1 Intervention: Deep Brain Stimulation of the Subgenus Cingulate Cortex · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 18 months - the end of the study

Who is running the clinical trial?

University of California, Los AngelesLead Sponsor
1,442 Previous Clinical Trials
10,081,665 Total Patients Enrolled
Ausaf Bari, MD PhDPrincipal InvestigatorUCLA Department of Neurosurgery

Eligibility Criteria

Age 40 - 75 · All Participants · 5 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are willing to tell the study doctors if you experience any unexpected mental or nerve-related symptoms.
You have tried physical therapy for at least 4 weeks, but it did not reduce your pain by at least 50%.
You have tried other pain medications for at least 3 months and they did not provide enough relief or you cannot tolerate higher doses of non-opioid pain medications due to side effects.
You still have low back pain even after having surgery for it before.
You have experienced severe back pain, with an average pain level of 8 or higher on a scale of 1 to 10, for more than 2 years.
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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