DBS of the SCC for the Treatment of Medically Refractory CLBP

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial Description

Chronic low back pain (CLBP) is one of the most ubiquitous and intractable problems in medicine and a significant source of patient suffering and disability, leading to opioid misuse and addiction. Previous neuromodulatory therapies for CLBP have focused primarily on spinal etiologies and intra-spinal mechanisms of pain transmission. However, existing pharmacological and neuromodulatory therapies have not been successful in treating CLBP. This project aims to address critical gaps and the unmet therapeutic needs of CLBP patients by using the Abbott Infinity DBS System; a next generation DBS device with directional steering capability implanted bilaterally in the subgenual cingulate cortex (SCC) to engage networks known to mediate the affective component of CLBP. The objective is to (1) Assess the preliminary efficacy of DBS of the SCC in the treatment of medically refractory CLBP; (2) Demonstrate the safety and feasibility of SCC DBS for CLBP; and (3) Develop diffusion tensor imaging (DTI)-based blueprints of response to SCC DBS for CLBP. The overall impact of this proof-of-concept pilot trial includes validation of the concept that suffering from CLBP results from pathological activity in affective brain networks, that these networks can be accurately engaged using a next-generation directional DBS device in a safe and feasible manner, and the discover of neuroimaging biomarkers of response to SCC DBS for CLBP. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04085406
Study type	Interventional
Source	University of California, Los Angeles
Contact	Wenxin Wei
Phone	3108170451
Email	WenxinWei@mednet.ucla.edu
Status	Recruiting
Phase	N/A
Start date	May 1, 2021
Completion date	June 30, 2024

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05963451` - Brain, Psychological and Epigenetic Determinants for Optimizing the Treatment of Chronic Low Back Pain
Completed	`NCT04283370` - A Study Protocol Comparing a Home Rehabilitation Program Versus e-Health Program in Low Back Pain	N/A
Completed	`NCT04824547` - Evaluation of Long-Term Continuity of Exercises in Low Back Pain Individuals	N/A
Completed	`NCT04046419` - In Turkish Version "Health Care Providers and Impairment Relationship Scale (HC-PAIRS)"
Completed	`NCT04399772` - COgNitive FuncTional Therapy+ for Chronic Low Back paIn	N/A
Recruiting	`NCT05780021` - Motivational Support Program in Chronic Low Back Pain After Multidisciplinary Functional Rehabilitation	N/A
Completed	`NCT04555278` - Combining Non-invasive Brain Stimulation and Exercise to Treat Low Back Pain	N/A
Completed	`NCT04530071` - Evaluation of Safety, Tolerability, and Efficacy of CordSTEM-DD in Patients With Chronic Low Back Pain	Phase 1/Phase 2
Not yet recruiting	`NCT06080464` - Clinician Satisfaction With the VERABAND™	N/A
Not yet recruiting	`NCT06347328` - The Benefits of Posterior Joint Infiltration in Chronic Low Back Pain	N/A
Not yet recruiting	`NCT04940715` - Efficacy of Passive Joint Mobilization vs Mobilization With Movement on Pain Processing in Patients With Chronic Low Back Pain	N/A
Recruiting	`NCT04683718` - A First in Human Feasibility Study to Evaluate the Safety and Effectiveness of the BIOTRONIK Prospera SCS System With HomeStream Remote Management	N/A
Recruiting	`NCT05724160` - Using Non-Weightbearing Stationary Elliptical Machines for Patients With Chronic Low Back Pain	N/A
Recruiting	`NCT06030128` - Core Stabilization Exercise Therapy in Chronic Lower Back Back Management in Community Dwelling Older Adults	N/A
Recruiting	`NCT05846087` - Mobile App-delivered Sleep Therapy (SleepFix) for Individuals With Chronic Low Back Pain and Insomnia	N/A
Active, not recruiting	`NCT05396014` - The BEST Trial: Biomarkers for Evaluating Spine Treatments	Phase 4
Active, not recruiting	`NCT06140862` - Ankle Spine Syndrome "RAFFET Syndrome II	N/A
Completed	`NCT05512338` - Motivation and Adherence to Exercise Recommendations	N/A
Recruiting	`NCT05021146` - Essential Oil for Chronic Low Back Pain	N/A
Completed	`NCT05120921` - Osteopathic Single CAse Research for Patients With Chronic Low Back Pain	N/A