Recruiting

Brain Imaging Biomarkers

Sponsor:

UCLA

Code:

NCT04658628

Conditions

Chronic Low-back Pain

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

In this protocol, "Brain imaging biomarkers for response to Spinal Cord Stimulation in patients with chronic low back pain," the investigators plan to perform brain mapping studies in 42 patients who are undergoing spinal cord stimulation (SCS) for chronic low back pain (CLBP) as part of the participants normal clinical care during a 2-year period. This imagining study is completed for research purposes. There is no standard of care imaging for the participants. This study requires two visits in total. During the baseline visit, participants will undergo imaging acquisition protocol and corresponding assessments. Participants will have another follow-up visit (potentially remotely) for final assessments two weeks after the SCS treatment. The objective of the study is to investigate potential imaging biomarkers that can predict response to the SCS treatment. Specifically, the investigators hypothesize that the connectivity of a certain region of the brain (specifically the subgenual cingulate) prior to SCS may serve as a possible pre-operative imaging-based biomarker on response to SCS. The findings of the study may further enhance investigators understanding of the connectivity between brain areas that are critical to the therapeutic response to SCS in CLBP patients and that can be used as a putative biomarker to select patients who may respond to SCS.

Conditions

Chronic Low-back Pain

Study ID

NCT04658628

Start date

Jan 22, 2021

Status verified date

Sep, 2025

Completion date

Nov, 2027

Anticipated

Primary completion date

Nov, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Male or female ≥ 21 years of age at time of consent
  • Subject has been recommended to undergo an SCS trial for chronic back with or without leg pain by their pain management physician
  • Chronic low back pain as defined by persistent low back pain despite prior treatments that continues for 12 weeks or longer
  • Subject signs a valid, Institutional Review Board (IRB)-approved informed consent form (ICF) provided

Exclusion Criteria:

  • Subject is a woman who is not using adequate contraception, is pregnant or breastfeeding or intends to become pregnant during the course of the study
  • Subject has previously undergone a spinal cord stimulation trial or is already implanted with an active implantable device(s) to treat their pain (Implantable Pulse Generators (IPGs), implantable drug pump, etc.) or pacemaker or implantable cardiac defibrillator
  • Subject is currently abusing alcohol or illicit drugs
  • Contraindications to MRIs or the need for recurrent body MRIs
  • Presence of cardiac pacemakers/defibrillators, implanted medication pumps, intra-cardiac lines, any intracranial implants (e.g., aneurysm clip, shunt, cochlear implant, electrodes) or other implanted stimulators

Study Design

Enrollment

42 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Change in VAS [ Time Frame: Baseline and 2 weeks ]
  • Change in HAMD-17 [ Time Frame: Baseline and 2 weeks ]
  • Change in MPQ [ Time Frame: Baseline and 2 weeks ]
  • Change in PASS [ Time Frame: Baseline and 2 weeks ]

Central Contacts and Locations

Central contacts

Meskereen Tolossa

310-206-9187MTolossa@mednet.ucla.edu

Locations

University of California Los Angeles

Recruiting

Los Angeles, California, United States, 90067

Contacts

Evangelia Tsolaki

3108254321Etsolaki@mednet.ucla.edu

More Information

Sponsor

University of California, Los Angeles

Last update posted

Oct 2, 2025

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of California, Los Angeles on 2025-10-02.