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Completed

NCT Number: NCT04888494

Hippocampal Stimulation in Chronic Low Back Pain

In this study the investigators aim to examine the effects of Transcranial Magnetic Stimulation (TMS) on hippocampal network connectivity and pain levels in individuals with chronic low back pain.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northwestern University Feinberg School of Medicine

Chicago, Illinois, 60611, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ≥ 6 months of back pain on a daily basis;
  • male or female with no racial or ethnic restrictions;
  • 18 to 75 years old;
  • average back pain intensity > 4/10 at study entry;
  • must be able to read, understand, and sign consent form;
  • generally healthy.

Exclusion criteria

  • back pain with fever, chills, rheumatoid arthritis, ankylosing spondylitis, acute vertebral fractures,
  • history of tumor in the back;
  • back surgery within the past 6 months;
  • Chronic neurologic conditions, e.g., Parkinson's
  • involvement in litigation regarding back pain;
  • other severe medical diseases;
  • pregnancy;
  • positive urinary screen for any recreational drugs,
  • opioids use;
  • use of anticoagulants (low dose ASA allowed);
  • history of gastric ulcer; renal insufficiency or congestive heart failure,
  • contraindication to MRI,
  • contraindication to TMS; including history of seizure/epilepsy*
  • Any medical condition that in the investigator's judgment may prevent the individual from completing the study or put the individual at undue risk;
  • In the judgment of the investigator, unable or unwilling to follow protocol and instructions;
  • Diagnosis of major depression;
  • Intra-axial implants (e.g. spinal cord stimulators or pumps)

Treatment and study plan

Transcranial Magnetic Stimulation

Device

For the brain stimulation the investigators will use Repetitive Transcranial Magnetic stimulation (rTMS). Different stimulation conditions (hippocampal or sham) will be delivered in each round of stimulation (5 days). Repetitive TMS will be applied at 100% resting motor threshold intensity, 20 Hz pulse trains separated by 28-s inter-train intervals (~20 minutes for the entire daily stimulation session). Stimulation parameters will be identical in both groups

sham rTMS

Device

Sham rTMS

Primary outcomes

  1. Changes in Pain Scales

    Time frame: Pain is assessed at baseline, end of first intervention and end of the second intervention.

    The endpoint will be the severity of pain measured by changes in the Numeric Rating Scale (NRS) scores before and after each stimulation round. The NRS is a pain screening tool that assesses pain severity during assessment using a 0-10 scale, where zero means "no pain" and ten means "the worst pain imaginable." Higher values indicate a worse outcome.

Secondary outcomes

  1. Changes in Hippocampal Connectivity

    Time frame: approximately 6 weeks - Baseline and after the end of hippocampal stimulation

    Changes in hippocampal network connectivity will be evaluated by using resting state functional magnetic resonance (fMRI) before and after hippocampal stimulation. Hippocampal connectivity measurements - regions involved in the network and the parietal target - will be compared before stimulation (baseline) to after stimulation (after active hippocampal stimulation).

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)
  • National Institutes of Health (NIH)

Registry information

Official study title

Enhancing Cortical-hippocampal Functional Connectivity as a Novel Means for Relieving Chronic Low Back Pain

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
May 17, 2021
Registry last updated
Jun 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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