Hippocampal Stimulation in Chronic Low Back Pain

Enhancing Cortical-hippocampal Functional Connectivity as a Novel Means for Relieving 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.

Study Overview

• Status: Completed
• Conditions: Pain; Back Pain; Chronic Pain
• Intervention / Treatment: Device: Sham rTMS; Device: Transcranial Magnetic Stimulation

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University Feinberg School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hippocampus-stimulation; Active high-frequency rTMS (20 Hz pulse trains)	Device: Transcranial Magnetic Stimulation; 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
Experimental: Sham-stimulation; Sham rTMS	Device: Sham rTMS; Sham rTMS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Pain Scales	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.	Pain is assessed at baseline, end of first intervention and end of the second intervention.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Hippocampal Connectivity	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).	approximately 6 weeks - Baseline and after the end of hippocampal stimulation

Collaborators and Investigators

• Sponsor: Northwestern University
• Collaborators: National Institute on Drug Abuse (NIDA); National Institutes of Health (NIH)

Study record dates

Study Major Dates

• Study Start (Actual): June 25, 2021
• Primary Completion (Actual): June 1, 2022
• Study Completion (Actual): February 2, 2023

Study Registration Dates

• First Submitted: May 12, 2021
• First Submitted That Met QC Criteria: May 14, 2021
• First Posted (Actual): May 17, 2021

Study Record Updates

• Last Update Posted (Actual): June 15, 2023
• Last Update Submitted That Met QC Criteria: May 23, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: transcranial magnetic stimulation; resting state MRI
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain; Chronic Pain
• Other Study ID Numbers: STU00211858; 5P50DA044121 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Documents will be provided by Apkar Apkarian
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No