Hippocampal Stimulation in Chronic Low Back Pain

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04888494
• Other study ID #: STU00211858
• Secondary ID: 5P50DA044121
• Status: Completed
• Phase: N/A
• Start date: June 25, 2021
• Est. completion date: February 2, 2023

Study information

• Verified date: May 2023
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: February 2, 2023
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Back Pain
• Chronic Pain
• Low Back Pain
• Pain

Intervention

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
• Sham rTMS
Sham rTMS

Locations

Country	Name	City	State
United States	Northwestern University Feinberg School of Medicine	Chicago	Illinois

Sponsors (3)

Lead Sponsor	Collaborator
Northwestern University	National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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