Hippocampal Stimulation in Chronic Low Back Pain

Not Applicable

Completed

Brief 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 & Eligibility

Inclusion Criteria

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)

Arm && Interventions

Group	Intervention	Description
Hippocampus-stimulation	Transcranial Magnetic Stimulation	Active high-frequency rTMS (20 Hz pulse trains)
Sham-stimulation	Sham rTMS	Sham rTMS

Primary Outcome Measures

Name	Time	Method
Changes in Pain Scales	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 Outcome Measures

Name	Time	Method
Changes in Hippocampal Connectivity	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).