Status:
COMPLETED
Hippocampal Stimulation in Chronic Low Back Pain
Lead Sponsor:
Northwestern University
Collaborating Sponsors:
National Institutes of Health (NIH)
National Institute on Drug Abuse (NIDA)
Conditions:
Chronic Pain
Back Pain
Eligibility:
All Genders
18+ years
Phase:
NA
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.
Eligibility Criteria
Inclusion
- ≥ 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
- 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)
Key Trial Info
Start Date :
June 25 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 2 2023
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT04888494
Start Date
June 25 2021
End Date
February 2 2023
Last Update
June 15 2023
Active Locations (1)
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1
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States, 60611