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Hippocampal Stimulation in Chronic Low Back Pain

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Northwestern University

Status

Completed

Conditions

Back Pain
Chronic Pain
Pain

Treatments

Device: Sham rTMS
Device: Transcranial Magnetic Stimulation

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT04888494
5P50DA044121 (U.S. NIH Grant/Contract)
STU00211858

Details and patient eligibility

About

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.

Enrollment

16 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Triple Blind

16 participants in 2 patient groups

Hippocampus-stimulation
Experimental group
Description:
Active high-frequency rTMS (20 Hz pulse trains)
Treatment:
Device: Transcranial Magnetic Stimulation
Sham-stimulation
Experimental group
Description:
Sham rTMS
Treatment:
Device: Sham rTMS

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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