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Hippocampal Stimulation in Chronic Low Back Pain

Primary Purpose

Chronic Pain, Back Pain, Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transcranial Magnetic Stimulation
Sham rTMS
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Chronic Pain focused on measuring transcranial magnetic stimulation, resting state MRI

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • Northwestern University Feinberg School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Hippocampus-stimulation

Sham-stimulation

Arm Description

Active high-frequency rTMS (20 Hz pulse trains)

Sham rTMS

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).

Full Information

First Posted
May 12, 2021
Last Updated
May 23, 2023
Sponsor
Northwestern University
Collaborators
National Institutes of Health (NIH), National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT04888494
Brief Title
Hippocampal Stimulation in Chronic Low Back Pain
Official Title
Enhancing Cortical-hippocampal Functional Connectivity as a Novel Means for Relieving Chronic Low Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
June 25, 2021 (Actual)
Primary Completion Date
June 1, 2022 (Actual)
Study Completion Date
February 2, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University
Collaborators
National Institutes of Health (NIH), National Institute on Drug Abuse (NIDA)

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain, Back Pain, Pain
Keywords
transcranial magnetic stimulation, resting state MRI

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
All participants will receive the 2 modalities of stimulation (hippocampal and sham-TMS). Each stimulation round is composed by 5 daily sessions of stimulation, participants will not know which round is active and which is sham. The order of the stimulation modalities will be different across subjects. Subjects will be randomly assigned to one of two possible modality order according to the entrance in the study.
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hippocampus-stimulation
Arm Type
Experimental
Arm Description
Active high-frequency rTMS (20 Hz pulse trains)
Arm Title
Sham-stimulation
Arm Type
Experimental
Arm Description
Sham rTMS
Intervention Type
Device
Intervention Name(s)
Transcranial Magnetic Stimulation
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
Sham rTMS
Intervention Description
Sham rTMS
Primary Outcome Measure Information:
Title
Changes in Pain Scales
Description
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.
Time Frame
Pain is assessed at baseline, end of first intervention and end of the second intervention.
Secondary Outcome Measure Information:
Title
Changes in Hippocampal Connectivity
Description
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).
Time Frame
approximately 6 weeks - Baseline and after the end of hippocampal stimulation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
Northwestern University Feinberg School of Medicine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Documents will be provided by Apkar Apkarian

Learn more about this trial

Hippocampal Stimulation in Chronic Low Back Pain

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