Hippocampal Stimulation in Chronic Low Back Pain

Sponsor

Northwestern University (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04888494

Collaborator

National Institutes of Health (NIH) (NIH), National Institute on Drug Abuse (NIDA) (NIH)

Enrollment

Location

Arms

15.2

Anticipated Duration (Months)

1.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Pain Back Pain Pain	Device: Transcranial Magnetic Stimulation Device: Sham rTMS	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

16 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention 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.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:

Triple (Participant, Care Provider, Outcomes Assessor)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Jun 25, 2021

Actual Primary Completion Date :

Jun 1, 2022

Anticipated Study Completion Date :

Oct 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Hippocampus-stimulation Active high-frequency rTMS (20 Hz pulse trains)	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
Experimental: Sham-stimulation Sham rTMS	Device: Sham rTMS Sham rTMS

Arm

Intervention/Treatment

Experimental: Hippocampus-stimulation

Active high-frequency rTMS (20 Hz pulse trains)

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

Experimental: Sham-stimulation

Sham rTMS

Device: Sham rTMS

Sham rTMS

Outcome Measures

Primary Outcome Measures

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).

Secondary Outcome Measures

Changes in pain scales [1, 2 , 4 and 6 weeks]
The end point will be severity of pain measured by changes in chronic back pain as indexed by a Numeric rating Scale (NRS) before and after each stimulation round.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Northwestern University Feinberg School of Medicine	Chicago	Illinois	United States	60611

Sponsors and Collaborators

Northwestern University
National Institutes of Health (NIH)
National Institute on Drug Abuse (NIDA)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Apkar Apkarian, Director Center for Translational Pain Research, Director Center of Excellence for Chronic Pain and Drug Abuse Research, Professor of Physiology, Anesthesia, PM&R Northwestern University, Feinberg School of Medicine, Northwestern University

ClinicalTrials.gov Identifier:

NCT04888494

Other Study ID Numbers:

STU00211858
5P50DA044121

First Posted:

May 17, 2021

Last Update Posted:

Jul 6, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Keywords provided by Apkar Apkarian, Director Center for Translational Pain Research, Director Center of Excellence for Chronic Pain and Drug Abuse Research, Professor of Physiology, Anesthesia, PM&R Northwestern University, Feinberg School of Medicine, Northwestern University

transcranial magnetic stimulation

resting state MRI

Additional relevant MeSH terms:

Back Pain

Low Back Pain

Chronic Pain

Study Results

No Results Posted as of Jul 6, 2022