Hippocampal Stimulation in Chronic Low Back Pain

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-25

Study Completion Date

2023-02-02

Brief Summary

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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.

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Detailed Description

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Conditions

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Chronic Pain Back Pain Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Hippocampus-stimulation

Active high-frequency rTMS (20 Hz pulse trains)

Group Type EXPERIMENTAL

Transcranial Magnetic Stimulation

Intervention Type DEVICE

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

Sham-stimulation

Sham rTMS

Group Type EXPERIMENTAL

Sham rTMS

Intervention Type DEVICE

Sham rTMS

Interventions

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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

Intervention Type DEVICE

Sham rTMS

Intervention Type DEVICE

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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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

Responsibility Role PRINCIPAL_INVESTIGATOR