Hippocampal Stimulation in Chronic Low Back Pain

NCT04888494 | Completed Results FDA Device

• 2 other identifiers: STU002118585P50DA044121
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain; Back Pain; Pain

Keywords

transcranial magnetic stimulation; resting state MRI

Outcome Measures

Primary Outcomes (1)

• 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.

  Pain is assessed at baseline, end of first intervention and end of the second intervention.

Secondary Outcomes (1)

• Changes in Hippocampal Connectivity

  approximately 6 weeks - Baseline and after the end of hippocampal stimulation

Study Arms (2)

Hippocampus-stimulation

EXPERIMENTAL

Active high-frequency rTMS (20 Hz pulse trains)

Device: Transcranial Magnetic Stimulation

Sham-stimulation

EXPERIMENTAL

Sham rTMS

Device: Sham rTMS

Interventions

Transcranial Magnetic Stimulation 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

Hippocampus-stimulation

Sham rTMS DEVICE

Sham rTMS

Sham-stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 6 months of back pain on a daily basis;
• male or female with no racial or ethnic restrictions;
• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Northwestern University: lead
• National Institutes of Health (NIH): collaborator
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Northwestern University Feinberg School of Medicine

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Chronic Pain; Back Pain; Pain

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Results Point of Contact

• Title: A. Vania Apkarian
• Organization: Northwestern University

a-apkarian@northwestern.edu

+1 312 503 0404

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: 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

Model Details: 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.

Study Record Dates

• First Submitted: May 12, 2021
• First Posted: May 17, 2021
• Study Start: June 25, 2021
• Primary Completion: June 1, 2022
• Study Completion: February 2, 2023
• Last Updated: June 15, 2023
• Results First Posted: June 15, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF

Locations

US (1)