rTMS for Relieving Chronic OA Pain

NCT05097729 | Withdrawn FDA Device

• 1 other identifier: STU00214446
• Study Type: interventional
• Target: N/A
• 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 pain due to knee osteoarthritis.

Conditions

Chronic Pain; Osteo Arthritis Knee

Outcome Measures

Primary Outcomes (1)

• Pain ratings (Numeric Rating Scale)

  The primary efficacy outcomes are the effects of the rTMS modalities on pain app ratings.

  Pain ratings immediately after each rTMS modality and effects after the end of stimulation round (1 week).

Secondary Outcomes (4)

• Pain trajectories

  1 to 12 weeks (end of the study)

• Brain biomarkers and psychological indicators of rTMS effects and pain relief

  1 to 12 weeks (end of the study)

• Adverse events

  1 to 12 weeks (end of the study)

• Global impression of change

  1 to 12 weeks - after each rTMS round.

Study Arms (3)

Stimulation Modality 1

EXPERIMENTAL

Repetitive TMS will be applied at 100% resting motor threshold intensity to a region of interest located in the parietal cortex, that will be determined based on its connectivity with the hippocampus.

Device: Transcranial Magnetic Stimulation

Stimulation Modality 2

SHAM COMPARATOR

Parameters will be identical to the modality 1, except that the coil will be flipped over.

Device: Transcranial Magnetic Stimulation

Stimulation Modality 3

ACTIVE COMPARATOR

The stimulation will be delivered over the motor cortex contralateral to the predominant painful region, i.e., right motor cortex stimulation if left knee pain. The stimulation intensity will be set at 80% of the resting motor threshold.

Device: Transcranial Magnetic Stimulation

Interventions

Transcranial Magnetic Stimulation DEVICE

The brain stimulation can be delivery using different devices; in this project a MagPro X100 stimulator connected to a MagPro Cool-B65 liquid-cooled butterfly coil (MagVenture A/S, Farum, Denmark) will be used. Resting motor threshold (M1-rTMS) will be determined during the visit 1 or visit 2 and used along all visits. The rTMS pulse sequences and intensities used are all within the published safety guidelines

Also known as: TMS

Stimulation Modality 1; Stimulation Modality 2; Stimulation Modality 3

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 6 months of knee pain on a daily basis;
• male or female with no racial or ethnic restrictions;
• to 75 years old;
• average knee pain intensity \> 4/10 at study entry;
• must be able to read, understand, and sign consent form;
• generally healthy.
• able to use the PainApp

You may not qualify if:

• rheumatoid arthritis, ankylosing spondylitis, acute vertebral fractures,
• Chronic neurologic conditions, e.g., Parkinson's
• 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.

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Chronic Pain

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• 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 Neuroscience, Anesthesia, PM&R

Model Details: All participants will receive all the 3 modalities of stimulation in a randomized order. Each round is composed by 5 daily sessions of stimulation. Participants will have a second MRI only after Modality one (hippocampal).

Study Record Dates

• First Submitted: October 18, 2021
• First Posted: October 28, 2021
• Study Start: November 15, 2021
• Primary Completion: December 1, 2022
• Study Completion: January 1, 2023
• Last Updated: February 3, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will share

Locations

US (1)