rTMS for Relieving Chronic OA Pain

NCT ID: NCT05097729

Last Updated: 2023-02-03

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-15
• Study Completion Date: 2023-01-01

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.

Detailed Description

Osteoarthritis (OA) pain is one of the most prevalent causes of chronic pain worldwide. Symptoms can last from months to a lifetime, severely impacting patients' quality of life. New strategies - including non-invasive brain stimulation techniques - have shown promise for sustained pain relief, yet evidence on their reliability and efficacy is limited. Apkarian et. al have previously shown that the dorsal hippocampus plays a central role in pain analgesia; thus, the study aim is to test whether non-invasively enhancing dorsal hippocampus activity is a useful new strategy for pain relief in knee OA patients. This study will recruit 35 patients with chronic OA pain for > 6 months. Each participant will receive 3 rounds of different treatment modalities in a cross-over manner. Each treatment modality will consist of 5 daily consecutive rTMS sessions followed by a 2-weeks wash-out period. Questionnaires will be completed prior to and following each intervention, and after each treatment round. Participants will be trained to use a pain electronic application (smartphone-based tool to rate pain intensity and mood on NRS scales, as well as indicate rescue medication use, developed in our lab). They will be asked to use this application for 7-10 days prior to the first round of intervention and during the study duration.

Conditions

Chronic Pain; Osteo Arthritis Knee

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Stimulation Modality 1

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.

Group Type: EXPERIMENTAL

Transcranial Magnetic Stimulation

Intervention Type: 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

Stimulation Modality 2

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

Group Type: SHAM_COMPARATOR

Transcranial Magnetic Stimulation

Intervention Type: 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

Stimulation Modality 3

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.

Group Type: ACTIVE_COMPARATOR

Transcranial Magnetic Stimulation

Intervention Type: 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

Interventions

Transcranial Magnetic Stimulation

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

Intervention Type: DEVICE

Other Intervention Names

TMS

Eligibility Criteria

Inclusion Criteria

• ≥ 6 months of knee pain on a daily basis;
• male or female with no racial or ethnic restrictions;
• 18 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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Apkar Apkarian

Director Center for Translational Pain Research, Director Center of Excellence for Chronic Pain and Drug Abuse Research, Professor of Neuroscience, Anesthesia, PM&R

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Northwestern University

Chicago, Illinois, United States

Countries

United States

Other Identifiers

STU00214446

Identifier Type: -

Identifier Source: org_study_id