NCT05097729

rTMS for Relieving Chronic OA Pain

Transcranial Magnetic Stimulation to Enhance Cortical Hippocampal Functional Connectivity as a Novel Means for Relieving Chronic OA Pain

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Northwestern University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	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

Timeline

• Start date: 2021-11-15
• Primary completion: 2022-12-01
• Completion: 2023-01-01
• First posted: 2021-10-28
• Last updated: 2023-02-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study