rTMS for Relieving Chronic OA Pain

Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05097729
• Other study ID #: STU00214446
• Status: Withdrawn
• Phase: N/A
• Start date: November 15, 2021
• Est. completion date: January 1, 2023

Study information

• Verified date: February 2023
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 1, 2023
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Pain
• Osteo Arthritis Knee
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

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

Locations

Country	Name	City	State
United States	Northwestern University	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Pain trajectories	Individual pain trajectories will be analyzed to assess rTMS effects with greater temporal granularity.	1 to 12 weeks (end of the study)
Secondary	Brain biomarkers and psychological indicators of rTMS effects and pain relief	Test for objective mechanistic brain correlates (using functional magnetic resonance imaging - fMRI) for treatment efficacy. Specific regions of interest (ROI) involved in the hippocampal network will be studied.	1 to 12 weeks (end of the study)
Secondary	Adverse events	Incidence of adverse events will be reported for after each rTMS session.The frequency and severity of adverse effects will be compared between each rTMS modality.	1 to 12 weeks (end of the study)
Secondary	Global impression of change	Global impression of change (PGIC): this questionnaire reflects a patient's belief about the efficacy of treatment. Although widely used in chronic pain clinical trials, PGIC's validity has not been formally assessed. PGIC is a 7 point scale depicting a patient's rating of overall improvement.	1 to 12 weeks - after each rTMS round.