rTMS + Tai Chi for Osteoarthritis
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it does require that you haven't changed your psychotropic or pain medications in the past four months. This means you should be stable on your current medications before joining the trial.
What data supports the effectiveness of the treatment Repetitive Transcranial Magnetic Stimulation (rTMS) for osteoarthritis?
Is rTMS safe for humans?
Repetitive Transcranial Magnetic Stimulation (rTMS) is generally considered safe, with guidelines established to minimize risks. While it can cause seizures in rare cases, other side effects like cognitive changes are possible but not well understood. Safety guidelines have been developed and updated to ensure safe use in both research and clinical settings.26789
How is the treatment rTMS + Tai Chi for osteoarthritis different from other treatments?
The treatment combines repetitive transcranial magnetic stimulation (rTMS), a non-invasive method that uses magnetic fields to stimulate nerve cells in the brain, with Tai Chi, a gentle form of exercise. This combination is unique because rTMS is typically used for neurological conditions and not commonly for osteoarthritis, potentially offering a novel approach to managing symptoms by improving balance and physical function.17101112
What is the purpose of this trial?
Osteoarthritis (OA) is a major public health problem, and involvement of the knee is especially disabling. Symptomatic knee OA has an incidence rate between 40 to 1,020 per 100,000 person years1 and is among the most common causes of disability worldwide. Knee arthritis pain and disability are highly comorbid wiht depression (30-50%). Currently available treatments offer only limited relief. The Pilot project aims to establish feasibility of the rTMS neuromodulation of response to Tai Chi and improvement in pain and comorbid depression in patients with knee OA. There are several ways in which the pilot project will improve scientific knowledge, and clinical practice: 1) The sequential stimulation of two targets (M1 and l-DLPFC) has not been systematically examined for the treatment of comorbid MDD and knee OA. We hypothesize that using a multi-target rTMS strategy combining M1 and l-DLPFC- active targets will be well tolerated and more effective to treat comorbid symptoms than single site rTMS to M1+l-DLPFCsham. This hypothesis will be tested in Aim 1 of this proposal by comparing two experimental conditions: A) M1active and l-DLPFCactive; and B) M1active and l-DLPFCsham. 2) Identifying the relationship between improvement in pain and depression to improvement in pro-inflammatory cytokines would be novel. Adding an rTMS as a neuromodulation technique with novel stimulation sites to assist in the reduction of symptoms of pain and depression is another scalable to clinical use opportunity that will provide pilot data for future clinical trials. We will perform a pilot feasibility trial of rTMS for those presenting with knee osteoarthritis related pain and moderate to severe depression in 30 volunteers who are undergoing Tai Chi intervention. Tolerability and safety of rTMS added to Tai Chi will be assessed along with changes in symptoms of pain and depression, in preparation to future R-01 applications.
Eligibility Criteria
This trial is for individuals over 50 with knee osteoarthritis and persistent depression, who can walk unaided and are willing to attend Tai Chi sessions. They must have chronic pain, a high depression score, internet access for telehealth, and no recent medication changes or serious health conditions that would limit participation.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive rTMS treatment combined with Tai Chi intervention for knee OA pain and depression
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Repetitive Transcranial Magnetic Stimulation
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of California, Los Angeles
Lead Sponsor