NCT06906939 A Randomized Pilot rTMS Trial for Knee Arthritis Pain and Depression
| NCT ID | NCT06906939 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | University of California, Los Angeles |
| Condition | Knee Osteoarthritis |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2026-04-01 |
| Primary Completion | 2029-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 30 participants in total. It began in 2026-04-01 with a primary completion date of 2029-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Inclusion Criteria: * • Age 50 or years older. * Chronic pain as indicated by complaints of pain in one or more body regions for 6 months or more. Participants who meet at least one of the following criteria for Osteoarthritis (OA) * Fulfills the American College of Rheumatology (ACR) criteria for symptomatic knee OA and had radiographic evidence of tibiofemoral or patellofemoral OA (defined as the presence of a definite osteophyte in the tibiofemoral compartment and/or the patellofemoral compartment. * Knee pain for \>- 3 months and on most days of the past month * Patient PROMIS Pain Interference score \>=40 (100 mm VAS); * Access to computer or device for telehealth delivery; * Able to walk without cane or assistance. * Psychological distress expressed as depression: Persistent depressive symptomatology (Beck Depression Inventory)\>20 in two consecutive screenings within 2-3 weeks. * Willingness to complete the 3-month study, including twice-a-week Tai Chi sessions and rTMS, with additional 6 and 12 month follow up * Approval to participate in program by patient's primary care provider or another member of their medical team (e.g. cardiologist). * Ability to pass the Physical Activity Readiness Questionnaire (PAR-Q) administered in the telephone screening. * Internet access \>No contraindications to rTMS Exclusion Criteria: * • Change in psychotropic or pain medication during the past four months. This will minimize the amount of symptom change due to medication alterations. * A current diagnosis of mania, hypomania, unstable bipolar disorder, psychotic disorder or a history of psychosis, as noted in electronic medical record. * Dementia, neurological disease, cancer, cardiovascular disease, metabolic disease, renal disease, liver disease, or other serious medical conditions limiting ability to participate in the Tai Chi or Exercise programs, as determined by primary care physicians. * No current medical conditions that limit ability to participate safely in moderate exercise. * Meets criteria for alcohol or drug dependence within the past three months. * Currently practicing Tai Chi
Frequently Asked Questions
Who can join the NCT06906939 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, up to 95 Years, studying Knee Osteoarthritis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06906939 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06906939 currently recruiting?
Yes, NCT06906939 is actively recruiting participants. Visit ClinicalTrials.gov or contact University of California, Los Angeles to inquire about joining.
Where is the NCT06906939 trial being conducted?
This trial is being conducted at Los Angeles, United States.
Who is sponsoring the NCT06906939 clinical trial?
NCT06906939 is sponsored by University of California, Los Angeles. The trial plans to enroll 30 participants.