NCT06906939 · University of California, Los Angeles
A Randomized Pilot rTMS Trial for Knee Arthritis Pain and Depression
What this study is about
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.
View original scientific description
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.
Interventions
DEVICE
repetetive transcranial magnetic stimulation
rTMS treatments will be performed with the MagVenture MagPro X100 stimulator equipped with the Cool-B70 A/P for sham-controlled stimulation. The coil has two sides, one of which is shielded so that no energy is imparted to the brain when the shielded side is applied to the subject's head. Small skin electrodes are applied to the scalp under the coil that impart a small microcurrent to the scalp simulating the sensation of active treatment. The operator receives a code from the device instructing them which side of the coil to use for each subject, ensuring complete treatment blinding.
Primary outcome measures
Adherence
Time frame: 12 weeks (30 treatments
The number of sessions attended by each participant (attendance rate \>80% is considered feasible).
Feasibility
Time frame: 12 weeks
The number of dropouts in each group
Safety
Time frame: 12 weeks
The number of adverse events and side-effects
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Los Angeles, California
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 6, 2026 · Source of record for eligibility and locations