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RECRUITING

NCT06906939

EARLY_PHASE1

A Randomized Pilot rTMS Trial for Knee Arthritis Pain and Depression

Sponsor: University of California, Los Angeles

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

50 Years - 95 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-04-01

Completion Date

2029-06-30

Last Updated

2026-03-13

Healthy Volunteers

Conditions

Knee Osteoarthritis Depression

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.

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

Locations (1)

UCLA Semel Institute - Neuropsychiatric Institute (NPI)

Los Angeles, California, United States