Randomized pilot of rTMS for knee arthritis pain and depression

A Randomized Pilot rTMS Trial for Knee Arthritis Pain and Depression

This pilot will test whether repetitive transcranial magnetic stimulation (rTMS) paired with a Tai Chi program can reduce knee osteoarthritis pain and depressive symptoms in people aged 50 and older.

Quick facts

• Phase: Early Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 50 Years to 95 Years
• Sex: All
• Sponsor: University of California, Los Angeles (Academic / other)
• Locations: 1 site (Los Angeles, California)
• Trial ID: NCT06906939 on ClinicalTrials.gov

What this trial studies

This randomized early-phase pilot delivers sequential, multi-target rTMS to the primary motor cortex (M1) and left dorsolateral prefrontal cortex (l-DLPFC) alongside a twice-weekly Tai Chi program over three months. Participants are adults 50 and older with symptomatic or radiographic knee osteoarthritis and persistent depressive symptoms. The trial measures changes in pain, function, and mood to determine feasibility, tolerability, and early signals of clinical benefit. The study is conducted at UCLA and includes telehealth components for some study activities.

Who should consider this trial

Good fit: Ideal candidates are people age 50 or older with symptomatic or radiographic knee osteoarthritis and persistent depressive symptoms (BDI >20 on two screenings), who can walk without assistance, have access to a device for telehealth, and are willing to attend rTMS visits and twice-weekly Tai Chi for three months.

Not a fit: Patients without knee osteoarthritis or clinically significant depressive symptoms, those unable to participate in Tai Chi or attend in-person rTMS at UCLA, or those with contraindications to rTMS are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, this approach could reduce knee pain and depressive symptoms and improve daily function and quality of life.

How similar studies have performed: Previous rTMS studies have reduced pain and improved mood in conditions like fibromyalgia and major depression, but sequential stimulation of M1 followed by left DLPFC for knee OA with comorbid depression is a novel approach that has not been systematically tested.

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

Where this trial is running

Los Angeles, California

• UCLA Semel Institute - Neuropsychiatric Institute (NPI) — Los Angeles, California, United States (Recruiting)

Conditions Knee Osteoarthritis; Depression