Recruiting
Early Phase 1

rTMS with Tai Chi

Sponsor:

UCLA

Code:

NCT06906939

Conditions

Knee Osteoarthritis

Depression

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

Interventions

repetetive transcranial magnetic stimulation

Study Details

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.

Conditions

Knee Osteoarthritis

Depression

Study ID

NCT06906939

Start date

Jun 4, 2026

Status verified date

Jul, 2026

Completion date

Jun 30, 2029

Anticipated

Primary completion date

Jun 30, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: active rTMS

Active treatment to l-DLPFC will consist of 1800 pulses of intermittent theta burst stimulation (iTBS) at 120% MT. Active treatment to M1 will consist of 1500 pulses of 10 Hz stimulation with 20 trains of 10-s on and 30-s intertrain intervals at 100% MT. Intensity of active stimulation at both targets will be ramped up to the target intensity over the first three treatment sessions to increase tolerability.

sham comparator: sham

Sham condition will be programmed by a study technician with treating physician being unaware of the assignment.

Interventions

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 measure

  • Adherence [ Time Frame: 12 weeks (30 treatments ]
  • Feasibility [ Time Frame: 12 weeks ]
  • Safety [ Time Frame: 12 weeks ]

Central Contacts and Locations

Locations

UCLA Semel Institute - Neuropsychiatric Institute (NPI)

Recruiting

Los Angeles, California, United States, 90095

Contacts

Helen Lavretsky, MD, MS

310-794-4619hlavretsky@mednet.ucla.edu

Principal Investigator:

Helen Lavretsky, MD

More Information

Sponsor

University of California, Los Angeles

Last update posted

Jul 6, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of California, Los Angeles on 2026-07-06.