RightFit
RecruitingEarly Phase 1

A Randomized Pilot rTMS Trial for Knee Arthritis Pain and Depression

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
50 Years to 95 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests rTMS, a treatment that uses magnetic pulses to stimulate the brain, along with Tai Chi. It is for adults age 50 or older with knee arthritis pain and moderate to severe depression. Researchers will check safety and comfort, and whether treatment improves pain and depression.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 50 or older.
  • Pain in one or more body areas for at least 6 months.
  • Meet at least one listed knee arthritis or pain measure: knee arthritis confirmed by medical criteria and X-rays; knee pain for at least 3 months and on most days last month; or a pain impact score of 40 or higher.
  • Have a depression score above 20 on two screenings within 2 to 3 weeks.
  • Have internet access and a computer or device for online visits, and be able to walk without a cane or help.
  • Be willing to join the 3-month study, including twice-weekly Tai Chi and rTMS, with follow-up at 6 and 12 months.
  • Have approval from your medical team and pass a phone screening about being ready for physical activity.
  • Have no medical reason that makes rTMS unsafe for you.

Who can't join

  • Changed medicine for mental health or pain in the past 4 months.
  • Have mania or hypomania (periods of unusually high energy or mood), unstable bipolar disorder, or current or past psychosis (trouble knowing what is real).
  • Have dementia or another serious illness that your doctor says limits your ability to join Tai Chi or exercise.
  • Have a medical condition that makes moderate exercise unsafe.
  • Have met the criteria for alcohol or drug dependence in the past 3 months.
  • Currently practice Tai Chi.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (1)

CA