rTMS + Tai Chi for Osteoarthritis

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: University of California, Los Angeles

Must not be taking: Psychotropics, Pain medications

Disqualifiers: Bipolar, Psychosis, Dementia, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 24

Duration: 12 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does require that you haven't changed your psychotropic or pain medications in the past four months. This means you should be stable on your current medications before joining the trial.

Is rTMS safe for humans?

Repetitive Transcranial Magnetic Stimulation (rTMS) is generally considered safe, with guidelines established to minimize risks. While it can cause seizures in rare cases, other side effects like cognitive changes are possible but not well understood. Safety guidelines have been developed and updated to ensure safe use in both research and clinical settings. ^{1 2 3 4 5}

How is the treatment rTMS + Tai Chi for osteoarthritis different from other treatments?

The treatment combines repetitive transcranial magnetic stimulation (rTMS), a non-invasive method that uses magnetic fields to stimulate nerve cells in the brain, with Tai Chi, a gentle form of exercise. This combination is unique because rTMS is typically used for neurological conditions and not commonly for osteoarthritis, potentially offering a novel approach to managing symptoms by improving balance and physical function. ^{2 6 7 8 9}

What data supports the effectiveness of the treatment Repetitive Transcranial Magnetic Stimulation (rTMS) for osteoarthritis?

Research shows that rTMS can help improve motor function and brain activity in stroke patients, suggesting it might also help with conditions like osteoarthritis by promoting brain and body coordination. ^{3 7 10 11 12}

Are You a Good Fit for This Trial?

This trial is for individuals over 50 with knee osteoarthritis and persistent depression, who can walk unaided and are willing to attend Tai Chi sessions. They must have chronic pain, a high depression score, internet access for telehealth, and no recent medication changes or serious health conditions that would limit participation.

Inclusion Criteria

I have been diagnosed with knee osteoarthritis according to ACR criteria.

I can walk on my own without any help.

I am willing to attend Tai Chi and rTMS sessions for 3 months and follow up.

Exclusion Criteria

I haven't changed my mental health or pain medication in the last 4 months.

I don't have any serious health conditions that would stop me from doing Tai Chi or exercise.

I have been diagnosed with or have a history of mania, bipolar disorder, or psychosis.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive rTMS treatment combined with Tai Chi intervention for knee OA pain and depression

12 weeks

24 sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Repetitive Transcranial Magnetic Stimulation

Trial Overview The study tests whether repetitive transcranial magnetic stimulation (rTMS) combined with Tai Chi can reduce pain and depression in knee arthritis patients. It compares the effects of stimulating two brain areas versus one area plus a sham treatment.

How Is the Trial Designed?

Group I: active rTMS Experimental Treatment 1 Intervention

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.

Group II: sham Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

University of California, Los Angeles

Lead Sponsor

Trials

1,594

Recruited

10,430,000+

Published Research Related to This Trial

Repetitive transcranial magnetic stimulation (rTMS) has not been thoroughly studied for side effects, with the main known risk being the acute production of seizures.

While tissue damage from rTMS is unlikely, there are concerns about potential cognitive effects and the possibility of long-term changes in brain function that have not yet been fully understood.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Side effects of repetitive transcranial magnetic stimulation. Wassermann, EM.[2005]

Repetitive magnetic stimulation (rTMS) is a non-invasive and painless technique that can effectively activate specific areas of the brain, making it useful for studying language, memory, and visual perception.

rTMS shows potential therapeutic benefits for conditions like movement disorders and depression, but there are safety considerations regarding its potential to induce seizures, which are addressed in the study.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Repetitive transcranial magnetic stimulation. Possibilities, limits and safety aspects]. Brandt, SA., Ploner, CJ., Meyer, BU.[2019]

Repetitive transcranial magnetic stimulation (rTMS) has gained popularity for its ability to modulate brain activity, but safety considerations are crucial, especially with the recent updates to safety guidelines published in 2021.

The guidelines emphasize the importance of screening for risks, monitoring for adverse events, and specific safety measures when using rTMS, particularly in patients with conditions like stroke and traumatic brain injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety Review for Clinical Application of Repetitive Transcranial Magnetic Stimulation. Kim, WS., Paik, NJ.[2023]

Repetitive transcranial magnetic stimulation (rTMS) significantly improved cognitive function in older patients with mild to moderate Alzheimer's disease, based on a meta-analysis of seven randomized controlled trials involving 194 participants.

rTMS is considered a safe and well-tolerated alternative intervention for cognitive impairment, showing a moderate effect size in enhancing cognition compared to sham treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of repetitive transcranial magnetic stimulation on improvement of cognition in elderly patients with cognitive impairment: a systematic review and meta-analysis. Cheng, CPW., Wong, CSM., Lee, KK., et al.[2018]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Low-frequency rTMS promotes use-dependent motor plasticity in chronic stroke: a randomized trial. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Long-term effect of motor cortical repetitive transcranial magnetic stimulation [correction]. [2013]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Trends of Repetitive Transcranial Magnetic Stimulation From 2009 to 2018: A Bibliometric Analysis. [2020]

4. Switzerland pubmed.ncbi.nlm.nih.gov

The Effect of Repetitive Transcranial Magnetic Stimulation on Lower-Limb Motor Ability in Stroke Patients: A Systematic Review. [2021]

5. Philippines pubmed.ncbi.nlm.nih.gov

Efficacy of Repetitive Transcranial Magnetic Stimulation (rTMS)in Inducing Weight Loss among Obese Filipino Patients:A Randomized Controlled Trial. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Side effects of repetitive transcranial magnetic stimulation. [2005]

7. Germany pubmed.ncbi.nlm.nih.gov

[Repetitive transcranial magnetic stimulation. Possibilities, limits and safety aspects]. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Relationship between transcranial magnetic stimulation and percutaneous electrical stimulation in determining the quadriceps central activation ratio. [2016]

9. Korea (South) pubmed.ncbi.nlm.nih.gov

Safety Review for Clinical Application of Repetitive Transcranial Magnetic Stimulation. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

The Effects of Repetitive Transcranial Magnetic Stimulation on Standing Balance and Walking in Older Adults with Age-related Neurological Disorders: A Systematic Review and Meta-analysis. [2023]

11. England pubmed.ncbi.nlm.nih.gov

Effects of repetitive transcranial magnetic stimulation on improvement of cognition in elderly patients with cognitive impairment: a systematic review and meta-analysis. [2018]

12. Sweden pubmed.ncbi.nlm.nih.gov

Effects of repetitive trascranial magnetic stimulation on repetitive facilitation exercises of the hemiplegic hand in chronic stroke patients. [2018]