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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether combining repetitive transcranial magnetic stimulation (rTMS), a non-invasive brain stimulation technique, with Tai Chi can effectively reduce knee pain and depression in people with osteoarthritis. The researchers aim to determine if targeting two brain areas with rTMS, alongside Tai Chi, provides more relief than Tai Chi alone. This trial suits individuals with chronic knee pain from osteoarthritis and moderate to severe depression, who can walk unaided and are willing to participate in Tai Chi sessions. Participants must have internet access for telehealth and no major health issues that would prevent safe exercise. As an Early Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants a chance to contribute to groundbreaking insights.

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.

What prior data suggests that this rTMS technique is safe for treating knee osteoarthritis and depression?

Research has shown that repetitive transcranial magnetic stimulation (rTMS) is generally safe and well-tolerated. Studies have found that when combined with exercises like strengthening the thigh muscles, people with knee osteoarthritis did not report significant side effects. Many participants noticed improvements in pain and movement without major issues. Another study on a specific type of rTMS, called intermittent theta burst stimulation (iTBS), found that participants handled the treatment well, with no serious safety concerns.

For those considering joining a trial involving rTMS, these findings suggest that the treatment is likely safe. However, as with any medical treatment, individual reactions can vary, so discussing any concerns with the trial team is important. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about the use of repetitive transcranial magnetic stimulation (rTMS) and Tai Chi for osteoarthritis because these approaches offer a non-invasive alternative to standard pain management options like NSAIDs and corticosteroid injections. Unlike traditional treatments that primarily address symptoms, rTMS targets the brain's pain processing areas, potentially altering how pain is perceived. Meanwhile, Tai Chi promotes physical activity and joint flexibility without the strain of high-impact exercises. Together, these treatments could offer a holistic approach to managing osteoarthritis pain, reducing reliance on medications and their associated side effects.

What evidence suggests that this trial's treatments could be effective for knee osteoarthritis?

Research has shown that repetitive transcranial magnetic stimulation (rTMS) can help reduce pain in people with knee osteoarthritis. In this trial, participants may receive active rTMS treatment, which stimulates specific brain areas to lessen pain and enhance movement. Studies have found that targeting the brain area controlling movement with rTMS can effectively treat pain linked to knee osteoarthritis. Additionally, research indicates that high-frequency rTMS, combined with exercises for the thigh muscles, can improve pain and movement in those with knee osteoarthritis. While more research is needed, early findings suggest rTMS could be a promising option for managing knee osteoarthritis pain and related symptoms. ^{2 3 6 7 8}

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 can walk on my own without any help.

Approval to participate in program by patient's primary care provider or another member of their medical team (e.g. cardiologist)

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

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 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) 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 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.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40900907/

Effectiveness of high-frequency repetitive transcranial ...

Objective: To assess the effectiveness of high-frequency repetitive transcranial magnetic stimulation (rTMS) in conjunction with quadriceps ...

2.

sciencedirect.com

sciencedirect.com/science/article/pii/S1388245725003189

Accelerated intermittent theta burst transcranial magnetic ...

This study assessed feasibility, safety, and tolerability of accelerated intermittent theta burst stimulation (aiTBS) with effective connectivity-guidance ...

3.

bmjopen.bmj.com

bmjopen.bmj.com/content/15/5/e097293

Repetitive transcranial magnetic stimulation as an adjunct ...

Both groups demonstrated within-group improvements in pain at the postintervention assessment but not at the 3-month follow-up. Function improved only in the AR ...

4.

frontiersin.org

frontiersin.org/journals/neuroscience/articles/10.3389/fnins.2019.00388/full

The Value of High-Frequency Repetitive Transcranial ...

In conclusion, a therapeutic use of motor cortex rTMS is particularly appealing to treat pain associated with knee osteoarthritis, especially ...

5.

bmcmusculoskeletdisord.biomedcentral.com

bmcmusculoskeletdisord.biomedcentral.com/articles/10.1186/s12891-023-07146-7

Effectiveness and mechanism of action of rTMS combined with ...

The purpose of this study is to investigate whether the High-Frequency rTMS combined with quadriceps strength training can improve the pain and function in KOA ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9362826/

Feasibility and safety of combining repetitive transcranial ...

Although pooled data from a recent meta-analysis in chronic pain showed a moderate reduction in pain severity favouring the combined rTMS and ...

7.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40409966/

Repetitive transcranial magnetic stimulation as an adjunct ...

No adverse events were reported. At the postintervention assessment, 80% in the AR+EX group and 75% in the SR+EX group reported an improvement ...

8.

journals.sagepub.com

journals.sagepub.com/doi/10.1177/1759720X251370979

Effectiveness of high-frequency repetitive transcranial ...

Conclusion: High-frequency rTMS combined with quadriceps strength training for 12 weeks can effectively improve pain, muscle strength and joint ...