tDCS + Mindfulness Meditation for Osteoarthritis

Recruiting at 2 trial locations

Overseen By Hyochol Ahn, PhD,RN,MSN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The University of Texas Health Science Center, Houston

Disqualifiers: Brain surgery, Rheumatic disorders, Alcohol abuse, others

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

Compensation: Varies

Number of Visits: 8

Duration: 2 weeks

200 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires that you do not change your current medication regimen for pain throughout the study.

What data supports the effectiveness of this treatment for osteoarthritis?

Research shows that combining transcranial direct current stimulation (tDCS) with mindfulness-based meditation (MBM) significantly reduces pain and improves symptoms in older adults with knee osteoarthritis, with participants reporting high satisfaction and no serious side effects. ^{1 2 3 4 5}

Is tDCS combined with Mindfulness Meditation safe for humans?

Research suggests that transcranial direct current stimulation (tDCS) combined with mindfulness-based meditation (MBM) is generally safe for humans, with mild and temporary side effects like itching and tingling. Studies have shown that participants tolerate this treatment well without serious adverse effects. ^{1 3 6 7 8}

How does the tDCS + Mindfulness Meditation treatment for osteoarthritis differ from other treatments?

This treatment is unique because it combines transcranial direct current stimulation (tDCS), which uses a mild electrical current to stimulate the brain, with mindfulness meditation, a mental practice that focuses on being present and aware. Unlike traditional pain medications, this approach is non-drug and targets pain perception and processing in the brain, offering a novel way to manage osteoarthritis pain without the use of pharmaceuticals. ^{1 2 3 4 5}

What is the purpose of this trial?

The purpose of this study is to determine the effects of active transcranial direct current stimulation (tDCS) paired with active mindfulness-based meditation (MBM) on clinical pain,osteo arthritis (OA)-related clinical symptoms, physiopsychological pain processing and participant satisfaction with treatment in patients with knee OA.

Research Team

Hyochol Ahn, PhD,RN,MSN

Principal Investigator

University of Arizona

Eligibility Criteria

This trial is for English-speaking adults with knee pain from osteoarthritis, who've had an average pain score of at least 30 out of 100 in the past three months. Participants should not plan to change their pain medication during the study and must have access to videoconferencing tools.

Inclusion Criteria

Have no plan to change medication regimens for pain throughout the trial

Can speak and read English

I have knee pain diagnosed as osteoarthritis.

Exclusion Criteria

Alcohol/substance abuse

I have a condition like rheumatoid arthritis, lupus, or fibromyalgia.

I have a history of brain surgery, tumor, seizure, stroke, or metal in my brain.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive active transcranial direct current stimulation (tDCS) paired with mindfulness-based meditation (MBM) or sham interventions for knee osteoarthritis

2 weeks

5 times a week

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of mindfulness, pain intensity, and osteoarthritis symptoms

3 months

3 follow-up assessments (months 1, 2, and 3 post-intervention)

Treatment Details

Interventions

• active tDCS paired with active MBM
• active tDCS paired with sham MBM
• sham tDCS paired with active MBM
• sham tDCS paired with sham MBM

Trial Overview The study tests if a combination of active transcranial direct current stimulation (tDCS) and mindfulness-based meditation (MBM) can reduce knee pain and improve symptoms in osteoarthritis patients compared to placebo treatments.

Participant Groups

Group I: active tDCS paired with active MBM, Experimental Treatment 1 Intervention

Group II: active tDCS paired with sham MBM Active Control 1 Intervention

Group III: sham tDCS paired with active MBM Active Control 1 Intervention

Group IV: sham tDCS paired with sham MBM Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials

974

Recruited

361,000+

University of Arizona

Lead Sponsor

Trials

545

Recruited

161,000+

Florida State University

Lead Sponsor

Trials

234

Recruited

41,100+

National Institute of Nursing Research (NINR)

Collaborator

Trials

623

Recruited

10,400,000+

Findings from Research

A study involving 30 older adults with knee osteoarthritis showed that combining transcranial direct current stimulation (tDCS) with mindfulness-based meditation (MBM) significantly reduced pain and improved overall OA symptoms.

Participants tolerated the treatment well, reporting high satisfaction and no serious side effects, indicating that this combined approach is both safe and potentially effective for managing knee OA pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of combining home-based transcranial direct current stimulation with mindfulness-based meditation for pain in older adults with knee osteoarthritis: A randomized controlled pilot study. Ahn, H., Zhong, C., Miao, H., et al.[2020]

Transcranial direct current stimulation (tDCS) applied to the motor cortex significantly reduced pain severity in older adults with knee osteoarthritis, with effects lasting up to three weeks after treatment.

The study involved 40 participants aged 50 to 70, and tDCS was well-tolerated with no serious adverse effects or cognitive changes reported, indicating its safety for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of transcranial direct current stimulation over primary motor cortex (anode) and contralateral supraorbital area (cathode) on clinical pain severity and mobility performance in persons with knee osteoarthritis: An experimenter- and participant-blinded, randomized, sham-controlled pilot clinical study. Ahn, H., Woods, AJ., Kunik, ME., et al.[2022]

The study involved 30 participants with knee osteoarthritis who received either active transcranial direct current stimulation (tDCS) combined with exercise or a sham treatment for 8 weeks, showing that adding tDCS is safe and feasible.

While both groups experienced pain reduction, only the active tDCS group showed significant improvements in function and pressure pain thresholds, suggesting that tDCS may enhance the benefits of exercise in managing knee osteoarthritis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Addition of transcranial direct current stimulation to quadriceps strengthening exercise in knee osteoarthritis: A pilot randomised controlled trial. Chang, WJ., Bennell, KL., Hodges, PW., et al.[2022]

In a study involving 40 older adults with knee osteoarthritis, transcranial direct current stimulation (tDCS) significantly increased pain thresholds and tolerances, indicating its efficacy in reducing experimental pain sensitivity.

The improvements in experimental pain measures from tDCS were linked to reductions in clinical pain, suggesting that tDCS could be a promising non-invasive treatment for managing chronic pain conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bayesian analysis of the effect of transcranial direct current stimulation on experimental pain sensitivity in older adults with knee osteoarthritis: randomized sham-controlled pilot clinical study. Ahn, H., Suchting, R., Woods, AJ., et al.[2022]

In a double-blind study involving 19 older adults with knee osteoarthritis, the combination of transcranial direct current stimulation (tDCS) and mindfulness-based meditation (MBM) significantly relieved pain compared to a sham treatment.

The active treatment group showed increased oxyhemoglobin activation in brain areas related to pain processing, indicating that tDCS and MBM may effectively modulate pain perception through neural mechanisms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Functional Near-Infrared Spectroscopy to Assess Central Pain Responses in a Nonpharmacologic Treatment Trial of Osteoarthritis. Pollonini, L., Montero-Hernandez, S., Park, L., et al.[2021]

Transcranial direct current stimulation (tDCS) is generally considered safe, with mild and transient adverse effects reported in clinical trials, but the frequency and relationship of these effects with clinical variables remain unclear due to selective reporting bias.

Out of 209 studies reviewed, 117 mentioned adverse effects, with common issues like itching and tingling reported more frequently in the active tDCS group, although these differences were not statistically significant.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review on reporting and assessment of adverse effects associated with transcranial direct current stimulation. Brunoni, AR., Amadera, J., Berbel, B., et al.[2022]

Transcranial Direct Current Stimulation (tDCS) is generally considered safe, but there are concerns that it could lead to significant negative effects in healthy individuals.

The scientific community needs to be alerted about the potential risks of tDCS, emphasizing the importance of protecting healthy volunteers from possible harm.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of transcranial direct current stimulation in healthy participants. Boccard-Binet, S., Sen, A.[2021]

Transcranial Direct Current Stimulation (tDCS) has been shown to be safe, with no reports of Serious Adverse Effects or irreversible injuries across over 33,200 sessions involving more than 1,000 subjects, including vulnerable populations.

Safety assessments indicate that the current densities used in conventional tDCS (≤4 milliamperes) are significantly lower than those that could potentially cause brain injury, suggesting that tDCS protocols are well within safe limits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of Transcranial Direct Current Stimulation: Evidence Based Update 2016. Bikson, M., Grossman, P., Thomas, C., et al.[2022]

References

1. Scotland pubmed.ncbi.nlm.nih.gov

Efficacy of combining home-based transcranial direct current stimulation with mindfulness-based meditation for pain in older adults with knee osteoarthritis: A randomized controlled pilot study. [2020]

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

Efficacy of transcranial direct current stimulation over primary motor cortex (anode) and contralateral supraorbital area (cathode) on clinical pain severity and mobility performance in persons with knee osteoarthritis: An experimenter- and participant-blinded, randomized, sham-controlled pilot clinical study. [2022]

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

Addition of transcranial direct current stimulation to quadriceps strengthening exercise in knee osteoarthritis: A pilot randomised controlled trial. [2022]

4. New Zealand pubmed.ncbi.nlm.nih.gov

Bayesian analysis of the effect of transcranial direct current stimulation on experimental pain sensitivity in older adults with knee osteoarthritis: randomized sham-controlled pilot clinical study. [2022]

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

Functional Near-Infrared Spectroscopy to Assess Central Pain Responses in a Nonpharmacologic Treatment Trial of Osteoarthritis. [2021]

6. England pubmed.ncbi.nlm.nih.gov

A systematic review on reporting and assessment of adverse effects associated with transcranial direct current stimulation. [2022]

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

Safety of transcranial direct current stimulation in healthy participants. [2021]

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

Safety of Transcranial Direct Current Stimulation: Evidence Based Update 2016. [2022]