Mindfulness + tDCS to Reduce Urgency Incontinence in Women

Overseen By Cynthia Conklin, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Cynthia Conklin

Disqualifiers: Cognitive impairment, Urinary retention, Interstitial cystitis, others

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

Compensation: Varies

Number of Visits: 7

Duration: 7 weeks

61 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests mindfulness exercises and gentle brain stimulation to help older women with urge urinary incontinence. These treatments aim to reduce urgency and leakage by helping women manage their body's reactions and improve brain control over bladder signals.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on non-drug treatments, so it's best to ask the trial organizers for more details.

What data supports the effectiveness of the treatment Mindfulness, Mindfulness-Based Interventions, Mindfulness-Based Stress Reduction, Mindfulness-Based Cognitive Therapy, Transcranial direct current stimulation, tDCS, HD-tDCS, High Definition Transcranial Direct Current Stimulation?

Research shows that combining mindfulness practices with transcranial direct-current stimulation (tDCS) can improve symptoms in people with chronic migraine, leading to better attention and pain relief. Additionally, mindfulness-based therapies have been effective in reducing anxiety and depression in cancer patients, suggesting potential benefits for other conditions as well. ^{1 2 3 4 5}

Is transcranial direct current stimulation (tDCS) safe for humans?

Transcranial direct current stimulation (tDCS) is generally considered safe for humans, with mild and temporary side effects like itching, tingling, and headaches. No serious or lasting harm has been reported in over 33,200 sessions across various studies, even in potentially vulnerable groups like children and the elderly. ^{6 7 8 9 10}

How does the treatment of Mindfulness and Transcranial Direct Current Stimulation differ from other treatments?

This treatment is unique because it combines mindfulness practices, which use mental exercises to influence brain activity, with transcranial direct current stimulation (tDCS), a non-invasive method that uses electrical currents to enhance brain plasticity. This combination aims to create synergistic effects that may improve cognitive function and reduce stress more effectively than either treatment alone. ^{2 5 11 12 13}

Research Team

Cynthia Conklin, PhD

Principal Investigator

University of Pittsburgh

Becky Clarkson, PhD

Principal Investigator

University of Pittsburgh

Eligibility Criteria

Inclusion Criteria

Female; 40+ years old

Self-report situational urgency in at least 4 of 15 common scenarios

At least 2 leaks/week

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo 7 sessions of mindfulness training, transcranial direct current stimulation (tDCS), or a combination of both, with 4 urgency-cue exposure training sessions.

7 weeks

7 sessions (in-person)

Follow-up

Participants are monitored for changes in urgency and compliance with study procedures, including a mail-in follow-up 1 week post-training.

4 weeks

Mail-in follow-up

Treatment Details

Interventions

• Mindfulness
• Transcranial direct current stimulation

Participant Groups

Group I: Transcranial Direct Current Stimulation (tDCS) Experimental Treatment 1 Intervention

Transcranial direct current stimulation targeting the dorsolateral prefrontal cortex

Group II: Mindfulness Training Experimental Treatment 1 Intervention

Mindfulness training

Group III: Mindfulness + tDCS Experimental Treatment 2 Interventions

Mindfulness training with transcranial direct current stimulation targeting the dorsolateral prefrontal cortex

Mindfulness is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Mindfulness-Based Interventions for:

• Substance Abuse Treatment
• Anxiety Disorders
• Depression

Approved in European Union as Mindfulness-Based Stress Reduction for:

• Stress Management
• Anxiety Disorders
• Chronic Pain

Approved in Canada as Mindfulness-Based Cognitive Therapy for:

• Depression
• Anxiety Disorders
• Substance Abuse Treatment

Who Is Running the Clinical Trial?

Cynthia Conklin

Lead Sponsor

Trials

2

Recruited

100+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Findings from Research

In a pilot study involving 30 female patients with chronic migraine, combining mindfulness sessions with anodal transcranial direct-current stimulation (tDCS) over the left dorsolateral prefrontal cortex significantly improved migraine-related outcomes compared to a sham treatment.

The active treatment group showed better results in all evaluated measures, particularly in the Headache Impact Test (HIT-6), indicating that this combined approach may enhance attention and provide analgesic benefits for chronic migraine sufferers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Synergism of Mindfulness Practice Associated With Transcranial Direct-Current Stimulation in Chronic Migraine: Pilot, Randomized, Controlled, Double-Blind Clinical Trial. Pimenta, LDS., de Araújo, ELM., Silva, JPDS., et al.[2021]

Mindfulness-Based Stress Reduction (MBSR) has been shown to improve mental health in 11 studies compared to waitlist controls or treatment as usual, demonstrating its efficacy as a therapeutic intervention.

Mindfulness-Based Cognitive Therapy (MBCT) effectively reduces the risk of depressive relapse, showing similar efficacy to treatment as usual in two studies, indicating its potential as a preventive measure for depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based stress reduction and mindfulness-based cognitive therapy: a systematic review of randomized controlled trials. Fjorback, LO., Arendt, M., Ornbøl, E., et al.[2022]

Over the past two decades, there has been a significant increase in randomized controlled trials (RCTs) on mindfulness, with 1389 publications showing a near-exponential growth, particularly in the United States, United Kingdom, and Netherlands.

The most common mindfulness modalities studied include acceptance-based therapy and mindfulness-based stress reduction, with a notable rise in remote delivery methods, indicating a shift towards more accessible mindfulness interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized Controlled Trials of Mindfulness and Acceptance-Based Interventions Over the Past Two Decades: A Bibliometric Analysis. Ma, Y., Kraemer, KM., Lyu, J., et al.[2022]

Mindfulness-based therapy (MBT) significantly reduces symptoms of anxiety and depression in adult cancer patients and survivors, with moderate effect sizes observed in both nonrandomized studies (0.60 for anxiety, 0.42 for depression) and randomized controlled trials (0.37 for anxiety, 0.44 for depression).

The systematic review included 22 studies with a total of 1,403 participants, indicating that while the quality of studies varied, there is promising evidence from higher-quality randomized controlled trials supporting the efficacy of MBT in improving mental health outcomes for cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of mindfulness-based therapy on symptoms of anxiety and depression in adult cancer patients and survivors: a systematic review and meta-analysis. Piet, J., Würtzen, H., Zachariae, R.[2022]

The review analyzed 10 randomized clinical trials involving 461 participants that combined mind-body therapies (like meditation and mindfulness) with transcranial direct current stimulation (tDCS), a technique that enhances brain activity and neuroplasticity.

The combination of MBTs and tDCS shows promise for improving treatment outcomes, but the studies varied widely in design and population, indicating a need for more standardized protocols in future research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Insights and Future Directions on the Combined Effects of Mind-Body Therapies with Transcranial Direct Current Stimulation: An Evidence-based Review. Rebello-Sanchez, I., Vasquez-Avila, K., Parente, J., et al.[2023]

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) 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]

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Effects of Synergism of Mindfulness Practice Associated With Transcranial Direct-Current Stimulation in Chronic Migraine: Pilot, Randomized, Controlled, Double-Blind Clinical Trial. [2021]

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

Mindfulness-based stress reduction and mindfulness-based cognitive therapy: a systematic review of randomized controlled trials. [2022]

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

Randomized Controlled Trials of Mindfulness and Acceptance-Based Interventions Over the Past Two Decades: A Bibliometric Analysis. [2022]

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

The effect of mindfulness-based therapy on symptoms of anxiety and depression in adult cancer patients and survivors: a systematic review and meta-analysis. [2022]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Insights and Future Directions on the Combined Effects of Mind-Body Therapies with Transcranial Direct Current Stimulation: An Evidence-based Review. [2023]

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

Transcranial Direct Current Stimulation Provides no Additional Benefit to Improvements in Self-Reported Craving Following Mindfulness-Based Relapse Prevention. [2023]

7. England pubmed.ncbi.nlm.nih.gov

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

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

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

9. England pubmed.ncbi.nlm.nih.gov

Mindfulness-Based Relapse Prevention and Transcranial Direct Current Stimulation to Reduce Heavy Drinking: A Double-Blind Sham-Controlled Randomized Trial. [2020]

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

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

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

Intervention of Fluency and Anxiety in Mindfulness Training of Shooting. [2023]

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

Enhancing Cognition in Older Persons with Depression or Anxiety with a Combination of Mindfulness-Based Stress Reduction (MBSR) and Transcranial Direct Current Stimulation (tDCS): Results of a Pilot Randomized Clinical Trial. [2022]

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

Linguistic analysis to assess the effect of a mindfulness intervention on self-change for adults in substance use recovery. [2021]