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NCT07303998 · University of Arizona

Remote tDCS and Chair Yoga for Chronic Knee Pain in Alzheimer's Patients

What this study is about

This study aims to evaluate the feasibility, acceptability, and preliminary effects of a home-based, remotely supervised intervention combining transcranial direct current stimulation (tDCS) and online chair yoga (OCY) to manage chronic knee pain in older adults with Alzheimer's Disease and Related Dementias (ADRD).

View original scientific description

This study aims to evaluate the feasibility, acceptability, and preliminary effects of a home-based, remotely supervised intervention combining transcranial direct current stimulation (tDCS) and online chair yoga (OCY) to manage chronic knee pain in older adults with Alzheimer's Disease and Related Dementias (ADRD). Chronic knee pain is prevalent among individuals with ADRD and is often underdiagnosed and undertreated, contributing to neuropsychiatric symptoms, reduced quality of life, and increased caregiver burden. Current pharmacological options, such as opioids, pose risks of adverse events in this population. tDCS is a safe, noninvasive technique that uses low-intensity electrical current to modulate brain activity and may improve pain perception by targeting central mechanisms. Chair yoga is a mind-body intervention shown to improve pain and mood in older adults, including those with dementia. This study proposes that combining tDCS and OCY may have synergistic benefits in reducing pain and enhancing function. Participants will include older adults aged 60+ with mild to moderate ADRD and chronic knee pain, along with their caregivers. Over four weeks, participants will complete 14 supervised sessions of combined tDCS and OCY at home. Outcomes include feasibility, satisfaction, pain intensity, pain interference, neuropsychiatric symptoms, sleep disturbance, cognitive function, mobility, and quality of life. Neurophysiological measures (e.g., fNIRS, EEG, HF-HRV) will also be assessed to explore underlying mechanisms. This study seeks to lay the foundation for future large-scale randomized controlled trials of home-based nonpharmacological interventions for chronic pain in ADRD.

Who can participate

This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.

Inclusion criteria

  • (participants):
  • Live in the community (not institutionalized).
  • Have a diagnosis of Alzheimer's disease and related dementias (ADRD), including Alzheimer's disease, Lewy Body Dementia, Vascular Dementia, or Multiple Etiology Dementias (MED) diagnosed by a neurologist or other healthcare provider.
  • Be in mild to moderate ADRD, as indicated by a Quick Dementia Rating Scale (QDRS) score between 6 and 20.5.
  • Score above 10 on the Montreal Cognitive Assessment (MoCA).
  • Experience chronic knee pain (caregiver-reported average pain in the past 3 months \> 40 out of 100).
  • Have no planned changes to their medication regimen or other interventions for knee pain during the trial.
  • Agree to participate in both transcranial direct current stimulation (tDCS) and online chair yoga (OCY).
  • Be able to ambulate independently with minimal assistance (e.g., using a cane or walker) for participation in OCY and the Timed Up and Go (TUG) test. - -- Be English-speaking and able to understand verbal instructions (literacy not required).
  • Be able to consent for themselves or identify a legally authorized representative who can provide written informed consent.
  • Exhibit neuropsychiatric symptoms (e.g., apathy, agitation).
  • Be naïve to yoga and tDCS.

Exclusion criteria

  • (participants):
  • a history of brain surgery, brain tumor, head trauma, seizure/epilepsy, stroke, cancer affecting the head, or intracranial metal implantation;
  • systemic rheumatic disorders, including rheumatoid arthritis, systemic lupus erythematosus, or fibromyalgia;
  • prosthetic knee replacement or non-arthroscopic surgery to the affected knee;
  • compromised skin integrity on the head in the area where electrodes will be placed;
  • serious comorbidities that preclude participation in tDCS or OCY (e.g., heart failure \[level IV\] causing shortness of breath on exertion);
  • hospitalization within the preceding year for neuropsychiatric illness that would impact knee pain or interfere with study procedures;
  • use of another neurostimulation device (e.g., spinal cord stimulator, cardio-stimulator, or implanted cardioverter-defibrillator). Inclusion Criteria (caregivers): A caregiver is defined in this study as the person who provides care and assistance to a patient with ADRD (e.g., helping with daily activities, managing medications, ensuring safety).
  • Caregivers must be at least 18 years old
  • have provided care and assistance to the patient for at least 10 hours per week at the time of enrollment
  • anticipate continuing to provide care and assistance for the next 4 months (until the study ends)
  • be willing to receive tDCS training, administer home-based tDCS sessions, and assist the patient in attending OCY sessions
  • have access to a reliable Internet connec¬tion for secure videoconferencing for real-time remote supervision
  • English-speaking caregivers who can understand verbal instructions. Exclusion Criteria (caregivers):
  • alcohol/substance use disorder
  • inability to understand English
  • disability that would prevent assisting patients with ADRD from participating in tDCS and OCY (e.g., blindness, deafness)
  • unwillingness to provide care and assistance to patients until the study is completed.
  • If caregiver does not meet the inclusion/exclusion criteria, the participant will not be accepted into the study.

Where

  • Tucson, Arizona

Frequently asked questions

What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Data: ClinicalTrials.gov · synced Dec 26, 2025 · Source of record for eligibility and locations

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1 of 40 participants interested
3% interest

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Tucson

Arizona

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What participation can include

  • Study-related care provided by the research team
  • Close monitoring by medical professionals
  • Possible compensation for time and travel*
  • The option to withdraw at any time
  • Contributing to medical research that may help future patients

*Compensation varies by study. Confirm details with coordinator.

Typical next steps

  1. 1.Submit this form
  2. 2.Phone screening
  3. 3.In-person assessment if eligible
  4. 4.Begin participation

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Alzheimer&Amp;#39;s Disease Treatment Options in Tucson, Arizona

If you're searching for Alzheimer&Amp;#39;s Disease treatment in Tucson, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Tucson and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Alzheimer&Amp;#39;s Disease. All study-related care is provided at no cost to participants.

Local Sites
1 locations in Arizona
Now Enrolling
Up to 40 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Alzheimer&Amp;#39;s Disease?

Potential Benefits

  • Access to new treatment approaches before public availability
  • Close monitoring by experienced medical professionals
  • Study-related care provided at no cost
  • Contribute to medical research for Alzheimer&Amp;#39;s Disease

What to Expect

  • Initial screening to determine eligibility
  • Regular check-ups and monitoring visits
  • Possible compensation for time and travel
  • You can withdraw at any time

Frequently Asked Questions About This Alzheimer&Amp;#39;s Disease Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT07303998. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.