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

NCT07303998 | Recruiting FDA Device

• 1 other identifier: jpark13
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Alzheimer&Amp;#39;s Disease; Other Dementias

Keywords

transcranial direct current stimulation; chair yoga; older adults; Chronic knee pain; Dementias; online chair yoga; seniors

Outcome Measures

Primary Outcomes (1)

• Numeric Rating Score (NRS) of Pain

  Clinical pain intensity will be measured by asking participants to rate their knee pain over the last 24 hours between 0 (no pain) - 10 (worst pain imaginable). The NRS has a reported Cronbach's alpha coefficient of ≥ 0.8 and is a reliable way for measuring knee pain in adults with knee osteoarthritis.

  Baseline (Week 0); after each intervention session (Sessions 1-14 over Weeks 1-4); and end of intervention (Week 4).

Secondary Outcomes (15)

• Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference 4a

  Baseline (Week 0); after each intervention session (Sessions 1-14 over Weeks 1-4); and end of intervention (Week 4).

• Mobilization-Observation-Behavior-Intensity-Dementia Pain Scale (MOBID-2)

  Baseline (Week 0); after each intervention session (Sessions 1-14 over Weeks 1-4); and end of intervention (Week 4).

• ActiGraph Watch

  Continuously assessed from baseline (Week 0) through end of intervention (Week 4).

• The Montreal Cognitive Assessment (MoCA v. 8.1)

  Baseline (Week 0) and end of intervention (Week 4).

• Functional near-infrared spectroscopy (fNIRS) brain imaging

  Baseline (Week 0) and end of intervention (Week 4).

Study Arms (1)

Active Chair Yoga paired with active tDCS

EXPERIMENTAL

Active Chair Yoga paired with active tDCS

Device: Active tDCS paired with active online chair yoga

Interventions

Active tDCS paired with active online chair yoga DEVICE

Active tDCS with a constant current of 2 milli amperes (mA) will be applied for 20 minutes daily for 1 week, and 20 minutes 3 times per week for 3 weeks via the Soterix 1x1 tDCS mini-CT Stimulator device with headgear and saline-soaked surface sponge electrodes. Online chair yoga therapy lasting 30 minutes will be conducted via Zoom by a yoga therapist immediately after each tDCS session.

Also known as: online chair yoga, trans-direct current stimulation

Active Chair Yoga paired with active tDCS

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• 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.
• alcohol/substance use disorder

Sponsors & Collaborators

• University of Arizona: lead

Study Sites (1)

University of Arizona College of Nursing

Tucson, Arizona, 85721, United States

RECRUITING

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MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 13, 2025
• First Posted: December 26, 2025
• Study Start: March 4, 2025
• Primary Completion (Estimated): August 20, 2026
• Study Completion (Estimated): August 30, 2026
• Last Updated: December 26, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)