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Feasibility and Effect of Remotely Supervised Transcranial Direct Current Stimulation With Chair Yoga for Chronic Knee Pain Management in Older Adults With Alzheimer's Disease and Related Dementias.

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 60
Healthy Volunteers: f
View:

• 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.

⁃ 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.

Locations
United States
Arizona
University of Arizona College of Nursing
RECRUITING
Tucson
Time Frame
Start Date: 2025-03-04
Estimated Completion Date: 2026-08-30
Participants
Target number of participants: 40
Treatments
Experimental: Active Chair Yoga paired with active tDCS
Active Chair Yoga paired with active tDCS
Sponsors
Leads: University of Arizona

This content was sourced from clinicaltrials.gov