NCT07303998

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

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: University of Arizona · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Older adults with ADRD frequently experience chronic pain, particularly knee pain, which is associated with worse behavioral symptoms and faster cognitive decline. Despite its impact, pain is often inadequately treated in this population due to communication difficulties and the risks associated with pharmacological treatments, especially opioids. Transcranial direct current stimulation (tDCS) is a promising nonpharmacological therapy that delivers low-intensity electrical current to modulate cortical excitability. Research suggests that tDCS can reduce clinical and experimental pain and improve pain processing, particularly when targeted to the motor cortex. Our group has demonstrated the safety and efficacy of home-based, remotely supervised tDCS in older adults, including those with ADRD. Chair yoga (CY), a modified yoga intervention involving seated or chair-supported postures, is also safe and effective for older adults with chronic pain and cognitive impairment. CY has demonstrated benefits in reducing pain, improving mood, and promoting physical activity with minimal risk of falls. Evidence suggests that yoga interventions may enhance central pain modulation and reduce neuropsychiatric symptoms. This pilot study tests a novel combination of tDCS and online CY (OCY) in a home-based setting. We hypothesize that combining tDCS and OCY will reduce chronic knee pain and improve related symptoms in older adults with ADRD. Participants will be recruited from geriatric outpatient clinics and community settings. Eligible participants will be 60 years or older, have mild to moderate ADRD, and experience chronic knee pain. The intervention will include 14 sessions over four weeks. All sessions will be supervised remotely via a secure videoconferencing platform. Primary outcomes are feasibility, acceptability, and satisfaction, assessed through recruitment, adherence, dropout rates, and participant feedback. Secondary outcomes include reductions in knee pain (measured by Numerical Rating Scale and MOBID-2), pain interference (PROMIS Pain Interference 4a), sleep disturbance (ActiGraph), neuropsychiatric symptoms (Neuropsychiatric Inventory Questionnaire), cognitive function (Montreal Cognitive Assessment and Cognivue), mobility (Timed Up and Go), and quality of life (QOL-AD). Exploratory neurophysiological outcomes will include functional near-infrared spectroscopy (fNIRS) to assess pain-related brain activity, EEG for neural pain signatures, and high-frequency heart rate variability (HF-HRV) for autonomic function. This study will help determine the feasibility and potential effects of a scalable, home-based tDCS+OCY protocol, with the goal of informing future large-scale trials and advancing personalized, nonpharmacological pain care in ADRD.

Conditions

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

Interventions

Type	Name	Description
DEVICE	Active tDCS paired with active online chair yoga	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.

Timeline

• Start date: 2025-03-04
• Primary completion: 2026-08-20
• Completion: 2026-08-30
• First posted: 2025-12-26
• Last updated: 2025-12-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study