Remote tDCS and Chair Yoga for Chronic Knee Pain in Alzheimer's Patients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorUniversity of Arizona
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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;
Trial design
Design model
Single group
Treatments tested in this trial
Active tDCS paired with active online chair yoga
DeviceActive 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.
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: Active Chair Yoga paired with active tDCSExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
Baseline (Week 0); after each intervention session (Sessions 1-14 over Weeks 1-4); and end of intervention (Week 4).Secondary outcomes
1
Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference 4a
The PROMIS Pain Interference 4a measures pain's impact on daily activities, with four items rated on a 5-point scale. Patients will self report this data based on their activities from the last 7 days. This tool has high reliability with a Cronbach's alpha \~0.90.
Time frame
Baseline (Week 0); after each intervention session (Sessions 1-14 over Weeks 1-4); and end of intervention (Week 4).2
Mobilization-Observation-Behavior-Intensity-Dementia Pain Scale (MOBID-2)
The MOBID-2 asks caregivers to evaluates the pain of participants during specific activities(guiding hands together, turning in bed, sitting at bedside, etc.) and at specific parts of the body (head, mouth, neck, heat lungs, chest wall, etc), with a score range of 0-10; scores over 2 are clinically significant. The MOBID-2 shows high reliability with a Cronbach's alpha 0.86-0.89.
Time frame
Baseline (Week 0); after each intervention session (Sessions 1-14 over Weeks 1-4); and end of intervention (Week 4).3
ActiGraph Watch
The ActiGraph wGT3X-BT and ActiLife software objectively measures sleep disturbance. Wrist actigraphy is a valid and reliable tool for assessing sleep in patients with ADRD. Patients will be asked to wear the watch on their nondominant wrist, with caregiver assistance. Actigraphy data are analyzed to calculate sleep outcomes, including total sleep time, wake time, and daytime naps, using the standard algorithm in ActiLife software without additional hand scoring.
Time frame
Continuously assessed from baseline (Week 0) through end of intervention (Week 4).4
The Montreal Cognitive Assessment (MoCA v. 8.1)
MoCA is a 30-point test that includes 12 subtasks that cover a total of 8 cognitive domains (e.g., memory, orientation, attention/concentration, executive function), with scores ranging 0-30, with higher scores indicating better global cognitive performance. The MoCA features educational correction by the addition of 1 point for the patient with less than a 12th-grade education. The MoCA has high internal reliability (Cronbach α = .83), high test-retest reliability (ICC = 0.92), high interrater reliability (ICC = .81), and high content validity (r = .87).
Time frame
Baseline (Week 0) and end of intervention (Week 4).Sponsors and contacts
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Source ClinicalTrials.gov