Recruiting

tDCS & OCY

Sponsor:

University of Arizona

Code:

NCT07303998

Conditions

Alzheimer&Amp;#39;s Disease

Other Dementias

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

Interventions

Active tDCS paired with active online chair yoga

Study Details

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

Study ID

NCT07303998

Start date

Mar 4, 2025

Status verified date

Dec, 2025

Completion date

Aug 30, 2026

Anticipated

Primary completion date

Aug 20, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Active Chair Yoga paired with active tDCS

Active Chair Yoga paired with active tDCS

Interventions

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.

Primary outcome measure

  • Numeric Rating Score (NRS) of Pain [ Time Frame: Baseline (Week 0); after each intervention session (Sessions 1-14 over Weeks 1-4); and end of intervention (Week 4). ]

Central Contacts and Locations

Locations

University of Arizona College of Nursing

Recruiting

Tucson, Arizona, United States, 85721

Contacts

Principal Investigator:

Juyoung Park, Ph.D

More Information

Sponsor

University of Arizona

Last update posted

Dec 26, 2025

Last verified

Dec, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Arizona on 2025-12-26.