Home-based brain stimulation plus online chair yoga for chronic knee pain in people with Alzheimer's disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot uses a home-based, remotely supervised protocol pairing transcranial direct current stimulation (tDCS) with synchronous online chair yoga (OCY) sessions for community-dwelling older adults with mild-to-moderate Alzheimer's disease and related dementias who report chronic knee pain. Participants receive remotely supervised tDCS and take part in chair-supported yoga designed for older adults, with caregivers assisting as needed. Study measures include feasibility and acceptability metrics along with preliminary outcomes for pain intensity, mobility, mood, and neuropsychiatric symptoms. The intervention is delivered and monitored by investigators at the University of Arizona as a nonpharmacological alternative to opioid-based pain management.

Why it matters

Who can join: the full rules

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.

Where it's running

• University of Arizona College of Nursing
  Tucson, Arizona, United States Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.