NCT07303998 · RECRUITING

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

This trial is testing a home-based combination of transcranial direct current stimulation (tDCS) — a gentle, non-invasive brain stimulation device — and online chair yoga as a way to manage chronic knee pain in people with Alzheimer's disease or related dementias. It is a Phase NA feasibility study, meaning researchers are checking whether the approach is practical and acceptable before testing it in a larger trial. It is not yet proven or approved.

Eligibility criteria

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.

The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.

Eligibility criteria as of 2025-12-26

View full record on ClinicalTrials.gov

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