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New treatment option for Alzheimer&Amp;#39;s Disease
Official title Remote tDCS and Chair Yoga for Chronic Knee Pain in Alzheimer's Patients
ClinicalTrials.gov ID: NCT07303998
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 60 and older
You may be able to join if
- (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...
- 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).
You likely can't join if
- (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);
See the full eligibility criteria
Who can join
- (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...
- 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...
- 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.
What rules you out
- (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...
- 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 study team makes the final eligibility decision.
Where it's taking place
- Tucson, Arizona, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 60 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tucson, Arizona, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.