Individualized Brain Stimulation to Improve Mobility in Alzheimer's Disease (ISTIM-AD)
Alzheimer Dementia, Presenile Alzheimer Dementia, Aging
About this trial
This is an interventional treatment trial for Alzheimer Dementia focused on measuring Aging
Eligibility Criteria
Inclusion Criteria:
- Men and women aged 65 and older living within supportive housing facilities
- Mild Alzheimer's disease (AD) defined by the combination of 1) at least mild cognitive impairment defined as a modified TICS score of ≤ 34, 2) informant-report of Instrumental Activities of Daily Living impairment as defined as a score of ≥ 6 on the NACC Functional Activities Questionnaire, and 3) a Clinical Dementia Rating score of 1.
Exclusion Criteria:
- Inability to secure informant participation
- Unwillingness to cooperate or participate in the study protocol
- An inability to ambulate without the assistance of another person (canes or walkers allowed)
- A clinical history of stroke, Parkinson's disease or parkinsonian symptoms, multiple sclerosis, normal pressure hydrocephalus, or other neurological conditions outside of mild AD.
- Any report of severe lower-extremity arthritis or physician-diagnosis of peripheral neuropathy
- Use of antipsychotics, anti-seizure, benzodiazepines, or other neuroactive medications
- Severe depression defined by a Center for Epidemiologic Studies Depression scale score greater than 16
- Any report of physician-diagnosis of schizophrenia, bipolar disorder, or other psychiatric illness
- Contraindications to MRI or tDCS, including reported seizure within the past two years, use of neuropsychological-active drugs, the risk of metal objects anywhere in the body, self-reported presence of specific implanted medical devices (e.g., deep brain stimulator, medication infusion pump, cochlear implant, pacemakers, etc.), or the presence of any active dermatological condition, such as eczema, on the scalp
Sites / Locations
- Hebrew Rehabilitation CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Sham Comparator
Personalized tDCS
Active-Sham
Baseline MRIs will enable personalization of tDCS via current flow modeling for optimization to each participant with the goal of generating an average electric field of 0.25 V/m within their identified left dlPFC. The direct current delivered by any one electrode will not exceed 2.0 mA and the total amount of current from all electrodes will not exceed 4 mA. Each 20-minutes session will begin and end with a 60-second ramp up/down of current amplitude to maximize comfort.
The investigators will use an active sham in which very low-level currents (0.5 mA total) will be transferred between electrodes in close proximity on the scalp throughout the entire 20-minute session. This intervention will be optimized to each participant to deliver currents designed to not significantly influence their cortical tissue, but still mimic the cutaneous sensations induced by tDCS.