An interventional study of transcranial direct current stimulation and sham stimulation in Apathy, Brain Stimulation and Dementia, sponsored by Hebrew SeniorLife. Not yet recruiting. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2026-10-28.
Sponsored by Hebrew SeniorLife · Not applicable, Interventional, and Treatment
Apathy is one of the most common and undertreated neurobehavioral symptoms in older adults with dementia. It is associated with reduced motivation and engagement in daily activities, and may contribute to faster cognitive and functional decline. Currently, there are no approved pharmacologic treatments for apathy, and many behavioral interventions are difficult for individuals with apathy to initiate and sustain.
This ISAC-funded pilot study will examine the feasibility of a home-delivered, network-based transcranial direct current stimulation intervention designed to target and non-invasively stimulate brain regions involved in motivation and goal-directed behavior, including the dorsolateral prefrontal cortex and anterior cingulate cortex. The study will assess feasibility, safety, adherence of this intervention for older adults with dementia and apathy, and obtain preliminary data of clinical and neurophysiological measures. The team has submitted the IRB application, which is currently pending review, and has posted a position to hire a new research assistant who will support recruitment, study coordination, and intervention delivery. These start-up activities will help prepare the team to launch participant enrollment once regulatory approvals and staffing are in place.
2,372 studies on the registry are indexed under Dementia; 574 are open to participants now.
This study's planned enrollment of 20 is below the median of 90 across 1,758 interventional studies indexed under Dementia.
Browse Dementia studies →Hebrew SeniorLife is the lead sponsor of 38 studies on the registry; 7 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 2 (40%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in this arm will receive the real tDCS intervention.
Device: transcranial direct current stimulation
Participants in this arm will receive the sham stimulation as control.
Device: sham stimulation
tDCS can safely and selectively modulate cortical excitability (specifically neuronal firing likelihood) by transferring weak electrical currents between scalp electrodes. 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 in this study.
sham stimulation will implement the same protocol of the tDCS intervention; however, only very low-level currents (no more than 0.5 mA) are transferred between the same electrodes used for the tDCS throughout the 20-minute session. This strategy effectively mimics the cutaneous sensations and skin redness induced by creating only micro cortical electric fields.
Participant Retention Rate
The metrics measures the compliance of the intervention participation by calculating the percentage of enrolled participants who complete the study, relative to the total number of enrolled participants.
Time frame: Up to 2 weeks (from the first stimulation session through the immediate post-intervention assessment)
Blinding Efficacy
Blinding efficacy will be assessed by asking participants to guess their treatment assignment (active, sham, or unsure) at the end of the intervention and calculating the percentage of participants who correctly identify their assigned group, incorrectly identify their assigned group, or report being unsure.
Time frame: Immediately after the first session of stimulation, and immediately after 5 sessions of stimulation
Side Effects
Side effects will be assessed using a standardized questionnaire documenting the occurrence, type, and severity of side effects associated with tDCS (e.g., tingling, itching, burning sensations, headache, or skin irritation). Results will be summarized as the percentage of participants reporting each side effect and its severity.
Time frame: Up to 2 weeks (from the first stimulation session through the immediate post-intervention assessment)
Change in Apathy Evaluation Scale - Informant Version (AES-I) Score
Apathy will be assessed using the 18-item Apathy Evaluation Scale - Informant Version (AES-I), completed by a knowledgeable informant or study partner. Each item is rated on a 4-point scale, yielding a total score ranging from 18 to 72, with higher scores indicating greater apathy. Changes in total scores from baseline will be used to evaluate changes in apathy severity.
Time frame: Baseline and approximately Week 2 (within 3 days after the final stimulation session)
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function Score
Physical function will be assessed using the 6-item PROMIS Physical Function Short Form (6a). Raw scores range from 6 to 30 and will be converted to standardized T-scores, with higher scores indicating better physical functioning. Changes from baseline will be evaluated.
Time frame: Baseline and approximately Week 2 (within 3 days after the final stimulation session)
Change in PROMIS Depression Score
The 8-item PROMIS Depression Short Form (8a) will measure depressive symptoms, as completed by participants. Raw scores range from 8 to 40 and will be converted to standardized T-scores, with higher scores indicating greater depressive symptom severity.
Time frame: Baseline and approximately Week 2 (within 3 days after the final stimulation session)
Change in PROMIS Ability to Participate in Social Roles and Activities Score
Participation in social roles and activities will be assessed using PROMIS short-form questionnaires (8a and 4a), primarily completed by participants, with caregiver-proxy assessments used when necessary. Raw scores range from 8 to 40 for the 8a form and 4 to 20 for the 4a form. Scores will be converted to standardized T-scores, with higher scores indicating better ability to participate in social roles and activities.
Time frame: Baseline and approximately Week 2 (within 3 days after the final stimulation session)
Change in Montreal Cognitive Assessment (MoCA) Score
This metric will measure global cognitive function. Total scores range from 0 to 30, with higher scores indicating better cognitive function. Changes from baseline will be evaluated.
Time frame: Baseline and approximately Week 2 (within 3 days after the final stimulation session)
Change in Alpha-Band Resting-State Electroencephalography (EEG) Functional Connectivity Between anterior cingulate cortex (ACC) and dorsolateral prefrontal cortex (DLPFC)
Resting-state electroencephalography (EEG) will be used to assess alpha-band (8-13 Hz) functional connectivity between the anterior cingulate cortex (ACC) and dorsolateral prefrontal cortex (dlPFC). Functional connectivity will be quantified using the weighted Phase Lag Index (wPLI), with values ranging from 0 to 1 and higher values indicating stronger functional coupling between these regions.
Time frame: Baseline and approximately Week 2 (within 3 days after the final stimulation session)
Caregiver-Reported Facilitators and Barriers to tDCS Intervention Implementation
Semi-structured interviews will be conducted with caregivers following the final tDCS session to identify perceived facilitators, barriers, and opportunities for improving the intervention. Guided by the Behavior Change Wheel framework, interviews will explore factors related to capability (physical and psychological), opportunity (physical and social), and motivation (reflective and automatic). Interview responses will be analyzed qualitatively to identify recurring themes related to intervention feasibility, acceptability, and potential improvements.
Time frame: Within 3 days after the final stimulation session.
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Hebrew SeniorLife