ApathyNCT07900191
Network-based tDCS for Apathy
A study testing transcranial direct current stimulation in people with Apathy and Brain Stimulation, run by Hebrew SeniorLife.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Apathy, Brain Stimulation, Dementia
- What is being tested?
- transcranial direct current stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 10 Nov 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- age ≥65 years;
- English communication sufficient for procedures;
- a documented diagnosis of dementia;
- with Apathy Evaluation Scale by (by informant/caregiver) (AES-I) score ≥36.
Who cannot join
- acute medical conditions requiring hospitalization within the past month;
- diagnosis of neurological disorders other than dementia that interfere with apathy or functional assessment (e.g., Parkinson's disease);
- moderate to severe dementia (i.e., Functional Assessment Staging Tool (FAST) ≥6);
- receiving hospice care;
- severe vision or hearing deficits;
- uncontrolled hypertension;
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- recreational drug or alcohol abuse;
- hemiparesis from stroke;
- severe depression as assessed by Geriatric Depression Scale-30 score ≥20;
- contraindications to tDCS (e.g., implanted brain medical devices), or skin conditions (e.g., eczema) under the target of tDCS;
- medications interfering with the effects of tDCS (e.g., benzodiazepine).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Chan Mi Park, MD, MPH contact
About this study
Official title: Using Network-based tDCS Intervention to Alleviate Apathy in Older Adults With Dementia
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.
- Conditions
- Apathy, Brain Stimulation, Dementia
- Being tested
- transcranial direct current stimulation, sham stimulation
- Keywords
- tDCS, EEG, apathy
- Medical subject headings
- Lethargy, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial direct current stimulationDevice
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 stimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| tDCS arm | Experimental | Participants in this arm will receive the real tDCS intervention. Receives: Device: transcranial direct current stimulation |
| sham arm | Sham comparator | Participants in this arm will receive the sham stimulation as control. Receives: Device: sham stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 2 weeks (from the first stimulation session through the immediate post-intervention assessment)
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and approximately Week 2 (within 3 days after the final stimulation session)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2026
- Study start10 Nov 2026 (estimated)
- Primary completion31 Oct 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ApathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hebrew SeniorLife
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07900191
- Sponsor's protocol ID
- Pro00094182
- Status last verified
- Oct 2026
- First submitted
- 9 Oct 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Network-based tDCS Intervention to Alleviate Apathy in Older Adults With Dementia
- ClinicalTrials.gov ID
- NCT07900191
- Acronym / sponsor ID
- Pro00094182
- Conditions
- Apathy, Brain Stimulation, Dementia
- Keywords
- tDCS, EEG, apathy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Hebrew SeniorLifeUniversity, hospital or other
- Study start
- 10 Nov 2026 (estimated)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 28 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tDCS arm | Experimental | Device: transcranial direct current stimulationParticipants in this arm will receive the real tDCS intervention. |
| sham arm | Sham comparator | Device: sham stimulationParticipants in this arm will receive the sham stimulation as control. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- age ≥65 years;
- English communication sufficient for procedures;
- a documented diagnosis of dementia;
- with Apathy Evaluation Scale by (by informant/caregiver) (AES-I) score ≥36.
Key exclusion criteria (11 listed)
- acute medical conditions requiring hospitalization within the past month;
- diagnosis of neurological disorders other than dementia that interfere with apathy or functional assessment (e.g., Parkinson's disease);
- moderate to severe dementia (i.e., Functional Assessment Staging Tool (FAST) ≥6);
- receiving hospice care;
- severe vision or hearing deficits;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transcranial direct current stimulationtDCS 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. | Device | tDCS arm |
| sham stimulationsham 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. | Device | sham arm |
Primary outcome
Participant Retention Rate
Time frame: Up to 2 weeks (from the first stimulation session through the immediate post-intervention assessment)
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.
8 secondary outcomes
Blinding Efficacy
Time frame: Immediately after the first session of stimulation, and immediately after 5 sessions of stimulation
Side Effects
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
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
Time frame: Baseline and approximately Week 2 (within 3 days after the final stimulation session)
Change in PROMIS Depression Score
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
Time frame: Baseline and approximately Week 2 (within 3 days after the final stimulation session)
Change in Montreal Cognitive Assessment (MoCA) Score
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)
Time frame: Baseline and approximately Week 2 (within 3 days after the final stimulation session)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chan Mi Park, MD, MPH contact
Questions about this trial
What is this clinical trial studying?
A study testing transcranial direct current stimulation in people with Apathy and Brain Stimulation, run by Hebrew SeniorLife.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Junhong Zhou, PhD (6179715346, junhongzhou@hsl.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant Retention Rate (time frame: Up to 2 weeks (from the first stimulation session through the immediate post-intervention assessment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026; AzTrials last refreshed its copy on 28 Oct 2026.