Mild Cognitive ImpairmentNCT05978804
Home-based tDCS in Frontotemporal Dementia or Alzheimer's Disease
A study testing Computerized Cognitive Training and Active tDCS (tDCS) on DLPFC in people with Mild Cognitive Impairment and Primary Progressive Aphasia, run by Johns Hopkins University at 1 site in United States.
Trial summary
The primary objective of this research is to evaluate the effects of non-invasive brain stimulation and computerized cognitive training on executive functioning in individuals with Primary Progressive Aphasia (PPA), mild cognitive impairment (MCI), or dementia. Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Mild Cognitive Impairment, Primary Progressive Aphasia, Dementia
- What is being tested?
- Computerized Cognitive Training and Active tDCS (tDCS) on DLPFC
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Aug 2023to 10 Sep 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must be clinically diagnosed with PPA, fronto-temporal dementia (FTD), MCI or mild Alzheimer's disease (AD). Diagnosis will be based on neuropsychological testing, language testing (most commonly the Western Aphasia Battery), MRI, and clinical assessment.
- Must be right-handed.
- Must be proficient in English.
- Must have a minimum high-school education.
Who cannot join
- Uncorrected visual or hearing impairment by self-report.
- Stroke/other premorbid neurological disorder affecting the brain.
- Any other developmental language-based learning disorder other than PPA.
- Inability to follow directions for baseline tasks.
- Pre-existing psychiatric disorders such as behavioral disturbances, severe depression, and schizophrenia that do not allow them to comply or follow the study schedule and requirements such as repeated evaluation and therapy will be excluded.
- Severe claustrophobia.
- Cardiac pacemakers or ferromagnetic implants.
- Pregnant women.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Remote Home-based Electrical Stimulation (tDCS) in Primary Progressive Aphasia (With Frontotemporal Dementia or Alzheimer's Pathology) and Mild Cognitive Impairment/Alzheimer's.
The primary objective of this research is to evaluate the effects of non-invasive brain stimulation and computerized cognitive training on executive functioning in individuals with Primary Progressive Aphasia (PPA), mild cognitive impairment (MCI), or dementia. In this study, investigators will use transcranial direct current stimulation (tDCS) to stimulate the left dorsolateral prefrontal cortex (DLPFC). Previous studies have demonstrated that tDCS over the DLPFC led to improvements in attention deficit caused by stroke, Parkinson's Disease, and major depression as well as language deficits caused by neurodegenerative conditions such as primary progressive aphasia or mild cognitive impairment. The investigators seek to expand on this literature by investigating how anodal tDCS paired with and without cognitive training will impact executive functioning in PPA with Frontotemporal Dementia or Alzheimer's Disease pathology and Mild Cognitive Impairment/Alzheimer's Disease (e.g. shifting, updating, monitoring, and manipulation).
Read the detailed description
In this within-subject cross-over protocol, all participants will receive both, cognitive training and brain stimulation tDCS. Participants will be randomly assigned to begin with either cognitive training and brain stimulation (dual therapy) or just brain stimulation (monotherapy) and will receive the complementary therapy program in the second round of treatment. During each period of therapy, participants will receive 50 treatment sessions over the course of approximately 10 weeks. The computerized cognitive training and brain stimulation will both be preprogrammed to be done at home by the participant.
- Being tested
- Computerized Cognitive Training, Active tDCS (tDCS) on DLPFC
- Medical subject headings
- Cognitive Dysfunction, Aphasia, Primary Progressive, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computerized Cognitive TrainingOther
Computerized Cognitive training (BrainHQ or Constant Therapy)
Active tDCS (tDCS) on DLPFCDevice
Device: Active tDCS on DLPFC Stimulation will be delivered by a constant current stimulator (Mind STIM). The electrical current will be administered to a pre-specified region of the brain (DLPFC). The stimulation will be delivered at an intensity of 2 milliamperes (mA) (estimated current density 0.04 mA/cm2; estimated total charge 0.048 Coulombs/cm2) in a ramp-like fashion for a maximum of 20 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Active tDCS on the DLPFC + Cognitive Intervention(s) | Experimental | Participants will receive active tDCS on DLPFC + Cognitive Intervention(s) first and then receive only active tDCS Intervention after a three-month washout period. Receives: Other: Computerized Cognitive Training; Device: Active tDCS (tDCS) on DLPFC |
| Active tDCS on the DLPFC only | Experimental | Participants will receive active tDCS on the DLPFC-only intervention first and then receive active tDCS + Cognitive Intervention(s) after a three-month washout period. Receives: Device: Active tDCS (tDCS) on DLPFC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Language Composite Outcome
A single language composite outcome will be generated by computing the mean of the percentage accuracy of the following naming, spelling, and sentence comprehension and repetition tasks: Boston Naming Test, Hopkins Action Naming Assessment, National Alzheimer's Coordinating Center Sentence Repetition. The investigators will calculate the percentage accuracy for each task and average them in order to get a composite score.
Measured: Up to 6 weeks before intervention (before Phase 1) up to 1 week post-intervention (after Phase 1). Phase 1 intervention lasted 10 weeks.
Change in Executive Composite Outcome
A single executive composite will be generated by computing the mean of the percentage accuracy of the tasks below reflecting new learning and memory, processing speed and executive functioning, attention and working memory, and verbal fluency respectively: Rey Auditory Verbal Learning Test, Digit Span, Category Fluency, and Verbal Fluency. The investigators will calculate the percentage accuracy for each task and average them in order to get a composite score.
Measured: Up to 6 weeks before intervention (before Phase 1) up to 1 week post-intervention (after Phase 1). Phase 1 intervention lasted 10 weeks.
Change in Global Cognitive Scores
This will be measured using the Montreal Cognitive Assessment (MoCA). Score range 0-30 points, higher is better.
Measured: Up to 6 weeks before intervention (before Phase 1) up to 1 week post-intervention (after Phase 1). Phase 1 intervention lasted 10 weeks.
Secondary outcomes (1)
Change in Working Memory Capacity.
This will be measured using Digit Span Backward for verbal working memory. The digit span backward is a well-established task that assesses rote immediate verbal memory and working memory. Participants are presented with a series of digits and are instructed to repeat the digits in the reverse order. Scoring is based on the number of digits shown in a trial (i.e. 1,7 is 2 digits). There are two trials for each span, and if both trials are correct, the score is a whole number (i.e. 2). If one trial is incorrect in a span, subtract 0.5 from that tier (i.e. 1.5). Increase in score from before to after intervention is considered a benefit. The range of the score is from 0 to 8, with 0 being the lowest/worst score and 8 being the highest/best score possible.
Measured: Up to 6 weeks before intervention (before Phase 1) up to 1 week post-intervention (after Phase 1). Phase 1 intervention lasted 10 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2023
- Study start10 Aug 2023
- Primary completion10 Sep 2025
- Study completion10 Sep 2025
Why it stopped: Lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Crossover
- Model description
- Subjects meeting eligibility criteria will be randomized to receive either tDCS + cognitive training or only tDCS. After 50 treatment sessions (approximately 10 weeks) participants will switch to the other condition.
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Ybrain Inc.
- Responsible party
- Sponsor
- Investigators
- Kyrana Tsapkini, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05978804
- Sponsor's protocol ID
- NA_00071337-4
- Status last verified
- Sep 2026
- First submitted
- 11 Jul 2023
- Last updated
- 21 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Home-based Electrical Stimulation (tDCS) in Primary Progressive Aphasia (With Frontotemporal Dementia or Alzheimer's Pathology) and Mild Cognitive Impairment/Alzheimer's.
- ClinicalTrials.gov ID
- NCT05978804
- Acronym / sponsor ID
- NA_00071337-4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of funding
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Ybrain Inc.
- Study start
- 10 Aug 2023 (actual)
- Primary completion
- 10 Sep 2025 (actual)
- Study completion
- 10 Sep 2025 (actual)
- First posted
- 7 Aug 2023 (actual)
- Results
- Posted 21 Oct 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this research is to evaluate the effects of non-invasive brain stimulation and computerized cognitive training on executive functioning in individuals with Primary Progressive Aphasia (PPA), mild cognitive impairment (MCI), or dementia. In this study, investigators will use transcranial direct current stimulation (tDCS) to stimulate the left dorsolateral prefrontal cortex (DLPFC). Previous studies have demonstrated that tDCS over the DLPFC led to improvements in attention deficit caused by stroke, Parkinson's Disease, and major depression as well as language deficits caused by neurodegenerative conditions such as primary progressive aphasia or mild cognitive impairment. The investigators seek to expand on this literature by investigating how anodal tDCS paired with and without cognitive training will impact executive functioning in PPA with Frontotemporal Dementia or Alzheimer's Disease pathology and Mild Cognitive Impairment/Alzheimer's Disease (e.g. shifting, updating, monitoring, and manipulation).
Detailed description
In this within-subject cross-over protocol, all participants will receive both, cognitive training and brain stimulation tDCS. Participants will be randomly assigned to begin with either cognitive training and brain stimulation (dual therapy) or just brain stimulation (monotherapy) and will receive the complementary therapy program in the second round of treatment. During each period of therapy, participants will receive 50 treatment sessions over the course of approximately 10 weeks. The computerized cognitive training and brain stimulation will both be preprogrammed to be done at home by the participant.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Subjects meeting eligibility criteria will be randomized to receive either tDCS + cognitive training or only tDCS. After 50 treatment sessions (approximately 10 weeks) participants will switch to the other condition.
| Arm | Type | Receives |
|---|---|---|
| Active tDCS on the DLPFC + Cognitive Intervention(s) | Experimental | Other: Computerized Cognitive Training, Device: Active tDCS (tDCS) on DLPFCParticipants will receive active tDCS on DLPFC + Cognitive Intervention(s) first and then receive only active tDCS Intervention after a three-month washout period. |
| Active tDCS on the DLPFC only | Experimental | Device: Active tDCS (tDCS) on DLPFCParticipants will receive active tDCS on the DLPFC-only intervention first and then receive active tDCS + Cognitive Intervention(s) after a three-month washout period. |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Must be clinically diagnosed with PPA, fronto-temporal dementia (FTD), MCI or mild Alzheimer's disease (AD). Diagnosis will be based on neuropsychological testing, language testing (most commonly the Western Aphasia Battery), MRI, and clinical assessment.
- Must be right-handed.
- Must be proficient in English.
- Must have a minimum high-school education.
Key exclusion criteria (8 listed)
- Uncorrected visual or hearing impairment by self-report.
- Stroke/other premorbid neurological disorder affecting the brain.
- Any other developmental language-based learning disorder other than PPA.
- Inability to follow directions for baseline tasks.
- Pre-existing psychiatric disorders such as behavioral disturbances, severe depression, and schizophrenia that do not allow them to comply or follow the study schedule and requirements such as repeated evaluation and therapy will be excluded.
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 |
|---|---|---|
| Computerized Cognitive TrainingComputerized Cognitive training (BrainHQ or Constant Therapy) | Other | Active tDCS on the DLPFC + Cognitive Intervention(s) |
| Active tDCS (tDCS) on DLPFCDevice: Active tDCS on DLPFC Stimulation will be delivered by a constant current stimulator (Mind STIM). The electrical current will be administered to a pre-specified region of the brain (DLPFC). The stimulation will be delivered at an intensity of 2 milliamperes (mA) (estimated current density 0.04 mA/cm2; estimated total charge 0.048 Coulombs/cm2) in a ramp-like fashion for a maximum of 20 minutes. | Device | Active tDCS on the DLPFC + Cognitive Intervention(s), Active tDCS on the DLPFC only |
Primary outcome
Change in Language Composite Outcome
Time frame: Up to 6 weeks before intervention (before Phase 1) up to 1 week post-intervention (after Phase 1). Phase 1 intervention lasted 10 weeks.
A single language composite outcome will be generated by computing the mean of the percentage accuracy of the following naming, spelling, and sentence comprehension and repetition tasks: Boston Naming Test, Hopkins Action Naming Assessment, National Alzheimer's Coordinating Center Sentence Repetition. The investigators will calculate the percentage accuracy for each task and average them in order to get a composite score.
Change in Executive Composite Outcome
Time frame: Up to 6 weeks before intervention (before Phase 1) up to 1 week post-intervention (after Phase 1). Phase 1 intervention lasted 10 weeks.
A single executive composite will be generated by computing the mean of the percentage accuracy of the tasks below reflecting new learning and memory, processing speed and executive functioning, attention and working memory, and verbal fluency respectively: Rey Auditory Verbal Learning Test, Digit Span, Category Fluency, and Verbal Fluency. The investigators will calculate the percentage accuracy for each task and average them in order to get a composite score.
Change in Global Cognitive Scores
Time frame: Up to 6 weeks before intervention (before Phase 1) up to 1 week post-intervention (after Phase 1). Phase 1 intervention lasted 10 weeks.
This will be measured using the Montreal Cognitive Assessment (MoCA). Score range 0-30 points, higher is better.
1 secondary outcome
Change in Working Memory Capacity.
Time frame: Up to 6 weeks before intervention (before Phase 1) up to 1 week post-intervention (after Phase 1). Phase 1 intervention lasted 10 weeks.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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. This study is not recruiting at the moment.
Kyrana Tsapkini, PhD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computerized Cognitive Training and Active tDCS (tDCS) on DLPFC in people with Mild Cognitive Impairment and Primary Progressive Aphasia, run by Johns Hopkins University at 1 site in United States.
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 8 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: stopped early, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Yes. Results are posted in the registry (first posted 21 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Language Composite Outcome (time frame: Up to 6 weeks before intervention (before Phase 1) up to 1 week post-intervention (after Phase 1). Phase 1 intervention lasted 10 weeks.). The study lists 3 primary outcomes in all. 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 21 Oct 2026.