Transcranial Direct Current StimulationHD-tDCSNCT04599764
High Definition Transcranial Direct Current Stimulation (HD-tDCS) for Early Alzheimer's Disease
A study testing HD-tDCS and computer-based cognitive training in people with Transcranial Direct Current Stimulation and Functional Magnetic Resonance Imaging, run by Anhui Medical University at 1 site in China.
Trial summary
This completed randomized trial evaluated the clinical and neural effects of high-definition transcranial direct current stimulation (HD-tDCS) combined with computerized cognitive training in patients with Alzheimer's disease. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Transcranial Direct Current Stimulation, Functional Magnetic Resonance Imaging, Early Alzheimer's Disease
- What is being tested?
- HD-tDCS and computer-based cognitive training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2020to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject diagnosed with early Alzheimer's disease or related diseases according to NINCDS-ACDRADA criteria.
- Subjects must have a MMSE score between 10 and 27,indicating mild cognitive impairment or dementia
- CDR score ≤ 2
- Subject under treatment by IAChE for at least 3 months.
- psychotropic treatments are tolerated if they were administered and unchanged for at least 3 months
Who cannot join
- CDR > 2
- Any history or clinical signs of other severe psychiatric illnesses (like major depression,psychosis or obsessive compulsive disorder).
- History of head injury,stroke,or other neurologic disease.
- Organic brain defects on T1 or T2 images.
- History of seizures or unexplained loss of consciousness.
- Implanted pacemaker,medication pump,vagal stimulator,deep brain stimulator.
- Family history of medication refractory epilepsy.
- History of substance abuse within the last 6 months.
Trial locations and contacts
1 site in 1 country.
About this study
This completed randomized trial evaluated the clinical and neural effects of high-definition transcranial direct current stimulation (HD-tDCS) combined with computerized cognitive training in patients with Alzheimer's disease. Participants were assigned to active HD-tDCS plus computerized cognitive training, computerized cognitive training control, or active HD-tDCS control. The study assessed whether combined neuromodulation and cognitive training produced greater cognitive and clinical benefit than either component condition, and whether treatment-related benefit was associated with changes in brain network organization.
Read the detailed description
Upon meeting the inclusion criteria and providing informed consent, each participant completed a series of cognitive, neuropsychological, and neuroimaging assessments at the hospital outpatient clinics or inpatient department before receiving the assigned intervention.
Participants were randomly allocated to one of three parallel intervention arms: active anodal high-definition transcranial direct current stimulation (HD-tDCS) combined with computerized cognitive training, active anodal HD-tDCS combined with control cognitive training, or sham HD-tDCS combined with computerized cognitive training. Approximately 20 participants were assigned to each group.
Participants were studied using a masked randomized design. Study participants and personnel responsible for clinical and neuropsychological outcome assessments remained masked to the assigned stimulation condition and allocation parameters. Only trained tDCS administrators had access to the randomization list; they had minimal contact with participants and had no role in cognitive or clinical assessments.
Each participant received the assigned intervention for 10 sessions over 2 weeks. Active HD-tDCS was delivered using an anodal stimulation protocol. In the combined intervention arm, active HD-tDCS was paired with computerized cognitive training. In the active HD-tDCS control arm, active stimulation was paired with control cognitive training. Control cognitive training consisted of structured computer-based cognitive activities matched for session duration, computer exposure, task instructions, and participant contact, but used fixed or minimally adaptive task difficulty and did not include individualized performance-based progression. In the sham stimulation arm, computerized cognitive training was paired with sham HD-tDCS.
Before intervention, trained investigators obtained baseline cognitive and neuropsychological assessments. The assessment battery included the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog), Montreal Cognitive Assessment (MoCA), associative memory measures, and additional tasks and questionnaires assessing general cognition, attention, executive function, language, memory, mood, and daily functioning. These measures included Digit Span, Stroop test, verbal fluency test, Symbol Digit Modalities Test, Auditory Verbal Learning Test, associative memory tasks, working memory tasks, Hamilton Anxiety Rating Scale, Hamilton Depression Rating Scale, and other executive-function tasks. Stimulation tolerability and adverse events were also assessed. The baseline assessment was completed over approximately 2 days.
Participants also underwent multimodal magnetic resonance imaging and electroencephalography recording to assess neural mechanisms related to the intervention. Follow-up evaluations were conducted after the intervention course, including clinical and neuropsychological assessments, stimulation tolerability assessment, and adverse-event monitoring. Post-intervention assessments, neuropsychological testing, multimodal MRI, and EEG recording were completed within 24 hours after the last stimulation session whenever feasible. Additional follow-up assessments were conducted approximately 1 month and 3 months after the last stimulation session using the same or comparable clinical and cognitive assessment battery. Participants were instructed to answer symptom and function questionnaires based on the relevant recent assessment period.
- Conditions
- Transcranial Direct Current Stimulation, Functional Magnetic Resonance Imaging, Early Alzheimer's Disease
- Being tested
- HD-tDCS, computer-based cognitive training, Sham tDCS, Control cognitive training
- Keywords
- High Definition Transcranial Direct Current Stimulation, Functional Magnetic Resonance Imaging, Neuropsychology, Early Alzheimer's Disease, Working Memory, Alzheimer's Disease Assessment Scale-Cognitive Subscale
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HD-tDCSOther
Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation tool that alters cortical excitability and activity via application of weak direct currents.HD-tDCS was administered using the Soterix 1×1 tDCS Low-Intensity Stimulator and the Soterix 4×1 Adapter. The selection of the electrode montage was based on computational models generating simulated current topography using HD Explore, which demonstrated good current distribution in the left dorsolateral prefrontal cortex (DLPFC). For left DLPFC stimulation, the anodal electrode was placed at the F3 position (using the International 10-20 EEG system), and the 4 return electrodes (cathodes) were placed at positions AFz, FCz, F7, and C5 (4-6 cm from the anode). The center position CZ was aligned with the vertex of the head. During anodal DLPFC stimulation, participants received stimulation at 2 mA for 30 minutes, including a 30-second ramp-up period at the start and a 30-second ramp-down period at the end.
computer-based cognitive trainingOther
Computer-based cognitive training (CCT) is a potentially important tool for individuals at risk of dementia. This trial will employ a computerized multi-domain adaptive training program. This program and training model have been demonstrated to be effective and beneficial in patients with vascular cognitive impairment. In the CCT intervention group, participants will undergo 2 weeks of computerized, multi-domain, adaptive training. The training domains include processing speed, attention, perception, long-term memory, working memory, calculation, executive control, reasoning, and problem-solving. Task rigor varies across domains and determines task grouping. Participants are required to complete 30 minutes of daily training(one session each of six 5-minute tasks).
Sham tDCSOther
Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation tool that alters cortical excitability and activity via application of weak direct currents.HD-tDCS was administered using the Soterix 1×1 tDCS Low-Intensity Stimulator and the Soterix 4×1 Adapter. The selection of the electrode montage was based on computational models generating simulated current topography using HD Explore, which demonstrated good current distribution in the left dorsolateral prefrontal cortex (DLPFC). For left DLPFC stimulation, the anodal electrode was placed at the F3 position (using the International 10-20 EEG system), and the 4 return electrodes (cathodes) were placed at positions AFz, FCz, F7, and C5 (4-6 cm from the anode). The center position CZ was aligned with the vertex of the head. For sham stimulation, participants received only the initial 30-second ramp-up to 2 mA, after which stimulation was immediately terminated.
Control cognitive trainingBehavioural
Control cognitive training consisted of a structured, computer-based cognitive activity matched to the adaptive computerized cognitive training program for session duration, screen exposure, task instructions, and participant contact. The control tasks used fixed or minimally adaptive task difficulty and did not provide individualized, performance-based progression. This condition was designed to control for nonspecific effects of computer use, task engagement, therapist contact, and repeated cognitive activity, while minimizing the adaptive cognitive-training component.
| Study group | Role | What they receive |
|---|---|---|
| Sham-Anode tDCS & Computerized cognitive training | Sham comparator | Participants will receive Computerized cognitive training+Sham tDCS daily for two weeks Receives: Other: computer-based cognitive training; Other: Sham tDCS |
| Anodal tDCS with Computerized cognitive training | Active comparator | Participants will receive anoale tDCS daily and Computerized cognitive training for two weeks Receives: Other: HD-tDCS; Other: computer-based cognitive training |
| Anodal tDCS with Control Cognitive training | Active comparator | Participants will receive anoale tDCS daily with control cognitive training for two weeks Receives: Other: HD-tDCS; Behavioral: Control cognitive training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes assessed by Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog)
This is an very common clinical motor estimating scale. including orientation, language, structure, application of concepts, immediate recall of words and recognition of words, with a full score of 70. Higher scores indicate worse symptoms.
Measured: changes from baseline at 14 days and 12 weeks post-treatment
Secondary outcomes (4)
special-version working memory
the accuracy and reaction time in working memory task
Measured: changes from baseline at 14 days and 4,12 weeks post-treatment
Associative Memory
The changes in Associative Memory will constitute the major research outcome measure used to assess response to HD-tDCS.
Measured: changes from baseline at 14 days and 4,12 weeks post-treatment
MMSE(Mini Mental State Examination)
The full name of MMSE is mini-mental state examination, and the scale consists of 30 subject, include the following seven aspects: time orientation, place orientation,immediate memory,attention and calculation,delay memory,language, visual space.One point is awarded for each question correctly answered during MMSE evaluation. If subject give the wrong answer or don't know answe he/she awarded 0 score, scope of scale score of 0 to 30 points. The higher the score, the better.
Measured: changes from baseline at 14 days and 4,12 weeks post-treatment
LMT (Logic Memory Test)
The changes in LMT will constitute the secondary research outcome
Measured: changes from baseline at 7,14 days and 4,12 weeks post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2020
- Study start1 Dec 2020
- Primary completion1 Dec 2025
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transcranial Direct Current StimulationStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anhui Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, WANG KAI, Anhui Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04599764
- Sponsor's protocol ID
- AH med university2018913
- Acronym
- HD-tDCS
- Status last verified
- Oct 2026
- First submitted
- 18 Oct 2020
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Contact us by email with intent to use and decide whether to share data
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Definition Transcranial Direct Current Stimulation (HD-tDCS) for Early Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT04599764
- Acronym / sponsor ID
- HD-tDCS / AH med university2018913
- Conditions
- Transcranial Direct Current Stimulation, Functional Magnetic Resonance Imaging, Early Alzheimer's Disease
- Keywords
- High Definition Transcranial Direct Current Stimulation, Functional Magnetic Resonance Imaging, Neuropsychology, Early Alzheimer's Disease, Working Memory, Alzheimer's Disease Assessment Scale-Cognitive Subscale
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Anhui Medical UniversityUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 23 Oct 2020 (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.
This completed randomized trial evaluated the clinical and neural effects of high-definition transcranial direct current stimulation (HD-tDCS) combined with computerized cognitive training in patients with Alzheimer's disease. Participants were assigned to active HD-tDCS plus computerized cognitive training, computerized cognitive training control, or active HD-tDCS control. The study assessed whether combined neuromodulation and cognitive training produced greater cognitive and clinical benefit than either component condition, and whether treatment-related benefit was associated with changes in brain network organization.
Detailed description
Upon meeting the inclusion criteria and providing informed consent, each participant completed a series of cognitive, neuropsychological, and neuroimaging assessments at the hospital outpatient clinics or inpatient department before receiving the assigned intervention.
Participants were randomly allocated to one of three parallel intervention arms: active anodal high-definition transcranial direct current stimulation (HD-tDCS) combined with computerized cognitive training, active anodal HD-tDCS combined with control cognitive training, or sham HD-tDCS combined with computerized cognitive training. Approximately 20 participants were assigned to each group.
Participants were studied using a masked randomized design. Study participants and personnel responsible for clinical and neuropsychological outcome assessments remained masked to the assigned stimulation condition and allocation parameters. Only trained tDCS administrators had access to the randomization list; they had minimal contact with participants and had no role in cognitive or clinical assessments.
Each participant received the assigned intervention for 10 sessions over 2 weeks. Active HD-tDCS was delivered using an anodal stimulation protocol. In the combined intervention arm, active HD-tDCS was paired with computerized cognitive training. In the active HD-tDCS control arm, active stimulation was paired with control cognitive training. Control cognitive training consisted of structured computer-based cognitive activities matched for session duration, computer exposure, task instructions, and participant contact, but used fixed or minimally adaptive task difficulty and did not include individualized performance-based progression. In the sham stimulation arm, computerized cognitive training was paired with sham HD-tDCS.
Before intervention, trained investigators obtained baseline cognitive and neuropsychological assessments. The assessment battery included the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog), Montreal Cognitive Assessment (MoCA), associative memory measures, and additional tasks and questionnaires assessing general cognition, attention, executive function, language, memory, mood, and daily functioning. These measures included Digit Span, Stroop test, verbal fluency test, Symbol Digit Modalities Test, Auditory Verbal Learning Test, associative memory tasks, working memory tasks, Hamilton Anxiety Rating Scale, Hamilton Depression Rating Scale, and other executive-function tasks. Stimulation tolerability and adverse events were also assessed. The baseline assessment was completed over approximately 2 days.
Participants also underwent multimodal magnetic resonance imaging and electroencephalography recording to assess neural mechanisms related to the intervention. Follow-up evaluations were conducted after the intervention course, including clinical and neuropsychological assessments, stimulation tolerability assessment, and adverse-event monitoring. Post-intervention assessments, neuropsychological testing, multimodal MRI, and EEG recording were completed within 24 hours after the last stimulation session whenever feasible. Additional follow-up assessments were conducted approximately 1 month and 3 months after the last stimulation session using the same or comparable clinical and cognitive assessment battery. Participants were instructed to answer symptom and function questionnaires based on the relevant recent assessment period.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sham-Anode tDCS & Computerized cognitive training | Sham comparator | Other: computer-based cognitive training, Other: Sham tDCSParticipants will receive Computerized cognitive training+Sham tDCS daily for two weeks |
| Anodal tDCS with Computerized cognitive training | Active comparator | Other: HD-tDCS, Other: computer-based cognitive trainingParticipants will receive anoale tDCS daily and Computerized cognitive training for two weeks |
| Anodal tDCS with Control Cognitive training | Active comparator | Other: HD-tDCS, Behavioral: Control cognitive trainingParticipants will receive anoale tDCS daily with control cognitive training for two weeks |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subject diagnosed with early Alzheimer's disease or related diseases according to NINCDS-ACDRADA criteria.
- Subjects must have a MMSE score between 10 and 27,indicating mild cognitive impairment or dementia
- CDR score ≤ 2
- Subject under treatment by IAChE for at least 3 months.
- psychotropic treatments are tolerated if they were administered and unchanged for at least 3 months
Key exclusion criteria (8 listed)
- CDR > 2
- Any history or clinical signs of other severe psychiatric illnesses (like major depression,psychosis or obsessive compulsive disorder).
- History of head injury,stroke,or other neurologic disease.
- Organic brain defects on T1 or T2 images.
- History of seizures or unexplained loss of consciousness.
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 |
|---|---|---|
| HD-tDCSTranscranial direct current stimulation (tDCS) is a non-invasive brain stimulation tool that alters cortical excitability and activity via application of weak direct currents.HD-tDCS was administered using the Soterix 1×1 tDCS Low-Intensity Stimulator and the Soterix 4×1 Adapter. The selection of the electrode montage was based on computational models generating simulated current topography using HD Explore, which demonstrated good current distribution in the left dorsolateral prefrontal cortex (DLPFC). For left DLPFC stimulation, the anodal electrode was placed at the F3 position (using the International 10-20 EEG system), and the 4 return electrodes (cathodes) were placed at positions AFz, FCz, F7, and C5 (4-6 cm from the anode). The center position CZ was aligned with the vertex of the head. During anodal DLPFC stimulation, participants received stimulation at 2 mA for 30 minutes, including a 30-second ramp-up period at the start and a 30-second ramp-down period at the end. | Other | Anodal tDCS with Computerized cognitive training, Anodal tDCS with Control Cognitive training |
| computer-based cognitive trainingComputer-based cognitive training (CCT) is a potentially important tool for individuals at risk of dementia. This trial will employ a computerized multi-domain adaptive training program. This program and training model have been demonstrated to be effective and beneficial in patients with vascular cognitive impairment. In the CCT intervention group, participants will undergo 2 weeks of computerized, multi-domain, adaptive training. The training domains include processing speed, attention, perception, long-term memory, working memory, calculation, executive control, reasoning, and problem-solving. Task rigor varies across domains and determines task grouping. Participants are required to complete 30 minutes of daily training(one session each of six 5-minute tasks). | Other | Anodal tDCS with Computerized cognitive training, Sham-Anode tDCS & Computerized cognitive training |
| Sham tDCSTranscranial direct current stimulation (tDCS) is a non-invasive brain stimulation tool that alters cortical excitability and activity via application of weak direct currents.HD-tDCS was administered using the Soterix 1×1 tDCS Low-Intensity Stimulator and the Soterix 4×1 Adapter. The selection of the electrode montage was based on computational models generating simulated current topography using HD Explore, which demonstrated good current distribution in the left dorsolateral prefrontal cortex (DLPFC). For left DLPFC stimulation, the anodal electrode was placed at the F3 position (using the International 10-20 EEG system), and the 4 return electrodes (cathodes) were placed at positions AFz, FCz, F7, and C5 (4-6 cm from the anode). The center position CZ was aligned with the vertex of the head. For sham stimulation, participants received only the initial 30-second ramp-up to 2 mA, after which stimulation was immediately terminated. | Other | Sham-Anode tDCS & Computerized cognitive training |
| Control cognitive trainingControl cognitive training consisted of a structured, computer-based cognitive activity matched to the adaptive computerized cognitive training program for session duration, screen exposure, task instructions, and participant contact. The control tasks used fixed or minimally adaptive task difficulty and did not provide individualized, performance-based progression. This condition was designed to control for nonspecific effects of computer use, task engagement, therapist contact, and repeated cognitive activity, while minimizing the adaptive cognitive-training component. | Behavioural | Anodal tDCS with Control Cognitive training |
Primary outcome
Changes assessed by Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog)
Time frame: changes from baseline at 14 days and 12 weeks post-treatment
This is an very common clinical motor estimating scale. including orientation, language, structure, application of concepts, immediate recall of words and recognition of words, with a full score of 70. Higher scores indicate worse symptoms.
4 secondary outcomes
special-version working memory
Time frame: changes from baseline at 14 days and 4,12 weeks post-treatment
Associative Memory
Time frame: changes from baseline at 14 days and 4,12 weeks post-treatment
MMSE(Mini Mental State Examination)
Time frame: changes from baseline at 14 days and 4,12 weeks post-treatment
LMT (Logic Memory Test)
Time frame: changes from baseline at 7,14 days and 4,12 weeks post-treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Individual participant dataSharing planned: Undecided. Contact us by email with intent to use and decide whether to share data
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HD-tDCS and computer-based cognitive training in people with Transcranial Direct Current Stimulation and Functional Magnetic Resonance Imaging, run by Anhui Medical University at 1 site in China.
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 5 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: finished, as of the sponsor's last update on 7 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 China. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Changes assessed by Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) (time frame: changes from baseline at 14 days and 12 weeks post-treatment). 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 7 Oct 2026.