High Definition Transcranial Direct Current Stimulation (HD-tDCS) for Early Alzheimer's Disease
HD-tDCS
1 other identifier
interventional
60
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2020
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2020
CompletedFirst Submitted
Initial submission to the registry
October 18, 2020
CompletedFirst Posted
Study publicly available on registry
October 23, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2025
CompletedJune 11, 2026
June 1, 2026
5.5 years
October 18, 2020
June 9, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
changes from baseline at 14 days and 12 weeks post-treatment
Secondary Outcomes (4)
special-version working memory
changes from baseline at 14 days and 4,12 weeks post-treatment
Associative Memory
changes from baseline at 14 days and 4,12 weeks post-treatment
MMSE(Mini Mental State Examination)
changes from baseline at 14 days and 4,12 weeks post-treatment
LMT (Logic Memory Test)
changes from baseline at 7,14 days and 4,12 weeks post-treatment
Other Outcomes (11)
DST (Digital Span Test; Forward and Backward)
changes from baseline at 14 days and 4,12 weeks post-treatment
TMT (Trail Making Test)
changes from baseline at 14 days and 4,12 weeks post-treatment
HAMD (Hamilton Depression Scale)
changes from baseline at 14 days and 4,12 weeks post-treatment
- +8 more other outcomes
Study Arms (3)
Sham-Anode tDCS & Computerized cognitive training
SHAM COMPARATORParticipants will receive Computerized cognitive training+Sham tDCS daily for two weeks
Anodal tDCS with Computerized cognitive training
ACTIVE COMPARATORParticipants will receive anoale tDCS daily and Computerized cognitive training for two weeks
Anodal tDCS with Control Cognitive training
ACTIVE COMPARATORParticipants will receive anoale tDCS daily with control cognitive training for two weeks
Interventions
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 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).
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 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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Anhui Medical University
Hefei, Anhui, 230032, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Caregivers, subjects, and evaluators remain blind
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of medical psychological department, Anhui Medical University
Study Record Dates
First Submitted
October 18, 2020
First Posted
October 23, 2020
Study Start
June 1, 2020
Primary Completion
December 1, 2025
Study Completion
December 1, 2025
Last Updated
June 11, 2026
Record last verified: 2026-06