Mild Cognitive ImpairmentNCT04121156
High Definition Transcranial Direct Current Stimulation (HD-tDCS) in Patients With Mild Cognitive Impairment
A study testing HD-tDCS treatment in people with Mild Cognitive Impairment, run by Kaohsiung Veterans General Hospital. at 1 site in Taiwan.
Trial summary
The study aimed to investigate whether high definition transcranial direct current stimulation (HD-tDCS) could benefit global cognitive function and sub-domains of cognition (visual/verbal/working memory, executive function, attention, processing speed, language, and frontal lobe function), mood (depression and… Read more about this study
- Who is it for?
- Ages 65 to 85 years
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- HD-tDCS treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteTaiwan
- Study dates
- 30 Sep 2020to 31 Aug 2024
- 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 65 to 85 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Aged 65 to 85 years
- mild cognitive impairment
- right handed
Who cannot join
- Having epilepsy, severe physical illness, any current psychiatric comorbidity or history of substance dependence
- Having contraindications for transcranial electrical/magnetic stimulation.
- Having intracranial metal foreign bodies
- Having a history of intracranial neoplasms or surgery, or a history of severe head injuries or cerebrovascular diseases
- Receiving psychotropic agents such as antipsychotic, antidepressant, benzodiazepam and anxiolytics etc.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of High Definition Transcranial Direct Current Stimulation (HD-tDCS) on Cognitive Function in Patients With Mild Cognitive Impairment: a Randomized, Triple-blind, Sham-controlled, Pilot Study
The study aimed to investigate whether high definition transcranial direct current stimulation (HD-tDCS) could benefit global cognitive function and sub-domains of cognition (visual/verbal/working memory, executive function, attention, processing speed, language, and frontal lobe function), mood (depression and anxiety), and subjective memory impairment in patients with mild cognitive impairment.
Read the detailed description
Transcranial direct current stimulation (tDCS), a novel, non-invasive and safe neuro-modulating technique, has been developed as a new therapeutic option for neuropsychiatric disorders. It encompasses the induction of a relatively weak constant current flow through the cerebral cortex via scalp electrodes. Dependent on stimulation polarity, this results in a modulation of cortical excitability and spontaneous neural activity. Compared with tDCS, high-definition transcranial direct current stimulation (HD-tDCS) is highly focal and can specifically modulate cortical activity within the region confined by its 4 x 1 ring of elctrodes, such that the targeted region becomes more amenable to neuroplastic change. Studies have suggested that tDCS improve cognition, including memory recall, verbal fluency and executive function. Yet, there is not HD-tDCS study on MCI. The purpose of this study is to examine whether HD-tDCS could benefit global cognitive function and sub-domains of cognition (visual/verbal/working memory, executive function, attention, processing speed, language, and frontal lobe function), mood (depression and anxiety), and subjective memory impairment in patients with mild cognitive impairment.
- Conditions
- Mild Cognitive Impairment
- Being tested
- HD-tDCS treatment, sham (placebo) HD-tDCS
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HD-tDCS treatmentDevice
2 milli Amp dose of HD-tDCS treatment for for 20 minutes, for 5 consecutive twice daily sessions
sham (placebo) HD-tDCSDevice
Participants will receive sham (placebo) HD-tDCS for 20 minutes, for 5 consecutive twice daily sessions
| Study group | Role | What they receive |
|---|---|---|
| 2 milli Amp dose of HD-tDCS treatment | Active comparator | 2 milli Amp dose of HD-tDCS treatment for for 25 minutes, once working day for 2 weeks, total 10 sessions Receives: Device: HD-tDCS treatment |
| Sham (placebo) dose of HD-tDCS treatment | Sham comparator | Sham (placebo) dose of HD-tDCS treatment for 25 minutes, once working day for 2 weeks, total 10 sessions Receives: Device: sham (placebo) HD-tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive Abilities Screening Instrument, CASI
The Cognitive Abilities Screening Instrument (CASI) is a cognitive test screening for dementia, in monitoring the disease progression, and in providing profiles of cognitive impairment by examining abilities on attention, concentration, orientation, short-term memory, long-term memory, language abilities, visual construction, list-generating fluency, abstraction, and judgment with score ranges of 0 to 100, respectively.
Measured: Change from baseline after one week, one and three months
Wechsler Memory Scale-third edition (WMS III) - verbal paired associates I and II
For assessing verbal memory by assessing recall memory for orally presented word pairs that have been previously learned (verbal paired associates I); assessing ability to recall associations from Verbal Paired Associates I after a 30-minute delay, as well as assessing recognition of word pairs (verbal paired associates II).
Measured: Change from baseline after one week, one and three months
Wechsler Memory Scale-third edition (WMS III) - visual reproduction I and II
For assessing visual memory function by assessing ability to reproduce difficult-to-verbalize designs after a brief exposure (visual reproduction I); assessing ability to recall the designs presented in Visual Reproduction I after a 30-minute delay, as well as specific sub-subtests to assess recognition of correct figures from nontarget figures, copying of figures to assess visual perception abilities, and a subtest to analyze discrimination abilities (visual reproduction II).
Measured: Change from baseline after one week, one and three months
Wisconsin card sorting test
for assessing executive function
Measured: Change from baseline after one week, one and three months
Frontal assessment battery, FAB
The FAB is a brief tool that can be used at the bedside or in a clinic setting to assist frontal function of subjects. Total score is from a maximum of 18, higher scores indicating better performance. The scales consist similarities (conceptualization), lexical fluency (mental flexibility), motor series "Luria" test (programming), conflicting instructions (sensitivity to interference), Go-No Go (inhibitory control), prehension behaviour (environmental autonomy).
Measured: Change from baseline after one week, one and three months
Wechsler adult intelligence scale four edition, WAIS-IV, digit span
The Wechsler Adult Intelligence Scale (WAIS) is an IQ test designed to measure intelligence and cognitive ability in adults and older adolescents. It is currently in its fourth edition (WAIS-IV) released in 2008 by Pearson, and is the most widely used IQ test, for both adults and older adolescents, in the world.
We used WAIS-IV, digit span subscale, to examine attention among subjects; Digit span was by listening to sequences of numbers orally and to repeat them as heard, in reverse order, and in ascending order.
Measured: Change from baseline after one week, one and three months
Wechsler adult intelligence scale four edition, WAIS-IV, digit symbol coding
We used WAIS-IV, digit symbol coding subscale, to examine processing speed among subjects; The digit symbol coding is a paper-and-pencil cognitive test presented on a single sheet of paper that requires a subject to match symbols to numbers according to a key located on the top of the page. The subject copies the symbol into spaces below a row of numbers. The number of correct symbols within the allowed time, usually 90 to 120 seconds, constitutes the score
Measured: Change from baseline after one week, one and three months
Wechsler adult intelligence scale four edition, WAIS-IV, vocabulary
We used WAIS-IV, vocabulary subscale, to examine language function among subjects; The vocabulary subtest requires the client to try to define up to 30 words. This subtest assesses the client's understanding of words and reflects: language development, expressive language skills, cultural and educational experiences, ability to use words appropriately, retrieval of information from long-term memory.
Measured: Change from baseline after one week, one and three months
Secondary outcomes (3)
Beck depression inventory (BDI-II)
The BDI-II was a 1996 revision of the BDI. Participants were asked to rate how they have been feeling for the past two weeks. BDI-II also contains 21 questions, each answer being scored on a scale value of 0 to 3. Higher total scores indicate more severe depressive symptoms. The standardized cutoffs used as follows: 0-13: minimal depression; 14-19: mild depression; 20-28: moderate depression; 29-63: severe depression.
Measured: Change from baseline after one week, one and three months
Beck anxiety inventory (BAI)
The Beck Anxiety Inventory (BAI), created by Aaron T. Beck and other colleagues, is a 21-question multiple-choice self-report inventory that is used for measuring the severity of anxiety in children and adults. The BAI contains 21 questions, each answer being scored on a scale value of 0 (not at all) to 3 (severely). Higher total scores indicate more severe anxiety symptoms. The standardized cutoffs are as follows: 0-7: minimal anxiety; 8-15: mild anxiety; 16-25: moderate anxiety; 26-63: severe anxiety.
Measured: Change from baseline after one week, one and three months
Subjective Cognitive Decline Questionnaire (SCD-Q MyCog)
The SCD-Q is a validated questionnaire that assesses the presence of a subjective cognitive decay in abilities such as memory, attention, language or executive functions. This scale is made up of two parts: MyCog is filled by the subject, TheirCog by the caregiver. Both parts have 24 identical dichotomous questions (yes/no), that evaluate decline for memory performances, language and executive functions in the last 2 years of daily life. The SCD-Q score for MyCog and TheirCog ranges from 0 to 24, with higher scores associated with greater perceived cognitive changes (cut to be classified as SCD = 7).
Measured: Change from baseline after one week, one and three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2019
- Study start30 Sep 2020
- Primary completion31 Aug 2024
- Study completion31 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mild Cognitive ImpairmentStudies 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaohsiung Veterans General Hospital.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Che-Sheng Chu, Kaohsiung Veterans General Hospital.
- Investigators
- Che-Sheng Chu, MD, Principal investigator, Kaohsiung Veterans General Hospital.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04121156
- Sponsor's protocol ID
- VGHKS-2068
- Status last verified
- Oct 2024
- First submitted
- 8 Oct 2019
- Last updated
- 31 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chu CS, Chang HA, Lin YT, Shen HC, Liang CK, Hsu YH, Pan CC, Kuo HY, Liang WZ, Chen SL, Chen CS. Effectiveness and safety of high-definition transcranial direct current stimulation in patients with mild cognitive impairment: A randomized, triple-blind, sham-controlled trial. J Alzheimers Dis. 2025 Nov;108(1):298-311. doi: 10.1177/13872877251376547. Epub 2025 Sep 22.
PubMed 40984052
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of High Definition Transcranial Direct Current Stimulation (HD-tDCS) on Cognitive Function in Patients With Mild Cognitive Impairment: a Randomized, Triple-blind, Sham-controlled, Pilot Study
- ClinicalTrials.gov ID
- NCT04121156
- Acronym / sponsor ID
- VGHKS-2068
- Conditions
- Mild Cognitive Impairment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Kaohsiung Veterans General Hospital.University, hospital or other
- Study start
- 30 Sep 2020 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 31 Aug 2024 (actual)
- First posted
- 9 Oct 2019 (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.
The study aimed to investigate whether high definition transcranial direct current stimulation (HD-tDCS) could benefit global cognitive function and sub-domains of cognition (visual/verbal/working memory, executive function, attention, processing speed, language, and frontal lobe function), mood (depression and anxiety), and subjective memory impairment in patients with mild cognitive impairment.
Detailed description
Transcranial direct current stimulation (tDCS), a novel, non-invasive and safe neuro-modulating technique, has been developed as a new therapeutic option for neuropsychiatric disorders. It encompasses the induction of a relatively weak constant current flow through the cerebral cortex via scalp electrodes. Dependent on stimulation polarity, this results in a modulation of cortical excitability and spontaneous neural activity. Compared with tDCS, high-definition transcranial direct current stimulation (HD-tDCS) is highly focal and can specifically modulate cortical activity within the region confined by its 4 x 1 ring of elctrodes, such that the targeted region becomes more amenable to neuroplastic change. Studies have suggested that tDCS improve cognition, including memory recall, verbal fluency and executive function. Yet, there is not HD-tDCS study on MCI. The purpose of this study is to examine whether HD-tDCS could benefit global cognitive function and sub-domains of cognition (visual/verbal/working memory, executive function, attention, processing speed, language, and frontal lobe function), mood (depression and anxiety), and subjective memory impairment in patients with mild cognitive impairment.
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 |
|---|---|---|
| 2 milli Amp dose of HD-tDCS treatment | Active comparator | Device: HD-tDCS treatment2 milli Amp dose of HD-tDCS treatment for for 25 minutes, once working day for 2 weeks, total 10 sessions |
| Sham (placebo) dose of HD-tDCS treatment | Sham comparator | Device: sham (placebo) HD-tDCSSham (placebo) dose of HD-tDCS treatment for 25 minutes, once working day for 2 weeks, total 10 sessions |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Aged 65 to 85 years
- mild cognitive impairment
- right handed
Key exclusion criteria (5 listed)
- Having epilepsy, severe physical illness, any current psychiatric comorbidity or history of substance dependence
- Having contraindications for transcranial electrical/magnetic stimulation.
- Having intracranial metal foreign bodies
- Having a history of intracranial neoplasms or surgery, or a history of severe head injuries or cerebrovascular diseases
- Receiving psychotropic agents such as antipsychotic, antidepressant, benzodiazepam and anxiolytics etc.
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-tDCS treatment2 milli Amp dose of HD-tDCS treatment for for 20 minutes, for 5 consecutive twice daily sessions | Device | 2 milli Amp dose of HD-tDCS treatment |
| sham (placebo) HD-tDCSParticipants will receive sham (placebo) HD-tDCS for 20 minutes, for 5 consecutive twice daily sessions | Device | Sham (placebo) dose of HD-tDCS treatment |
Primary outcome
Cognitive Abilities Screening Instrument, CASI
Time frame: Change from baseline after one week, one and three months
The Cognitive Abilities Screening Instrument (CASI) is a cognitive test screening for dementia, in monitoring the disease progression, and in providing profiles of cognitive impairment by examining abilities on attention, concentration, orientation, short-term memory, long-term memory, language abilities, visual construction, list-generating fluency, abstraction, and judgment with score ranges of 0 to 100, respectively.
Wechsler Memory Scale-third edition (WMS III) - verbal paired associates I and II
Time frame: Change from baseline after one week, one and three months
For assessing verbal memory by assessing recall memory for orally presented word pairs that have been previously learned (verbal paired associates I); assessing ability to recall associations from Verbal Paired Associates I after a 30-minute delay, as well as assessing recognition of word pairs (verbal paired associates II).
Wechsler Memory Scale-third edition (WMS III) - visual reproduction I and II
Time frame: Change from baseline after one week, one and three months
For assessing visual memory function by assessing ability to reproduce difficult-to-verbalize designs after a brief exposure (visual reproduction I); assessing ability to recall the designs presented in Visual Reproduction I after a 30-minute delay, as well as specific sub-subtests to assess recognition of correct figures from nontarget figures, copying of figures to assess visual perception abilities, and a subtest to analyze discrimination abilities (visual reproduction II).
Wisconsin card sorting test
Time frame: Change from baseline after one week, one and three months
for assessing executive function
Frontal assessment battery, FAB
Time frame: Change from baseline after one week, one and three months
The FAB is a brief tool that can be used at the bedside or in a clinic setting to assist frontal function of subjects. Total score is from a maximum of 18, higher scores indicating better performance. The scales consist similarities (conceptualization), lexical fluency (mental flexibility), motor series "Luria" test (programming), conflicting instructions (sensitivity to interference), Go-No Go (inhibitory control), prehension behaviour (environmental autonomy).
Wechsler adult intelligence scale four edition, WAIS-IV, digit span
Time frame: Change from baseline after one week, one and three months
The Wechsler Adult Intelligence Scale (WAIS) is an IQ test designed to measure intelligence and cognitive ability in adults and older adolescents. It is currently in its fourth edition (WAIS-IV) released in 2008 by Pearson, and is the most widely used IQ test, for both adults and older adolescents, in the world. We used WAIS-IV, digit span subscale, to examine attention among subjects; Digit span was by listening to sequences of numbers orally and to repeat them as heard, in reverse order, and in ascending order.
Wechsler adult intelligence scale four edition, WAIS-IV, digit symbol coding
Time frame: Change from baseline after one week, one and three months
We used WAIS-IV, digit symbol coding subscale, to examine processing speed among subjects; The digit symbol coding is a paper-and-pencil cognitive test presented on a single sheet of paper that requires a subject to match symbols to numbers according to a key located on the top of the page. The subject copies the symbol into spaces below a row of numbers. The number of correct symbols within the allowed time, usually 90 to 120 seconds, constitutes the score
Wechsler adult intelligence scale four edition, WAIS-IV, vocabulary
Time frame: Change from baseline after one week, one and three months
We used WAIS-IV, vocabulary subscale, to examine language function among subjects; The vocabulary subtest requires the client to try to define up to 30 words. This subtest assesses the client's understanding of words and reflects: language development, expressive language skills, cultural and educational experiences, ability to use words appropriately, retrieval of information from long-term memory.
3 secondary outcomes
Beck depression inventory (BDI-II)
Time frame: Change from baseline after one week, one and three months
Beck anxiety inventory (BAI)
Time frame: Change from baseline after one week, one and three months
Subjective Cognitive Decline Questionnaire (SCD-Q MyCog)
Time frame: Change from baseline after one week, one and three months
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 31 Oct 2024.
- Derived from this study: PubMed 40984052Chu CS, Chang HA, Lin YT, Shen HC, Liang CK, Hsu YH, Pan CC, Kuo HY, Liang WZ, Chen SL, Chen CS. Effectiveness and safety of high-definition transcranial direct current stimulation in patients with mild cognitive impairment: A randomized, triple-blind, sham-controlled trial. J Alzheimers Dis. 2025 Nov;108(1):298-311. doi: 10.1177/13872877251376547. Epub 2025 Sep 22.
- 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. This study is not recruiting at the moment.
Che-Sheng Chu, MD principal investigator
Kaohsiung Veterans General Hospital.
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 treatment in people with Mild Cognitive Impairment, run by Kaohsiung Veterans General Hospital. at 1 site in Taiwan.
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 3 inclusion and 5 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 31 Oct 2024. 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 Taiwan. 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?
Cognitive Abilities Screening Instrument, CASI (time frame: Change from baseline after one week, one and three months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04121156, which also lists 1 linked publication.
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 31 Oct 2024.