- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04121156
High Definition Transcranial Direct Current Stimulation (HD-tDCS) in Patients With Mild Cognitive Impairment
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Che-Sheng Chu, MD
- Phone Number: 2068 +886-7-3422121
- Email: cschu@vghks.gov.tw
Study Locations
-
-
-
Kaohsiung, Taiwan, 813
- Recruiting
- Department of Psychiatry
-
Contact:
- Che-Sheng Chu, MD
- Phone Number: 886-7-3422121
- Email: youngtzuchi@hotmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Aged 65 to 85 years
- mild cognitive impairment
- right handed
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 2 milli Amp dose of HD-tDCS treatment
2 milli Amp dose of HD-tDCS treatment for for 20 minutes, for 5 consecutive twice daily sessions
|
2 milli Amp dose of HD-tDCS treatment for for 20 minutes, for 5 consecutive twice daily sessions
|
Sham Comparator: Sham (placebo) dose of HD-tDCS treatment
Sham (placebo) dose of HD-tDCS treatment for 20 minutes, for 5 consecutive twice daily sessions
|
Participants will receive sham (placebo) HD-tDCS for 20 minutes, for 5 consecutive twice daily sessions
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Change from baseline after one week, one and three months
|
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).
|
Change from baseline after one week, one and three months
|
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).
|
Change from baseline after one week, one and three months
|
Wisconsin card sorting test
Time Frame: Change from baseline after one week, one and three months
|
for assessing executive function
|
Change from baseline after one week, one and three months
|
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).
|
Change from baseline after one week, one and three months
|
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. |
Change from baseline after one week, one and three months
|
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
|
Change from baseline after one week, one and three months
|
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.
|
Change from baseline after one week, one and three months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Beck depression inventory (BDI-II)
Time Frame: Change from baseline after one week, one and three months
|
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.
|
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
|
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.
|
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
|
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).
|
Change from baseline after one week, one and three months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Che-Sheng Chu, MD, Kaohsiung Veterans General Hospital.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- VGHKS-2068
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Mild Cognitive Impairment
-
University of California, San FranciscoNational Institute on Aging (NIA)RecruitingMild Cognitive Impairment | Cognitive Decline | Cognitive Deterioration | Cognitive Impairment, Mild | Cognitive Deficits, MildUnited States
-
BaycrestCentre for Aging and Brain Health InnovationUnknownNeurocognitive Disorders | Cognitive Dysfunction | Mental Disorder | Cognitive Impairment, Mild | Cognitive Disorder | Nonamnestic Mild Cognitive ImpairmentCanada
-
Mackay Memorial HospitalBened Biomedical Co., Ltd.RecruitingMild Cognitive Impairment (MCI)Taiwan
-
Thomas Jefferson UniversityJohns Hopkins University; University of Pennsylvania; National Institute on Aging... and other collaboratorsCompletedMild Cognitive Impairment (MCI)United States
-
Palo Alto Veterans Institute for ResearchU.S. Army Medical Research and Development CommandCompletedAmnestic Mild Cognitive ImpairmentUnited States
-
Assaf-Harofeh Medical CenterNeurim Pharmaceuticals Ltd.UnknownMild Cognitive Impairment (MCI)Israel
-
Xuanwu Hospital, BeijingWuhan University; Beijing Friendship Hospital; First Affiliated Hospital Xi'an... and other collaboratorsRecruitingAmnestic Mild Cognitive ImpairmentChina
-
Immunotec Inc.RecruitingMild Cognitive Impairment (MCI)Canada
-
Jennifer BramenNational Institutes of Health (NIH); National Institute on Aging (NIA)CompletedAmnestic Mild Cognitive ImpairmentUnited States
-
Meir Medical CenterTerminatedMild Cognitive Impairment (MCI)Israel
Clinical Trials on HD-tDCS treatment
-
Ariel UniversityTel Aviv UniversityCompleted
-
The University of Texas at DallasCompleted
-
Shanghai Mental Health CenterChinese Academy of SciencesTerminated
-
University of MichiganNational Institute on Aging (NIA)RecruitingMild Cognitive Impairment | Dementia of Alzheimer TypeUnited States
-
University of California, Los AngelesNational Institute of Mental Health (NIMH); National Institutes of Health (NIH)Active, not recruitingMajor Depressive DisorderUnited States
-
Chinese University of Hong KongCompleted
-
University of California, Los AngelesNational Institute of Mental Health (NIMH)Completed
-
Federal University of ParaíbaUniversity of Michigan; Rio de Janeiro State University; City University of New...RecruitingCoronavirus | COVID-19 Respiratory InfectionBrazil
-
Chinese University of Hong KongRecruiting
-
University of MichiganNational Institute of Dental and Craniofacial Research (NIDCR)TerminatedTemporomandibular DisorderUnited States