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High Definition Transcranial Direct Current Stimulation (HD-tDCS) in Patients With Mild Cognitive Impairment

Primary Purpose

Mild Cognitive Impairment

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
HD-tDCS treatment
sham (placebo) HD-tDCS
Sponsored by
Kaohsiung Veterans General Hospital.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mild Cognitive Impairment

Eligibility Criteria

65 Years - 85 Years (Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of PsychiatryRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

2 milli Amp dose of HD-tDCS treatment

Sham (placebo) dose of HD-tDCS treatment

Arm Description

2 milli Amp dose of HD-tDCS treatment for for 20 minutes, for 5 consecutive twice daily sessions

Sham (placebo) dose of HD-tDCS treatment for 20 minutes, for 5 consecutive twice daily sessions

Outcomes

Primary Outcome Measures

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.
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).
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).
Wisconsin card sorting test
for assessing executive function
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).
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.
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
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.

Secondary Outcome Measures

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.
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.
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).

Full Information

First Posted
October 8, 2019
Last Updated
January 13, 2023
Sponsor
Kaohsiung Veterans General Hospital.
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1. Study Identification

Unique Protocol Identification Number
NCT04121156
Brief Title
High Definition Transcranial Direct Current Stimulation (HD-tDCS) in Patients With Mild Cognitive Impairment
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 30, 2020 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kaohsiung Veterans General Hospital.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
2 milli Amp dose of HD-tDCS treatment
Arm Type
Active Comparator
Arm Description
2 milli Amp dose of HD-tDCS treatment for for 20 minutes, for 5 consecutive twice daily sessions
Arm Title
Sham (placebo) dose of HD-tDCS treatment
Arm Type
Sham Comparator
Arm Description
Sham (placebo) dose of HD-tDCS treatment for 20 minutes, for 5 consecutive twice daily sessions
Intervention Type
Device
Intervention Name(s)
HD-tDCS treatment
Intervention Description
2 milli Amp dose of HD-tDCS treatment for for 20 minutes, for 5 consecutive twice daily sessions
Intervention Type
Device
Intervention Name(s)
sham (placebo) HD-tDCS
Intervention Description
Participants will receive sham (placebo) HD-tDCS for 20 minutes, for 5 consecutive twice daily sessions
Primary Outcome Measure Information:
Title
Cognitive Abilities Screening Instrument, CASI
Description
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.
Time Frame
Change from baseline after one week, one and three months
Title
Wechsler Memory Scale-third edition (WMS III) - verbal paired associates I and II
Description
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).
Time Frame
Change from baseline after one week, one and three months
Title
Wechsler Memory Scale-third edition (WMS III) - visual reproduction I and II
Description
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).
Time Frame
Change from baseline after one week, one and three months
Title
Wisconsin card sorting test
Description
for assessing executive function
Time Frame
Change from baseline after one week, one and three months
Title
Frontal assessment battery, FAB
Description
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).
Time Frame
Change from baseline after one week, one and three months
Title
Wechsler adult intelligence scale four edition, WAIS-IV, digit span
Description
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.
Time Frame
Change from baseline after one week, one and three months
Title
Wechsler adult intelligence scale four edition, WAIS-IV, digit symbol coding
Description
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
Time Frame
Change from baseline after one week, one and three months
Title
Wechsler adult intelligence scale four edition, WAIS-IV, vocabulary
Description
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.
Time Frame
Change from baseline after one week, one and three months
Secondary Outcome Measure Information:
Title
Beck depression inventory (BDI-II)
Description
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.
Time Frame
Change from baseline after one week, one and three months
Title
Beck anxiety inventory (BAI)
Description
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.
Time Frame
Change from baseline after one week, one and three months
Title
Subjective Cognitive Decline Questionnaire (SCD-Q MyCog)
Description
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).
Time Frame
Change from baseline after one week, one and three months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Che-Sheng Chu, MD
Phone
+886-7-3422121
Ext
2068
Email
cschu@vghks.gov.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Che-Sheng Chu, MD
Organizational Affiliation
Kaohsiung Veterans General Hospital.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Psychiatry
City
Kaohsiung
ZIP/Postal Code
813
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Che-Sheng Chu, MD
Phone
886-7-3422121
Email
youngtzuchi@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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High Definition Transcranial Direct Current Stimulation (HD-tDCS) in Patients With Mild Cognitive Impairment

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