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

NCT04121156 | Completed DMC

• 1 other identifier: VGHKS-2068
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Mild Cognitive Impairment

Outcome Measures

Primary Outcomes (8)

• 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.

  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).

  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).

  Change from baseline after one week, one and three months

• Wisconsin card sorting test

  for assessing executive function

  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).

  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.

  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

  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.

  Change from baseline after one week, one and three months

Secondary Outcomes (3)

• Beck depression inventory (BDI-II)

  Change from baseline after one week, one and three months

• Beck anxiety inventory (BAI)

  Change from baseline after one week, one and three months

• Subjective Cognitive Decline Questionnaire (SCD-Q MyCog)

  Change from baseline after one week, one and three months

Study Arms (2)

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

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

Device: sham (placebo) HD-tDCS

Interventions

HD-tDCS treatment DEVICE

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

sham (placebo) HD-tDCS DEVICE

Participants will receive sham (placebo) HD-tDCS for 20 minutes, for 5 consecutive twice daily sessions

Sham (placebo) dose of HD-tDCS treatment

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Aged 65 to 85 years
• mild cognitive impairment
• right handed

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kaohsiung Veterans General Hospital.: lead

Study Sites (1)

Department of Psychiatry

Kaohsiung City, 813, Taiwan

Location

Related Publications (1)

• 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.

  PMID: 40984052 DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Che-Sheng Chu, MD

  Kaohsiung Veterans General Hospital.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending physician of department of psychiatry

Study Record Dates

• First Submitted: October 8, 2019
• First Posted: October 9, 2019
• Study Start: September 30, 2020
• Primary Completion: August 31, 2024
• Study Completion: August 31, 2024
• Last Updated: October 31, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)