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

Overview

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.

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: August 31, 2022

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.

Interventions

  • Device: HD-tDCS treatment
    • 2 milli Amp dose of HD-tDCS treatment for for 20 minutes, for 5 consecutive twice daily sessions
  • Device: sham (placebo) HD-tDCS
    • Participants will receive sham (placebo) HD-tDCS for 20 minutes, for 5 consecutive twice daily sessions

Arms, Groups and Cohorts

  • 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
  • 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

Clinical Trial Outcome Measures

Primary Measures

  • 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, WMS-III, verbal paired associates
    • Time Frame: Change from baseline after one week, one and three months
    • for assessing verbal memory function
  • Wechsler memory scale, WMS-III, visual reproduction
    • Time Frame: Change from baseline after one week, one and three months
    • for assessing visual memory function
  • 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
    • for assessing frontal lobe function
  • Wechsler adult intelligence scale, WAIS-IV, digit span
    • Time Frame: Change from baseline after one week, one and three months
    • for assessing attention
  • Wechsler adult intelligence scale, WAIS-IV, digit symbol coding
    • Time Frame: Change from baseline after one week, one and three months
    • for assessing processing speed
  • Wechsler adult intelligence scale, WAIS-IV, vocabulary
    • Time Frame: Change from baseline after one week, one and three months
    • for assessing language function

Secondary Measures

  • Beck depression inventory (BDI-II)
    • Time Frame: Change from baseline after one week, one and three months
    • for assessing severity of depression
  • Beck anxiety inventory (BAI)
    • Time Frame: Change from baseline after one week, one and three months
    • for assessing severity of anxiety
  • Subjective Cognitive Decline Questionnaire (SCD-Q MyCog)
    • Time Frame: Change from baseline after one week, one and three months
    • for assessing subjective memory ability

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 65 Years

Maximum Age: 85 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Kaohsiung Veterans General Hospital.
  • Provider of Information About this Clinical Study
    • Principal Investigator: Che-Sheng Chu, Department of Psychiatry – Kaohsiung Veterans General Hospital.
  • Overall Official(s)
    • Che-Sheng Chu, MD, Principal Investigator, Kaohsiung Veterans General Hospital.
  • Overall Contact(s)
    • Che-Sheng Chu, MD, +886-7-3422121, cschu@vghks.gov.tw

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