TDCS as Augmentation Therapy to Cognitive Training in Mild Dementia

August 14, 2024 updated by: Tam Tsz Ying, Hospital Authority, Hong Kong

Randomized Controlled Trial of Transcranial Direct Current Stimulation (tDCS) as Augmentation Therapy to Cognitive Training (CT) in Individuals With Major Neurocognitive Disorder (MND) of Mild Severity

Due to increase in life expectancy, major neurocognitive disorder (MND) becoming increasingly important as reflected in the increasing number in dementia population, as well as in burden to health care system and to caregiver.

Among current treatment, cognitive training has shown to have significant outcome in cognitive impaired patient. But the effect is reported to be small and might not be long-lasting. In consideration of the neuronal excitability effect in tDCS, it may consolidate the effect of cognitive training if used simultaneously. The study will investigate on efficacy of tDCS as combined intervention to cognitive training.

The study aims to investigate the efficacy of 2-week (5 sessions per week) tDCS to augment cognitive training in subjects with MND with clinically mild severity. Patients with diagnosis of MND or dementia from HKWC will be recruited with inclusion and exclusion criteria listed. The eligible participants will be randomized to receive either active intervention (active tDCS) or sham (sham tDCS) as control with cognitive training simultaneously.

Each session lasts for 20 minutes. The subjects will be allocated to either interventional or control group using block randomization. Block of 4 will be used to allocate subjects at 1:1 ratio between two groups. Both the participants and investigators responsible for assessment and data analysis will be blinded to the group allocation. Primary and secondary outcome will be assessed at baseline, week 2 (after course of intervention) and 4 weeks after the course of intervention. Baseline assessment assesses on demographic data (e.g. age, gender, years of education), clinical data with full psychiatric assessment and access to previous medical record, neuropsychiatric data (HK-MoCA and CNPI). Primary outcomes includes N-back (cognitive training) performance, forward and backward digit span. Secondary outcomes includes measurement on dementia rating and trail making test. In data analysis, any group differences in demographics and clinical profiles between the intervention and sham group at baseline will be assess. ANOVA will be performed to examine the effect of time and intervention on primary outcome and other cognitive assessment across time points. Potential confounders will be adjusted.

Baseline assessments and outcome measures is either psychiatric assessment, clinician rating scales or cognitive assessment performed with investigator.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Due to increase in life expectancy, major neurocognitive disorder (MND) becoming increasingly important as reflected in the increasing number in dementia population, as well as in burden to health care system and to caregiver.

Among current treatment, cognitive training has shown to have significant outcome in cognitive impaired patient. But the effect is reported to be small and might not be long-lasting. In consideration of the neuronal excitability effect in tDCS, it may consolidate the effect of cognitive training if used simultaneously. The study will investigate on efficacy of tDCS as combined intervention to cognitive training.

The study aims to investigate the efficacy of 2-week (5 sessions per week) tDCS to augment cognitive training in subjects with major neurocognitive disorder with clinically mild severity. Patients with diagnosis of MND or dementia from HKWC will be recruited with inclusion and exclusion criteria listed. The eligible participants will be randomized to receive either active intervention (active tDCS) or sham (sham tDCS) as control with cognitive training simultaneously.

Each session lasts for 20 minutes. The subjects will be allocated to either interventional group or control group using block randomization. Block of 4 will be used to allocate subjects at 1:1 ratio between two groups. Both the participants and investigators responsible for assessment and data analysis will be blinded to the group allocation. Primary outcome and secondary outcome will be assessed at baseline, week 2 (after course of intervention) and 4 weeks after the course of intervention. Baseline assessment assesses on demographic data (e.g. age, gender, years of education), clinical data with full psychiatric assessment and access to previous medical record, neuropsychiatric data (HK-MoCA and CNPI). Primary outcomes includes N-back (cognitive training) performance, forward and backward digit span. Secondary outcomes includes measurement on dementia rating and trail making test. In data analysis, any group differences in demographics and clinical profiles between the intervention and sham group at baseline will be assess. ANOVA will be performed to examine the effect of time and intervention on primary outcome and other cognitive assessment across time points. Potential confounders will be adjusted.

Baseline assessments and outcome measures is either psychiatric assessment, clinician rating scales or cognitive assessment performed with investigator. No questionnaires will be given to participants.

Study Type

Interventional

Enrollment (Estimated)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Queen Mary Hospital
        • Contact:
        • Contact:
          • Pak Wing Cheng, MBBS, HKU
          • Phone Number: 85270835708
          • Email: chengpsy@hku.hk
        • Sub-Investigator:
          • Tsz Ying Tam, MBBS, HKU
        • Principal Investigator:
          • Pak Wing Cheng, MBBS, HKU

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 65 years of age or above
  • Right-handedness Chinese as defined by Edinburgh handedness inventory
  • Cantonese speaking
  • Fulfil the criteria of Major neurocognitive disorder, as defined by the 5 th Edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM- 5)
  • Clinical Dementia Rating Global score = 1

Exclusion Criteria:

  • Active diagnosis of mood disorder or psychosis
  • Alcohol or substance dependence
  • Initiation or change in dose of cognitive enhancer within 6 months prior to the onset of the study 14
  • Poor physical condition and mobility
  • Having regular cognitive training (as defined by at least three 1-hour weekly structured and standardized cognitive training in recent 3 months) 15
  • Receiving tDCS within 2 months prior to the onset of study 16
  • Significant communication or visual impairment
  • Having metal implant in area above upper back, or having metal crown or metal brace, or pacemaker

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: active tdcs with cognitive training
active transcranial direct current stimulation with cognitive training by N-back using computerized programme
Device: transcranial direct current stimulation
Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation by applying weak current through electrode. It can archive excitation by anode stimulation or inhibition by stimulating cathode. By inducing modification of membrane polarisation, it can modulate cerebral excitability. Literature suggested anode tDCS over the dorsolateral prefrontal cortex (DLPFC) improved cognitive function, in terms of responding faster and more accurate in cognitive tasks. tDCS was well tolerated and accepted by participants.
Sham Comparator: Sham tdcs with cognitive training
Sham transcranial direct current stimulation with cognitive training by N-back using computerized programme
Device: transcranial direct current stimulation
Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation by applying weak current through electrode. It can archive excitation by anode stimulation or inhibition by stimulating cathode. By inducing modification of membrane polarisation, it can modulate cerebral excitability. Literature suggested anode tDCS over the dorsolateral prefrontal cortex (DLPFC) improved cognitive function, in terms of responding faster and more accurate in cognitive tasks. tDCS was well tolerated and accepted by participants.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
N-back task performance in terms of reaction time and % of correct
Time Frame: Baseline, week 2 (after course of intervention) and 4 weeks after the course of intervention
N-back task performance in terms of reaction time and % of correct. The data will be measured in the computerized programme.
Baseline, week 2 (after course of intervention) and 4 weeks after the course of intervention
Forward and Backward digit span
Time Frame: Baseline, week 2 (after course of intervention) and 4 weeks after the course of intervention
Digit span is widely used to test verbal working memory. It can be assessed in forward (forward digit span) and reverse order (backward digit span). It is also a component in Wechsler Adult Intelligence Scale.
Baseline, week 2 (after course of intervention) and 4 weeks after the course of intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical dementia rating - sum of boxes
Time Frame: Baseline, week 2 (after course of intervention) and 4 weeks after the course of intervention
Clinical dementia rating (CDR) is a 5-point scale to assess six domains of cognitive and functional performance. The Clinical Dementia Rating Scale Sum of Boxes (CDR-SOB) has increased utility in detecting difference between stages of dementia severity.
Baseline, week 2 (after course of intervention) and 4 weeks after the course of intervention
Chinese version of the neuropsychiatric inventory (CNPI)
Time Frame: Baseline, week 2 (after course of intervention) and 4 weeks after the course of intervention
CNPI is developed by Cummings et al. It assesses 12 aspects in neuropsychiatric disturbances, e.g. agitation, anxiety, irritability. The modified version of NPI also evaluate carer distress.
Baseline, week 2 (after course of intervention) and 4 weeks after the course of intervention
Trail making test
Time Frame: Baseline, week 2 (after course of intervention) and 4 weeks after the course of intervention
Trail Making Test (TMT) is widely used test to assess attention, psychomotor speed and mental flexibility. Trail making test - black and white (TMT-B&W) used numbers in circle with black and white background instead of use of the English alphabet in Trail Making Test part B (TMT B). It is more user friendly in individuals would might not be able to read English letters.
Baseline, week 2 (after course of intervention) and 4 weeks after the course of intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Authority, Hong Kong

Collaborators

The University of Hong Kong

Investigators

  • Principal Investigator: Pak Wing Cheng, MBBS, HKU, The University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2024

Primary Completion (Estimated)

April 30, 2025

Study Completion (Estimated)

September 30, 2025

Study Registration Dates

First Submitted

August 13, 2024

First Submitted That Met QC Criteria

August 14, 2024

First Posted (Actual)

August 19, 2024

Study Record Updates

Last Update Posted (Actual)

August 19, 2024

Last Update Submitted That Met QC Criteria

August 14, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UW 24-305

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Need to further liase with hospital authority over data share for research purpose.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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