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CompletedNCT03441152Updated Feb 2, 2023

The Effects of Transcranial Direct Current Stimulation in Mild Cognitive Impairment

An interventional study of tDCS in Mild Cognitive Impairment, sponsored by The Hong Kong Polytechnic University. Completed at 1 site in Hong Kong. Open to participants aged 60 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-02-02.

Sponsored by The Hong Kong Polytechnic University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
66
Allocation
Randomized
Ages
60 Years to 85 Years
Sex
All
01

Study summary

Objectives: 1) To examine whether the real transcranial direct current stimulation (tDCS) group would perform better in the cognitive training (CT) intervention than the sham tDCS group and the CT group; 2) To determine if, as a consequence of the stimulation generated by the use of tDCS, there would be a transfer effect to other cognitive domains and to cognitive tasks in activities of daily living; 3) To investigate the time and spatial responses of tDCS on the brain cortex during and after tDCS application.

Hypothesis to be tested: By applying anodal tDCS with the combination of a CT delivered via the use of tablet PCs in older adults at risk of MCI, it will enhance their cognitive task performance in CT and subsequently generalize to other cognitive domains as well, involving a transferability to cognitive tasks in activities of daily living.

Design and subjects: A multi-centered single-blinded randomized controlled trial (RCT) with three groups (CT alone/Sham tDCS with the combination of a CT/ Real tDCS coupling with CT) The participants who will take part of this study will be older adults at risk of MCI Study instruments: tDCS, Ipad, Neuron Up CT Apps, EEG. Interventions: The intervention will last for 9 sessions (3 sessions per week for 3 weeks). Sham tDCS and real tDCS, will be combined with the same CT which is used in the CT group. During the experimental intervention, anodal tDCS will be placed on left dorsolateral prefrontal cortex (DLPFC) and cathodal tDCS on the contralateral deltoid muscle with the combination of a CT. During the experimental intervention, anodal tDCS will be placed on left dorsolateral prefrontal cortex (DLPFC) and cathodal tDCS on the contralateral deltoid muscle with the combination of a CT.

Main outcome measures: Cognitive assessments, CT performance, EEG. In addition, delta and theta frequency suppression and alpha increment power under the anode electrode will be observed.

02

Conditions studied

  • Mild Cognitive Impairment

Keywords

  • Mild Cognitive Impairment
  • Neuromodulation
03

Who can participate

Ages eligible
60 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • The inclusion criteria will follow the modified Petersen's criteria:

    1. Aged between 60 and 85 years old;
    2. Obtaining a score on the Montreal Cognitive Assessment Test (MoCA) between 19 and 26;
    3. Achieving a score on the Clinical Dementia Rating (CDR) of 0.5 or below ;
    4. Self-reported cognitive decline by the participants themselves and
    5. Being independent in daily living activities.

      Additional criteria in this study include:

    6. Having completed three or more years of primary education;
    7. Ability to participate in a therapy session lasting at least 30 minutes;
    8. Community ambulant with or without aids; and
    9. Ability to perform a proper range of motion with hands in order to use a tablet PC.

Exclusion criteria

Exclusion Criteria:

    1. Individuals presenting with a diagnosis of dementia or any other neurological disease; (2) Individuals with depression determined by a score on Geriatric Depression Scale of >5, (3) History of drug or alcohol abuse or dependence in the last 3 months; and (4) Participants who had metallic fixtures around the cephalic area or skin lesions in the areas at where the electrodes were going to be attached were excluded from the study.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
66 participants (actual)

Study arms

  • Experimental
    tDCS+CT

    application of tDCS in combination with CT

    Device: tDCS

  • Sham comparator
    Sham tDCS

    application of sham tDCS in combination with CT

    Device: tDCS

  • Active comparator
    CT

    application of CT

    Device: tDCS

Interventions

  • DevicetDCS

    Transcranial direct current stimulation

05

What researchers measure

Primary outcomes

  1. Montreal Cognitive Assessment (MoCA)

    It is a 30-point test about several cognitive domains (visuospatial/executive, naming, memory, attention, language, abstraction, delayed recall and orientation) and a screening tool used of MCI and dementia.

    Time frame: 10 minutes

  2. Digit Span Test

    The test measures short term memory in such a way that sequences of digits are presented and have to be recalled in forward and reverse order. Testing ends when the maximal list length is reached or when subjects fail to recall the trial at one sequence length.

    Time frame: 10 minutes

  3. Trial Making Test (TMT)

    TMT encompasses visual attention and processing speed, it consists of 2 parts in which a set of 25 dots in the first part and 24 dots in the second part have to be accurately connected. Time performance is measured as the main outcome

    Time frame: 5 minutes

Secondary outcomes

  1. Riverhead Behavioral Memory Test (3rd edition) (RBMT-3)

    It includes 14 subtests assessing aspects of visual, verbal, recall, recognition, immediate and delayed everyday memory. Additionally prospective memory skills and the ability to learn new information are measured as well

    Time frame: 40 minutes

Other outcomes

  1. Cognitive training activities ( Neuronup cognitive training)

    Performance of the cognitive training activities conducted every session

    Time frame: 30 minutes each session ( 9 sessions in total)

  2. EEG

    time and spatial responses of tDCS on the brain cortex before and after tDCS application

    Time frame: 15 minutes

06

Study locations

1 site
  • The Hong Kong Polytechnic University
    Hong Kong, Hung Hom, Hong Kong
07

References and documents

Publications

  • Gonzalez PC, Fong KNK, Brown T. Transcranial direct current stimulation as an adjunct to cognitive training for older adults with mild cognitive impairment: A randomized controlled trial. Ann Phys Rehabil Med. 2021 Sep;64(5):101536. doi: 10.1016/j.rehab.2021.101536. Epub 2021 Jul 20. PubMed 33957292 ↗

Individual participant data

Plan to share: Undecided

08

Registry details

Key details

Study ID
NCT03441152
Lead sponsor
The Hong Kong Polytechnic University
Responsible party
Kenneth N. K. Fong (Associate Professor, The Hong Kong Polytechnic University) — Principal investigator
First posted
Feb 22, 2018
Start date
Jul 1, 2017
Primary completion
Aug 30, 2018
Completion
Aug 30, 2018
Last update
Feb 2, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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