The Effects of Transcranial Direct Current Stimulation in Mild Cognitive Impairment

The Neural Effects of Multisession Transcranial Direct Current Stimulation in Older Adults at Risk for Mild Cognitive Impairment and Its Impact in Cognitive Functions and Everyday Memory: A Randomized Controlled Trial

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.

Study Overview

• Status: Unknown
• Conditions: Mild Cognitive Impairment
• Intervention / Treatment: Device: tDCS

• Study Type: Interventional
• Enrollment (Anticipated): 66
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pablo Cruz Gonzalez; Phone Number: +852 62382024; Email: pablo.cruzgonzalez@connect.polyu.hk
• Study Contact Backup: Name: Kenneth Fong; Phone Number: +852 2766 6716; Email: rsnkfong@polyu.edu.hk

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong, Hung Hom
    • Recruiting
    • The Hong Kong Polytechnic University
    • Contact: Pablo Cruz Gonzalez; Phone Number: +85262382024; Email: pablo.cruzgonzalez@connect.polyu.hk
    • Contact: Kenneth Fong; Phone Number: +85227666716; Email: rsnkfong@polyu.edu.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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:

• 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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: tDCS+CT; application of tDCS in combination with CT	Device: tDCS; Transcranial direct current stimulation
Sham Comparator: Sham tDCS; application of sham tDCS in combination with CT	Device: tDCS; Transcranial direct current stimulation
Active Comparator: CT; application of CT	Device: tDCS; Transcranial direct current stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	10 minutes
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.	10 minutes
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	5 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	40 minutes

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cognitive training activities ( Neuronup cognitive training)	Performance of the cognitive training activities conducted every session	30 minutes each session ( 9 sessions in total)
EEG	time and spatial responses of tDCS on the brain cortex before and after tDCS application	15 minutes

Collaborators and Investigators

• Sponsor: The Hong Kong Polytechnic University

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2017
• Primary Completion (Anticipated): August 1, 2018
• Study Completion (Anticipated): August 1, 2018

Study Registration Dates

• First Submitted: February 5, 2018
• First Submitted That Met QC Criteria: February 20, 2018
• First Posted (Actual): February 22, 2018

Study Record Updates

• Last Update Posted (Actual): February 22, 2018
• Last Update Submitted That Met QC Criteria: February 20, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: Neuromodulation; Mild Cognitive Impairment
• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: HongKongPUPabloRS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No