The Effects of Transcranial Direct Current Stimulation in Mild Cognitive Impairment

NCT03441152 | Completed

• 1 other identifier: HongKongPUPabloRS
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Mild Cognitive Impairment

Keywords

Mild Cognitive Impairment; Neuromodulation

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Riverhead Behavioral Memory Test (3rd edition) (RBMT-3)

  40 minutes

Other Outcomes (2)

• Cognitive training activities ( Neuronup cognitive training)

  30 minutes each session ( 9 sessions in total)

• EEG

  15 minutes

Study Arms (3)

tDCS+CT

EXPERIMENTAL

application of tDCS in combination with CT

Device: tDCS

Sham tDCS

SHAM COMPARATOR

application of sham tDCS in combination with CT

Device: tDCS

CT

ACTIVE COMPARATOR

application of CT

Device: tDCS

Interventions

tDCS DEVICE

Transcranial direct current stimulation

CT; Sham tDCS; tDCS+CT

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged between 60 and 85 years old;
• Obtaining a score on the Montreal Cognitive Assessment Test (MoCA) between 19 and 26;
• Achieving a score on the Clinical Dementia Rating (CDR) of 0.5 or below ;
• Self-reported cognitive decline by the participants themselves and
• Being independent in daily living activities.
• Additional criteria in this study include:
• Having completed three or more years of primary education;
• Ability to participate in a therapy session lasting at least 30 minutes;
• Community ambulant with or without aids; and
• Ability to perform a proper range of motion with hands in order to use a tablet PC.

You may not qualify if:

• \) 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.

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (1)

The Hong Kong Polytechnic University

Hong Kong, Hung Hom, Hong Kong

Location

Related Publications (1)

• 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.

  PMID: 33957292 DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 5, 2018
• First Posted: February 22, 2018
• Study Start: July 1, 2017
• Primary Completion: August 30, 2018
• Study Completion: August 30, 2018
• Last Updated: February 2, 2023

Record last verified: 2023-01

Locations

HK (1)