Clinical trial NCT03441152: The Effects of Transcranial Direct Current Stimulation in Mild Cognitive Impairment
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mild Cognitive Impairment
Keywords: Mild Cognitive Impairment
Neuromodulation
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2018-02-22
Enrollment: 66
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: 10 minutes
measure: Digit Span Test
timeFrame: 10 minutes
measure: Trial Making Test (TMT)
timeFrame: 5 minutes
Secondary outcomes:
measure: Riverhead Behavioral Memory Test (3rd edition) (RBMT-3)
timeFrame: 40 minutes
Other outcomes:
measure: Cognitive training activities ( Neuronup cognitive training)
timeFrame: 30 minutes each session ( 9 sessions in total)
measure: EEG
timeFrame: 15 minutes
Locations:
city: Hong Kong
country: Hong Kong
facility: The Hong Kong Polytechnic University
Study officials:
References:
citation: 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.