Skip to main content
OpenTrials
Completed

NCT Number: NCT03974087

The Effect of Transcranial Direct Current Stimulation on Visual Attention in Mild Cognitive Impairment

Progressively causes the breakdown of cognitive functions and impairs quality of life for patients and their caregivers. In addition to memory impairment, visual attention is also compromised, even at the stage of mild cognitive impairment due to AD (MCI-AD). No treatment has been found for MCI-AD; therefore, attention has been drawn to non-invasive brain stimulation techniques, such as transcranial direct current stimulation (tDCS), in order to enhance cognitive functions by modifying brain plasticity. In the current research, investigator aim to examine the long-term effects of the optimal multiple-session tDCS protocol in MCI-AD on visual attention including the transfer to an ecologically valid virtual environment and identify the neural underpinnings of tDCS-induced behavioral aftereffects using a combined tDCS/ MRI network-based approach.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Mild Cognitive Impairment Cognition Disorders Cognitive Dysfunction Mental Disorders Neurocognitive Disorders

Age range

60 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ceitec, Masaryk University

Brno, 61300, Czechia

About this study

Investigator will investigate the long-term effects of 10 active tDCS consecutive sessions using an optimized stimulation protocol as compared to a placebo stimulation on visual attention in the MCI-AD. A two-parallel-group, randomized, placebo-controlled design will be used. In addition, the cognitive transfer of tDCS will be evaluated. Repeated tDCS sessions will be performed in 10 consecutive sessions (2 weeks: Monday to Friday) over one preselected ROI together with ongoing visual attention training. During the stimulation, investigator will use the visual matching task. Before the repeated stimulation sessions, participants will undergo the neurocognitive examination. Behavioral examinations of the trained and untrained tasks (i.e. the transfer tasks) will be performed to assess the baseline performance. MRI protocol consisting of T1, T2, FLAIR, and fMRI during the task performance (visual matching task), resting state fMRI, and DTI sequences will be acquired before and after the whole 10-day stimulation protocol in order to search for active vs. placebo tDCS-induced changes in brain activation and resting state functional and structural connectivity and to identify neural correlates of behavioral changes. Behavioral assessment of the trained task and the transfer task will be repeated immediately after and again at a one-month follow-up visit after the end of the last stimulation session

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • amnestic single or multi-domain mild cognitive impairment patients in accordance with diagnostic criteria (Albert et al., 2011)

Exclusion criteria

  • psychiatric disorders, including major depression, major vascular lesions, and other brain pathologies detected by MRI that might present with cognitive decline
  • a cardio pacemaker or any MRI-incompatible metal in the body
  • epilepsy
  • any diagnosed psychiatric disorder
  • alcohol/drug abuse
  • lack of cooperation
  • presence of dementia.

Treatment and study plan

Transcranial direct current stimulation (tDCS)

Device

2mA stimulation for 20 minutes

Primary outcomes

  1. Visual-attention task accuracy

    Time frame: Change from baseline immediately after completion of stimulation protocol and one month after completion of stimulation protocol

    Task will be presented on a computer and subject will respond by YES-NO buttons. Only if there are no differences in task accuracy, we will measure task reaction times (e.g. due to the roof effect).

Secondary outcomes

  1. Psychological assessment - z-score computed from multiple psychological domains

    Time frame: Change from baseline immediately after one month from completion of stimulation protocol

    Z-scores based on neuropsychological assessment (lasting up to 40 min) evaluating (global cognitive functions, memory, attention, psychomotor functions, executive functions, visuospatial functions, language, depressive symptoms, and activities of daily living) Only if there are no changes in z-score, we will asses change on a level of individual tests.

  2. Magnetic resonance imaging

    Time frame: Change from baseline immediately after completion of stimulation protocol and one month after completion of stimulation protocol

    Investigator will record high resolution structural T1-weighted (MPRAGE) images, functional T2* weighted multiband EPI sequences, and DTI measurement. The total time spent in the scanner will be approximately 60 min

Other outcomes

  1. Memory task in virtual reality performance - the accuracy

    Time frame: Change from baseline immediately after completion of stimulation protocol and one month after completion of stimulation protocol

  2. Memory task in virtual reality performance - The time to accomplish different difficulty levels

    Time frame: Change from baseline immediately after completion of stimulation protocol and one month after completion of stimulation protocol

  3. Memory task in virtual reality performance - The trajectories needed for completion of different difficulty levels

    Time frame: Change from baseline immediately after completion of stimulation protocol and one month after completion of stimulation protocol

  4. Visual working memory task accuracy

    Time frame: Change from baseline immediately after completion of stimulation protocol and one month after completion of stimulation protocol

    Task will be presented on a computer and subject will respond by YES-NO buttons. Only if there are no differences in task accuracy, we will measure task reaction times (e.g. due to the roof effect).

Sponsors and collaborators

Lead sponsor

Masaryk University

Other

Collaborators

  • St. Anne's University Hospital Brno, Czech Republic

Registry information

Official study title

The Effect of Transcranial Direct Current Stimulation on Visual Attention in Mild Cognitive Impairment - a Combined MRI and Non-invasive Brain Stimulation Study

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jun 4, 2019
Registry last updated
Mar 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.