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

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

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.

Study Overview

• Status: Completed
• Conditions: Mild Cognitive Impairment
• Intervention / Treatment: Device: Transcranial Direct Current Stimulation (tDCS)

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Czechia
  • Brno, Czechia, 61300
    • Ceitec, Masaryk University

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:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: MCI patients with real transcranial direct current stimulation; Patients will receive 2mA stimulation in 10 consecutive sessions.	Device: Transcranial Direct Current Stimulation (tDCS); 2mA stimulation for 20 minutes
Sham Comparator: MCI patients with sham transcranial direct current stimulation; Patients will receive sham stimulation in 10 consecutive sessions.	Device: Transcranial Direct Current Stimulation (tDCS); 2mA stimulation for 20 minutes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual-attention task accuracy	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).	Change from baseline immediately after completion of stimulation protocol and one month after completion of stimulation protocol

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Psychological assessment - z-score computed from multiple psychological domains	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.	Change from baseline immediately after one month from completion of stimulation protocol
Magnetic resonance imaging	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	Change from baseline immediately after completion of stimulation protocol and one month after completion of stimulation protocol

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Memory task in virtual reality performance - the accuracy		Change from baseline immediately after completion of stimulation protocol and one month after completion of stimulation protocol
Memory task in virtual reality performance - The time to accomplish different difficulty levels		Change from baseline immediately after completion of stimulation protocol and one month after completion of stimulation protocol
Memory task in virtual reality performance - The trajectories needed for completion of different difficulty levels		Change from baseline immediately after completion of stimulation protocol and one month after completion of stimulation protocol
Visual working memory task accuracy	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).	Change from baseline immediately after completion of stimulation protocol and one month after completion of stimulation protocol

Collaborators and Investigators

• Sponsor: Masaryk University
• Collaborators: St. Anne's University Hospital Brno, Czech Republic
• Investigators: Principal Investigator: Lubomira Anderková, PhD, Ceitec, Masaryk University

Study record dates

Study Major Dates

• Study Start (Actual): February 19, 2020
• Primary Completion (Actual): October 30, 2022
• Study Completion (Actual): December 30, 2022

Study Registration Dates

• First Submitted: May 10, 2019
• First Submitted That Met QC Criteria: June 3, 2019
• First Posted (Actual): June 4, 2019

Study Record Updates

• Last Update Posted (Actual): March 15, 2023
• Last Update Submitted That Met QC Criteria: March 14, 2023
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Mild Cognitive Impairment; Transcranial direct current stimulation
• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: NV18-04-00256

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No