The Effect of Transcranial Direct Current Stimulation on Visual Attention in Mild Cognitive Impairment
Primary Purpose
Mild Cognitive Impairment
Status
Completed
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
Transcranial Direct Current Stimulation (tDCS)
Sponsored by

About this trial
This is an interventional supportive care trial for Mild Cognitive Impairment focused on measuring Mild Cognitive Impairment, Transcranial direct current stimulation
Eligibility Criteria
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.
Sites / Locations
- Ceitec, Masaryk University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
MCI patients with real transcranial direct current stimulation
MCI patients with sham transcranial direct current stimulation
Arm Description
Patients will receive 2mA stimulation in 10 consecutive sessions.
Patients will receive sham stimulation in 10 consecutive sessions.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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.
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
Full Information
NCT ID
NCT03974087
First Posted
May 10, 2019
Last Updated
March 14, 2023
Sponsor
Masaryk University
Collaborators
St. Anne's University Hospital Brno, Czech Republic
1. Study Identification
Unique Protocol Identification Number
NCT03974087
Brief Title
The Effect of Transcranial Direct Current Stimulation on Visual Attention in Mild Cognitive Impairment
Official Title
The Effect of Transcranial Direct Current Stimulation on Visual Attention in Mild Cognitive Impairment - a Combined MRI and Non-invasive Brain Stimulation Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
February 19, 2020 (Actual)
Primary Completion Date
October 30, 2022 (Actual)
Study Completion Date
December 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Masaryk University
Collaborators
St. Anne's University Hospital Brno, Czech Republic
4. Oversight
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
5. Study Description
Brief Summary
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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment
Keywords
Mild Cognitive Impairment, Transcranial direct current stimulation
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MCI patients with real transcranial direct current stimulation
Arm Type
Active Comparator
Arm Description
Patients will receive 2mA stimulation in 10 consecutive sessions.
Arm Title
MCI patients with sham transcranial direct current stimulation
Arm Type
Sham Comparator
Arm Description
Patients will receive sham stimulation in 10 consecutive sessions.
Intervention Type
Device
Intervention Name(s)
Transcranial Direct Current Stimulation (tDCS)
Intervention Description
2mA stimulation for 20 minutes
Primary Outcome Measure Information:
Title
Visual-attention task accuracy
Description
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).
Time Frame
Change from baseline immediately after completion of stimulation protocol and one month after completion of stimulation protocol
Secondary Outcome Measure Information:
Title
Psychological assessment - z-score computed from multiple psychological domains
Description
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.
Time Frame
Change from baseline immediately after one month from completion of stimulation protocol
Title
Magnetic resonance imaging
Description
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
Time Frame
Change from baseline immediately after completion of stimulation protocol and one month after completion of stimulation protocol
Other Pre-specified Outcome Measures:
Title
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
Title
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
Title
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
Title
Visual working memory task accuracy
Description
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).
Time Frame
Change from baseline immediately after completion of stimulation protocol and one month after completion of stimulation protocol
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lubomira Anderková, PhD
Organizational Affiliation
Ceitec, Masaryk University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ceitec, Masaryk University
City
Brno
ZIP/Postal Code
61300
Country
Czechia
12. IPD Sharing Statement
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The Effect of Transcranial Direct Current Stimulation on Visual Attention in Mild Cognitive Impairment
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