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出境医 / 临床实验 / 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

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.

Condition or disease Intervention/treatment Phase
Mild Cognitive Impairment Device: Transcranial Direct Current Stimulation (tDCS) Not Applicable

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 Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
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
Actual Study Start Date : February 19, 2020
Estimated Primary Completion Date : May 15, 2021
Estimated Study Completion Date : September 30, 2021
Arms and Interventions
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
Outcome Measures
Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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).


Eligibility Criteria
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Ages Eligible for Study:   60 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

Contacts
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Contact: Lubomira Anderková, PhD +420 549 497 766 lubomira.anderkova@ceitec.muni.cz
Contact: Monika Pupíková, Mgr. +420 549 498 313 pupikovam@gmail.com

Locations
Layout table for location information
Czechia
Ceitec, Masaryk University Recruiting
Brno, Czechia, 61300
Contact: Monika Pupíková    +420549498313    monika.pupikova@ceitec.muni.cz   
Sponsors and Collaborators
Masaryk University
St. Anne's University Hospital Brno, Czech Republic
Investigators
Layout table for investigator information
Principal Investigator: Lubomira Anderková, PhD Ceitec, Masaryk University
Tracking Information
First Submitted Date  ICMJE May 10, 2019
First Posted Date  ICMJE June 4, 2019
Last Update Posted Date February 20, 2020
Actual Study Start Date  ICMJE February 19, 2020
Estimated Primary Completion Date May 15, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 3, 2019) 		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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 3, 2019)
  • 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.
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: June 3, 2019)
  • 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 ]
  • 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 ]
  • 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 ]
  • 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).
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE The Effect of Transcranial Direct Current Stimulation on Visual Attention in Mild Cognitive Impairment
Official Title  ICMJE The Effect of Transcranial Direct Current Stimulation on Visual Attention in Mild Cognitive Impairment - a Combined MRI and Non-invasive Brain Stimulation Study
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE Mild Cognitive Impairment
Intervention  ICMJE Device: Transcranial Direct Current Stimulation (tDCS)
2mA stimulation for 20 minutes
Study Arms  ICMJE
  • Active Comparator: MCI patients with real transcranial direct current stimulation
    Patients will receive 2mA stimulation in 10 consecutive sessions.
    Intervention: Device: Transcranial Direct Current Stimulation (tDCS)
  • Sham Comparator: MCI patients with sham transcranial direct current stimulation
    Patients will receive sham stimulation in 10 consecutive sessions.
    Intervention: Device: Transcranial Direct Current Stimulation (tDCS)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 3, 2019) 		40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 30, 2021
Estimated Primary Completion Date May 15, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Lubomira Anderková, PhD +420 549 497 766 lubomira.anderkova@ceitec.muni.cz
Contact: Monika Pupíková, Mgr. +420 549 498 313 pupikovam@gmail.com
Listed Location Countries  ICMJE Czechia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03974087
Other Study ID Numbers  ICMJE NV18-04-00256
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Masaryk University
Study Sponsor  ICMJE Masaryk University
Collaborators  ICMJE St. Anne's University Hospital Brno, Czech Republic
Investigators  ICMJE
Principal Investigator: Lubomira Anderková, PhD Ceitec, Masaryk University
PRS Account Masaryk University
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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