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

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ClinicalTrials.gov Identifier: NCT03974087
Recruitment Status : Not yet recruiting
First Posted : June 4, 2019
Last Update Posted : June 4, 2019
Sponsor:
Collaborator:
St. Anne's University Hospital Brno, Czech Republic
Information provided by (Responsible Party):
Masaryk University

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

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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
Estimated Study Start Date : July 15, 2019
Estimated Primary Completion Date : December 15, 2019
Estimated Study Completion Date : September 30, 2020

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




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).



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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03974087


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

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

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Responsible Party: Masaryk University
ClinicalTrials.gov Identifier: NCT03974087     History of Changes
Other Study ID Numbers: NV18-04-00256
First Posted: June 4, 2019    Key Record Dates
Last Update Posted: June 4, 2019
Last Verified: May 2019

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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
Keywords provided by Masaryk University:
Mild Cognitive Impairment
Transcranial direct current stimulation
Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders