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

Mild Cognitive Impairment Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03974087
• Other study ID #: NV18-04-00256
• Status: Completed
• Phase: N/A
• Start date: February 19, 2020
• Est. completion date: December 30, 2022

Study information

• Verified date: September 2021
• Source: Masaryk University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: December 30, 2022
• Est. primary completion date: October 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Mild Cognitive Impairment

Intervention

Device:
• Transcranial Direct Current Stimulation (tDCS)
2mA stimulation for 20 minutes

Locations

Country	Name	City	State
Czechia	Ceitec, Masaryk University	Brno

Sponsors (2)

Lead Sponsor	Collaborator
Masaryk University	St. Anne's University Hospital Brno, Czech Republic

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Primary	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	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
Secondary	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