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

NCT ID: NCT03974087

Last Updated: 2023-03-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-19
• Study Completion Date: 2022-12-30

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

Conditions

Mild Cognitive Impairment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

MCI patients with real transcranial direct current stimulation

Patients will receive 2mA stimulation in 10 consecutive sessions.

Group Type: ACTIVE_COMPARATOR

Transcranial Direct Current Stimulation (tDCS)

Intervention Type: DEVICE

2mA stimulation for 20 minutes

MCI patients with sham transcranial direct current stimulation

Patients will receive sham stimulation in 10 consecutive sessions.

Group Type: SHAM_COMPARATOR

Transcranial Direct Current Stimulation (tDCS)

Intervention Type: DEVICE

2mA stimulation for 20 minutes

Interventions

Transcranial Direct Current Stimulation (tDCS)

2mA stimulation for 20 minutes

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

St. Anne's University Hospital Brno, Czech Republic

OTHER

Sponsor Role: collaborator

Masaryk University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lubomira Anderková, PhD

Role: PRINCIPAL_INVESTIGATOR

Ceitec, Masaryk University

Locations

Ceitec, Masaryk University

Brno, , Czechia

Countries

Czechia

Other Identifiers

NV18-04-00256

Identifier Type: -

Identifier Source: org_study_id