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

NCT03974087 | Completed

• 1 other identifier: NV18-04-00256
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Mild Cognitive Impairment

Keywords

Mild Cognitive Impairment; Transcranial direct current stimulation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Psychological assessment - z-score computed from multiple psychological domains

  Change from baseline immediately after one month from completion of stimulation protocol

• Magnetic resonance imaging

  Change from baseline immediately after completion of stimulation protocol and one month after completion of stimulation protocol

Other Outcomes (4)

• 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

• 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

• 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

Study Arms (2)

MCI patients with real transcranial direct current stimulation

ACTIVE COMPARATOR

Patients will receive 2mA stimulation in 10 consecutive sessions.

Device: Transcranial Direct Current Stimulation (tDCS)

MCI patients with sham transcranial direct current stimulation

SHAM COMPARATOR

Patients will receive sham stimulation in 10 consecutive sessions.

Device: Transcranial Direct Current Stimulation (tDCS)

Interventions

Transcranial Direct Current Stimulation (tDCS) DEVICE

2mA stimulation for 20 minutes

MCI patients with real transcranial direct current stimulation; MCI patients with sham transcranial direct current stimulation

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• amnestic single or multi-domain mild cognitive impairment patients in accordance with diagnostic criteria (Albert et al., 2011)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Masaryk University: lead
• St. Anne's University Hospital Brno, Czech Republic: collaborator

Study Sites (1)

Ceitec, Masaryk University

Brno, 61300, Czechia

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Lubomira Anderková, PhD

  Ceitec, Masaryk University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2019
• First Posted: June 4, 2019
• Study Start: February 19, 2020
• Primary Completion: October 30, 2022
• Study Completion: December 30, 2022
• Last Updated: March 15, 2023

Record last verified: 2021-09

Locations

CZ (1)