Mild Cognitive ImpairmentNCT03974087
The Effect of Transcranial Direct Current Stimulation on Visual Attention in Mild Cognitive Impairment
A study testing Transcranial Direct Current Stimulation (tDCS) in people with Mild Cognitive Impairment, run by Masaryk University at 1 site in Czechia.
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). Read more about this study
- Who is it for?
- Ages 60 to 85 years
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- Transcranial Direct Current Stimulation (tDCS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteCzechia
- Study dates
- 19 Feb 2020to 30 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- amnestic single or multi-domain mild cognitive impairment patients in accordance with diagnostic criteria (Albert et al., 2011)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Being tested
- Transcranial Direct Current Stimulation (tDCS)
- Keywords
- Mild Cognitive Impairment, Transcranial direct current stimulation
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Direct Current Stimulation (tDCS)Device
2mA stimulation for 20 minutes
| Study group | Role | What they receive |
|---|---|---|
| MCI patients with real transcranial direct current stimulation | Active comparator | Patients will receive 2mA stimulation in 10 consecutive sessions. Receives: 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. Receives: Device: Transcranial Direct Current Stimulation (tDCS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
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.
Measured: Change from baseline immediately after one month from completion of stimulation protocol
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
Measured: Change from baseline immediately after completion of stimulation protocol and one month after completion of stimulation protocol
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2019
- Study start19 Feb 2020
- Primary completion30 Oct 2022
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Masaryk University
- Sponsor type
- University, hospital or other
- Collaborators
- St. Anne's University Hospital Brno, Czech Republic
- Responsible party
- Sponsor
- Investigators
- Lubomira Anderková, PhD, Principal investigator, Ceitec, Masaryk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03974087
- Sponsor's protocol ID
- NV18-04-00256
- Status last verified
- Sep 2021
- First submitted
- 10 May 2019
- Last updated
- 15 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03974087
- Acronym / sponsor ID
- NV18-04-00256
- Conditions
- Mild Cognitive Impairment
- Keywords
- Mild Cognitive Impairment, Transcranial direct current stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Masaryk UniversityUniversity, hospital or other
- Collaborators
- St. Anne's University Hospital Brno, Czech Republic
- Study start
- 19 Feb 2020 (actual)
- Primary completion
- 30 Oct 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 4 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MCI patients with real transcranial direct current stimulation | Active comparator | Device: Transcranial Direct Current Stimulation (tDCS)Patients will receive 2mA stimulation in 10 consecutive sessions. |
| MCI patients with sham transcranial direct current stimulation | Sham comparator | Device: Transcranial Direct Current Stimulation (tDCS)Patients will receive sham stimulation in 10 consecutive sessions. |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- amnestic single or multi-domain mild cognitive impairment patients in accordance with diagnostic criteria (Albert et al., 2011)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial Direct Current Stimulation (tDCS)2mA stimulation for 20 minutes | Device | MCI patients with real transcranial direct current stimulation, MCI patients with sham transcranial direct current stimulation |
Primary outcome
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).
2 secondary outcomes
Psychological assessment - z-score computed from multiple psychological domains
Time frame: Change from baseline immediately after one month from completion of stimulation protocol
Magnetic resonance imaging
Time frame: Change from baseline immediately after completion of stimulation protocol and one month after completion of stimulation protocol
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lubomira Anderková, PhD principal investigator
Ceitec, Masaryk University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Direct Current Stimulation (tDCS) in people with Mild Cognitive Impairment, run by Masaryk University at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual-attention task accuracy (time frame: Change from baseline immediately after completion of stimulation protocol and one month after completion of stimulation protocol). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2023.