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Modulation of Cognition and Brain Connectivity by Noninvasive Brain Stimulation in Patients With Mild Cognitive Impairment Due to Alzheimer's Disease

Modulation of Cognition and Brain Connectivity by Noninvasive Brain Stimulation in Patients With Mild Cognitive Impairment Due to Alzheimer's Disease

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04012346
Acronym
LUSTR
Enrollment
20
Registered
2019-07-09
Start date
2018-04-30
Completion date
2019-12-31
Last updated
2019-07-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mild Cognitive Impairment

Brief summary

Alzheimer's disease (AD) has a detrimental impact on cognitive functions. Based on pilot studies results in patients with neurodegenerative brain diseases the investigators aim for promoting the brain plasticity and improving cognition by noninvasive brain stimulation (NIBS) in healthy young, healthy aged and subjects with mild cognitive impairment due to AD. Mild cognitive impairment (MCI) is an intermediate stage between the expected cognitive decline of normal aging and the more-serious decline of dementia. Different new brain targets, cognitive tasks and stimulation protocols will be tested and optimized for specific subject groups. Design of a functional MRI (fMRI) - repetitive transcranial magnetic stimulation (rTMS) - fMRI study will enable us to explore and identify effect of age, presence of the disease and genetic risk factor (APOE4) on repetitive transcranial magnetic stimulation (rTMS)-induced changes in cognition and related brain connectivity/activations. The study results will improve our understanding of healthy and pathological brain aging and will provide novel information about the usefulness of NIBS in specific subject groups. These results will have an important impact on future non-pharmacological treatment strategies.

Detailed description

Intensified intermittent theta-burst stimulation (iTBS) protocol will be applied in the MCI study group. A two-parallel-group, randomized, placebo controlled design will be used. Ten MCI subjects will be stimulated in a week-long therapeutical sessions. Other ten MCI subjects will be stimulated with the same protocol using sham stimulation. The investigators will study the change in subjects immediately after and again at a two-weeks follow-up visit after the end of the last stimulation session.

Interventions

DEVICETranscranial magnetic stimulation

Transcranial magnetic stimulation device will be used. Short protocol iTBS will be applied.

Sponsors

St. Anne's University Hospital Brno, Czech Republic
CollaboratorOTHER
Masaryk University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Visual-attention task accuracy and reaction timesOn the beginning of the study, after completion of week stimulation a two weeks after completion of stimulation sessions.Stroop task will be presented in fMRI

Secondary

MeasureTime frameDescription
Resting state measurementOn the beginning of the study, after completion of week stimulation a two weeks after completion of stimulation sessions.The effect of stimulation on the resting state networks will be studied using fMRI measurement.

Countries

Czechia

Contacts

Primary ContactLubomira Anderkova, PhD
lubomira.anderkova@ceitec.muni.cz+420 549 497 766

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026