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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-30

Study Completion Date

2019-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Mild Cognitive Impairment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Active Comparator: MCI patients with real iTBS

Patients will receive real iTBS in a week-long sessions.

Group Type ACTIVE_COMPARATOR

Transcranial magnetic stimulation

Intervention Type DEVICE

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

Sham Comparator: MCI patients with sham iTBS

Patients will receive sham iTBS in a week-long sessions.

Group Type SHAM_COMPARATOR

Transcranial magnetic stimulation

Intervention Type DEVICE

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

Interventions

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Transcranial magnetic stimulation

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

Intervention Type DEVICE

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

No