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

Mild Cognitive Impairment Clinical Trial

— LUSTR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04012346
• Other study ID #: NV16-31868A
• Status: Recruiting
• Phase: N/A
• Start date: April 30, 2018
• Est. completion date: December 2019

Study information

• Verified date: July 2019
• Source: Masaryk University
• Contact: Lubomira Anderkova, PhD
• Phone: +420 549 497 766
• Email: lubomira.anderkova[@]ceitec.muni.cz
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Cognitive Dysfunction
• Mild Cognitive Impairment

Intervention

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

Locations

Country	Name	City	State
Czechia	Ceitec Masaryk University	Brno

Sponsors (2)

Lead Sponsor	Collaborator
Masaryk University	St. Anne's University Hospital Brno, Czech Republic

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual-attention task accuracy and reaction times	Stroop task will be presented in fMRI	On the beginning of the study, after completion of week stimulation a two weeks after completion of stimulation sessions.
Secondary	Resting state measurement	The effect of stimulation on the resting state networks will be studied using fMRI measurement.	On the beginning of the study, after completion of week stimulation a two weeks after completion of stimulation sessions.