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Trial record 6 of 27 for:    transcranial magnetic stimulation | Mild Cognitive Impairment

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

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ClinicalTrials.gov Identifier: NCT04012346
Recruitment Status : Recruiting
First Posted : July 9, 2019
Last Update Posted : July 9, 2019
Sponsor:
Collaborator:
St. Anne's University Hospital Brno, Czech Republic
Information provided by (Responsible Party):
Masaryk University

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.

Condition or disease Intervention/treatment Phase
Mild Cognitive Impairment Device: Transcranial magnetic stimulation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: Modulation of Cognition and Brain Connectivity by Noninvasive Brain Stimulation in Patients With Mild Cognitive Impairment Due to Alzheimer's Disease
Actual Study Start Date : April 30, 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Active Comparator: MCI patients with real iTBS
Patients will receive real iTBS in a week-long sessions.
Device: Transcranial magnetic stimulation
Transcranial magnetic stimulation device will be used. Short protocol iTBS will be applied.

Sham Comparator: Sham Comparator: MCI patients with sham iTBS
Patients will receive sham iTBS in a week-long sessions.
Device: Transcranial magnetic stimulation
Transcranial magnetic stimulation device will be used. Short protocol iTBS will be applied.




Primary Outcome Measures :
  1. Visual-attention task accuracy and reaction times [ Time Frame: On 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 Outcome Measures :
  1. Resting state measurement [ Time Frame: On 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04012346


Contacts
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Contact: Lubomira Anderkova, PhD +420 549 497 766 lubomira.anderkova@ceitec.muni.cz

Locations
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Czechia
Ceitec Masaryk University Recruiting
Brno, Czechia, 62500
Contact: Lubomira Anderkova, PhD    +420 549 497 766      
Sponsors and Collaborators
Masaryk University
St. Anne's University Hospital Brno, Czech Republic
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Responsible Party: Masaryk University
ClinicalTrials.gov Identifier: NCT04012346    
Other Study ID Numbers: NV16-31868A
First Posted: July 9, 2019    Key Record Dates
Last Update Posted: July 9, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cognitive Dysfunction
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cognition Disorders