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

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

Study Description
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.
Study Design
Layout table for study information
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
Arms and Interventions
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.
Outcome Measures
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.


Eligibility Criteria
Layout table for eligibility information
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
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Lubomira Anderkova, PhD +420 549 497 766 lubomira.anderkova@ceitec.muni.cz

Locations
Layout table for location information
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
Tracking Information
First Submitted Date  ICMJE June 28, 2019
First Posted Date  ICMJE July 9, 2019
Last Update Posted Date July 9, 2019
Actual Study Start Date  ICMJE April 30, 2018
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 5, 2019) 		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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 5, 2019) 		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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Modulation of Cognition and Brain Connectivity by Noninvasive Brain Stimulation in Patients With Mild Cognitive Impairment Due to Alzheimer's Disease
Official Title  ICMJE Modulation of Cognition and Brain Connectivity by Noninvasive Brain Stimulation in Patients With Mild Cognitive Impairment Due to Alzheimer's Disease
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Condition  ICMJE Mild Cognitive Impairment
Intervention  ICMJE Device: Transcranial magnetic stimulation
Transcranial magnetic stimulation device will be used. Short protocol iTBS will be applied.
Study Arms  ICMJE
  • Active Comparator: Active Comparator: MCI patients with real iTBS
    Patients will receive real iTBS in a week-long sessions.
    Intervention: Device: Transcranial magnetic stimulation
  • Sham Comparator: Sham Comparator: MCI patients with sham iTBS
    Patients will receive sham iTBS in a week-long sessions.
    Intervention: Device: Transcranial magnetic stimulation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 5, 2019) 		20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Lubomira Anderkova, PhD +420 549 497 766 lubomira.anderkova@ceitec.muni.cz
Listed Location Countries  ICMJE Czechia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04012346
Other Study ID Numbers  ICMJE NV16-31868A
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Masaryk University
Study Sponsor  ICMJE Masaryk University
Collaborators  ICMJE St. Anne's University Hospital Brno, Czech Republic
Investigators  ICMJE Not Provided
PRS Account Masaryk University
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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