Back to resultsModulation of Cognition and Brain Connectivity by Noninvasive Brain Stimulation in Patients With Mild Cognitive Impairment Due to Alzheimer's Disease (LUSTR)
Primary Purpose
Mild Cognitive Impairment
Status
Unknown status
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
Transcranial magnetic stimulation
Sponsored by
About this trial
This is an interventional supportive care trial for Mild Cognitive Impairment
Eligibility 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
Sites / Locations
- Ceitec Masaryk UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
Active Comparator: MCI patients with real iTBS
Sham Comparator: MCI patients with sham iTBS
Arm Description
Patients will receive real iTBS in a week-long sessions.
Patients will receive sham iTBS in a week-long sessions.
Outcomes
Primary Outcome Measures
Visual-attention task accuracy and reaction times
Stroop task will be presented in fMRI
Secondary Outcome Measures
Resting state measurement
The effect of stimulation on the resting state networks will be studied using fMRI measurement.
Full Information
NCT ID
NCT04012346
First Posted
June 28, 2019
Last Updated
July 5, 2019
Sponsor
Masaryk University
Collaborators
St. Anne's University Hospital Brno, Czech Republic
1. Study Identification
Unique Protocol Identification Number
NCT04012346
Brief Title
Modulation of Cognition and Brain Connectivity by Noninvasive Brain Stimulation in Patients With Mild Cognitive Impairment Due to Alzheimer's Disease
Acronym
LUSTR
Official Title
Modulation of Cognition and Brain Connectivity by Noninvasive Brain Stimulation in Patients With Mild Cognitive Impairment Due to Alzheimer's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
April 30, 2018 (Actual)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Masaryk University
Collaborators
St. Anne's University Hospital Brno, Czech Republic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Active Comparator: MCI patients with real iTBS
Arm Type
Active Comparator
Arm Description
Patients will receive real iTBS in a week-long sessions.
Arm Title
Sham Comparator: MCI patients with sham iTBS
Arm Type
Sham Comparator
Arm Description
Patients will receive sham iTBS in a week-long sessions.
Intervention Type
Device
Intervention Name(s)
Transcranial magnetic stimulation
Intervention Description
Transcranial magnetic stimulation device will be used. Short protocol iTBS will be applied.
Primary Outcome Measure Information:
Title
Visual-attention task accuracy and reaction times
Description
Stroop task will be presented in fMRI
Time Frame
On the beginning of the study, after completion of week stimulation a two weeks after completion of stimulation sessions.
Secondary Outcome Measure Information:
Title
Resting state measurement
Description
The effect of stimulation on the resting state networks will be studied using fMRI measurement.
Time Frame
On the beginning of the study, after completion of week stimulation a two weeks after completion of stimulation sessions.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lubomira Anderkova, PhD
Phone
+420 549 497 766
Email
lubomira.anderkova@ceitec.muni.cz
Facility Information:
Facility Name
Ceitec Masaryk University
City
Brno
ZIP/Postal Code
62500
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lubomira Anderkova, PhD
Phone
+420 549 497 766
12. IPD Sharing Statement
Learn more about this trial
Modulation of Cognition and Brain Connectivity by Noninvasive Brain Stimulation in Patients With Mild Cognitive Impairment Due to Alzheimer's Disease
We'll reach out to this number within 24 hrs