Modulation of Cognition and Brain Connectivity by Noninvasive Brain Stimulation in Patients With Mild Cognitive Impairment Due to Alzheimer's Disease
LUSTR
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 30, 2018
CompletedFirst Submitted
Initial submission to the registry
June 28, 2019
CompletedFirst Posted
Study publicly available on registry
July 9, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedJuly 9, 2019
July 1, 2019
1.6 years
June 28, 2019
July 5, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Resting state measurement
On the beginning of the study, after completion of week stimulation a two weeks after completion of stimulation sessions.
Study Arms (2)
Active Comparator: MCI patients with real iTBS
ACTIVE COMPARATORPatients will receive real iTBS in a week-long sessions.
Sham Comparator: MCI patients with sham iTBS
SHAM COMPARATORPatients will receive sham iTBS in a week-long sessions.
Interventions
Transcranial magnetic stimulation device will be used. Short protocol iTBS will be applied.
Eligibility Criteria
You may qualify if:
- amnestic single or multi-domain mild cognitive impairment patients in accordance with diagnostic criteria (Albert et al., 2011)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ceitec Masaryk University
Brno, 62500, Czechia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 28, 2019
First Posted
July 9, 2019
Study Start
April 30, 2018
Primary Completion
December 1, 2019
Study Completion
December 1, 2019
Last Updated
July 9, 2019
Record last verified: 2019-07