LUSTRModulation of Cognition and Brain Connectivity by Noninvasive Brain Stimulation in Patients With Mild Cognitive Impairment Due to Alzheimer's Disease
Transcranial magnetic stimulation
Mental Disorders+1
+ Cognition Disorders
+ Neurocognitive Disorders
Supportive Care Study
Summary
Study start date: April 30, 2018
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.20 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Supportive Care Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 60 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
Active ComparatorGroup II
ShamStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location