Healthy Clinical Trial
Official title:
Influence of Repetitive Transcranial Magnetic Stimulation (rTMS) Challenge on Cognitive and Functional Magnetic Resonance Imaging Markers in Healthy Subjects
Episodic and working memory processes are the most affected cognitive domains in Alzheimer's
Disease (AD) and its early stage, Mild Cognitive Impairment (MCI). Transcranial Magnetic
Stimulation (TMS) is a unique tool to interfere with cognitive processes by inducing
"virtual and transient lesions", mimicking those observed in MCI. It has proven repeatedly
its capacity to interfere with encoding-retrieval memory task. However, to date, only few
imaging data exist on the cerebral pathways involved in encoding memory task. Moreover, the
stability of TMS effects over time remains to be investigated. If proven to be a stable
interfering challenge, TMS could be used to investigate the potential restoring effect of
new medication in AD.
The study is the pilot study of a larger clinical trial which aims to prove the utility of
rTMS as a potential model for prediction of clinical efficacy using a combination of
cognitive and neuroimaging endpoints.
Episodic and working memory processes are the most affected cognitive domains in Alzheimer's
Disease (AD) and its early stage, Mild Cognitive Impairment (MCI). Transcranial Magnetic
Stimulation (TMS) is a unique tool to interfere with cognitive processes by inducing
"virtual and transient lesions", mimicking those observed in MCI. It has proven repeatedly
its capacity to interfere with encoding-retrieval memory task. However, to date, only few
imaging data exist on the cerebral pathways involved in encoding memory task. Moreover, the
stability of TMS effects over time remains to be investigated. If proven to be a stable
interfering challenge, TMS could be used to investigate the potential restoring effect of
new medication in AD.
The study is the pilot study of a larger clinical trial which aims to prove the utility of
rTMS as a potential model for prediction of clinical efficacy using a combination of
cognitive and neuroimaging endpoints.
This pilot study specifically aims:
- to determine the cerebral region to stimulate using functional neuronavigation,
- to evaluate the effects of rTMS on behavioral and functional imaging data (functional
Magnetic Resonance Imaging, fMRI)
- to investigate the stability of the TMS interfering effects by replicating the
experimental day up to 4 times.
The study is composed of two parts:
- Part A: on Day 1, the subjects will perform the episodic memory task in the MRI scanner
to determine individual main activations. The mean activation peak obtained by a group
analysis will be used as the target coordinates during the part B. Two weeks later, on
Day 2, the subjects will repeat the episodic memory task in the MRI scanner. The BOLD
signal changes will be compared between Day 1 and Day 2 to investigate the stability of
the activations elicited by the memory task.
- Part B: subjects will randomly be assigned to Group 1 or 2.
- GROUP 1: The subjects will come on 4 different days. On each day, the subjects
will perform the episodic memory task while being actively stimulated using rTMS
over L-DLPFC and Vertex (control region) in random order and will undergo an fMRI
session on Day 1 and Day 2. Later, they will undergo another set of behavioral
tasks from the CANTAB battery and will be stimulated by rTMS using a placebo coil.
- GROUP 2: The subjects will come on 4 different days. On each day, the subjects
will perform the episodic memory task while being actively stimulated using rTMS
over L-DLPFC and Vertex (control region) in random order and will undergo an fMRI
session on Day 1 and Day 2. Later, they will undergo another set of behavioral
tasks from the CANTAB battery and will be stimulated by rTMS using an active coil.
Total expected number of subjects:
34 subjects for the Parts A and B PART A: 10 subjects PART B: 24 subjects (12 per group)
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science
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