Stability of rTMS on Cognition and Brain Networks on Healthy Subjects.
NCT01861639 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 158
Last updated 2016-04-19
Summary
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.
Conditions
- Healthy
Interventions
- DEVICE
-
ineffective rTMS
A 20Hz repetitive transcranial magnetic stimulation (rTMS) will be applied for 900 ms with an intensity of 90% of motor threshold. Active stimulation will be applied on the L-DLPFC compared to an ineffective stimulation.
- DEVICE
-
active TBS
A continuous Theta-Burst Stimulation (cTBS) protocol will be applied over the L-DLPFC. Three stimuli at 50Hz, 80% of individual Motor Threshold will be repeated every 200ms for 40sec
- DEVICE
-
Sham TBS
A Sham stimulation will be applied over the L-DLPFC. a placebo coil will be used.
- DEVICE
-
fMRI
Functional MRI data will be acquired during the performance of the memory task. Functional data will be acquired with a blood oxygenation level dependant (BOLD) contrast sensitive gradient echo, T2\*-weighted echo-planar imaging sequence
- DEVICE
-
EEG
EEG will be coupled with task performance in an event-related manner to be able to isolate brain activity of each type of stimuli presented. EEG imaging data will be acquired during the memory task.
- DEVICE
-
Effective rTMS
A 20Hz repetitive transcranial magnetic stimulation (rTMS) will be applied for 900 ms with an intensity of 90% of motor threshold. Active stimulation will be applied on the L-DLPFC compared to an effective stimulation.
Sponsors & Collaborators
-
Qualissima
lead OTHER
Principal Investigators
-
David Bartrés-Faz · Institut d'Investigacions Biomèdiques August Pi i Sunyer
-
Christine Audebert · CIC-CPCET
Study Design
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 40 Years
- Sex
- MALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2013-05-31
- Primary Completion
- 2015-12-31
- Completion
- 2015-12-31
Countries
- France
- Spain
Study Locations
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