NCT01861639

Stability of rTMS on Cognition and Brain Networks on Healthy Subjects.

Effect of Repetitive Transcranial Magnetic Stimulation (rTMS) on Cognition and Brain Networks in Healthy Subjects in 2 Sessions 15 Days Apart

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 158 (actual)
• Sponsor: Qualissima · Academic / Other
• Sex: Male
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2013-05-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2013-05-23
• Last updated: 2016-04-19

Locations

2 sites across 2 countries: France, Spain