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

NCT01861639 | Terminated

• 1 other identifier: WP1P003
• Study Type: interventional
• Target: 158
• Locations: 2 countries
• Sites: 2

Brief 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

Outcome Measures

Primary Outcomes (1)

• Outputs of the memory task

  outputs: number of correct answers during the retrieval event-related task (Hit rate) and the rate of false recognition of novel pictures (False Alarms rate).

  up to Day 15

Secondary Outcomes (3)

• CANTAB task

  Day 1 and Day 15

• Gene expression

  Day 1

• Imaging

  Day1 and Day 15

Study Arms (8)

ineffective rTMS - Active TBS - fMRI

EXPERIMENTAL

Device: ineffective rTMS; Device: active TBS; Device: fMRI

Effective rTMS - Active TBS - fMRI

EXPERIMENTAL

Device: active TBS; Device: fMRI; Device: Effective rTMS

ineffective rTMS - Sham TBS - fMRI

SHAM COMPARATOR

Device: ineffective rTMS; Device: Sham TBS; Device: fMRI

Effective rTMS - Sham TBS - fMRI

SHAM COMPARATOR

Device: Sham TBS; Device: fMRI; Device: Effective rTMS

ineffective rTMS - Active TBS - EEG

EXPERIMENTAL

Device: ineffective rTMS; Device: active TBS; Device: EEG

Effective rTMS - Active TBS - EEG

EXPERIMENTAL

Device: active TBS; Device: EEG; Device: Effective rTMS

ineffective rTMS - Sham TBS - EEG

SHAM COMPARATOR

Device: ineffective rTMS; Device: Sham TBS; Device: EEG

Effective rTMS - Sham TBS - EEG

SHAM COMPARATOR

Device: Sham TBS; Device: EEG; Device: Effective rTMS

Interventions

ineffective rTMS DEVICE

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.

ineffective rTMS - Active TBS - EEG; ineffective rTMS - Active TBS - fMRI; ineffective rTMS - Sham TBS - EEG; ineffective rTMS - Sham TBS - fMRI

active TBS DEVICE

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

Effective rTMS - Active TBS - EEG; Effective rTMS - Active TBS - fMRI; ineffective rTMS - Active TBS - EEG; ineffective rTMS - Active TBS - fMRI

Sham TBS DEVICE

A Sham stimulation will be applied over the L-DLPFC. a placebo coil will be used.

Effective rTMS - Sham TBS - EEG; Effective rTMS - Sham TBS - fMRI; ineffective rTMS - Sham TBS - EEG; ineffective rTMS - Sham TBS - fMRI

fMRI DEVICE

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

Effective rTMS - Active TBS - fMRI; Effective rTMS - Sham TBS - fMRI; ineffective rTMS - Active TBS - fMRI; ineffective rTMS - Sham TBS - fMRI

EEG DEVICE

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.

Effective rTMS - Active TBS - EEG; Effective rTMS - Sham TBS - EEG; ineffective rTMS - Active TBS - EEG; ineffective rTMS - Sham TBS - EEG

Effective rTMS DEVICE

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.

Effective rTMS - Active TBS - EEG; Effective rTMS - Active TBS - fMRI; Effective rTMS - Sham TBS - EEG; Effective rTMS - Sham TBS - fMRI

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male subjects aged between 18 and 40 years-old inclusive.
• Education level: at least secondary.
• Right-handed (Edinburgh Handedness Inventory).
• The subjects are in good health on the basis of the medical interview (medical history, symptoms), the physical examination and vital signs.
• No history of psychiatric disorders (assessed by Structured Clinical Interview for DSM IV Disorders (SCID) for Barcelona and by the Mini International Neuropsychiatric Interview (MINI) for Marseille).
• No history of neurological disorders
• No history of concussion (cranial or facial trauma) without or with loss of consciousness.
• Subject without history of brain disease (severe brain trauma, stroke, cerebral tumor...).
• Subject without lesion on MRI.
• Subject without abnormal electrical activities on standard clinical EEG.
• No history of drug or alcohol abuse.
• No smoker or ≤ 5 cg/ day.
• The subject can complete the neuropsychological test battery during the training session.
• Subject without contraindication to MRI.
• The subject is able to read and understand the Information Form and comply with the protocol instructions and restrictions.

You may not qualify if:

• History or presence of psychiatric illness (Psychiatric interview).
• History or presence of neurologic illness.
• The subject, in the opinion of the investigator, is unlikely to comply with the study protocol or is unsuitable for any other reason.
• The subject participates in another clinical trial or is still being within a washout period of 1 month since last taking of a previous clinical trial, or subjects who have received more than 4500 Euros in the previous 12 months for participating in clinical trials.
• Presence of metallic objects within the body.
• Subjects with pacemaker.
• Claustrophobia.
• Individual and familial history of epileptic seizure.
• Any medication listed (see annexe) in the safety guidelines published by the Safety of TMS Consensus Group (Rossi et al., 2009) will be forbidden.
• Subject with a correct hit rate during the retrieval session of the memory task

Sponsors & Collaborators

• Qualissima: lead

Study Sites (2)

Cic-Cpcet

Marseille, 13005, France

Location

IDIBAPS

Barcelona, 08036, Spain

Location

MeSH Terms

Interventions

Magnetic Resonance Imaging; Electroencephalography

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Neurological; Electrodiagnosis

Study Officials

• David Bartrés-Faz

  Institut d'Investigacions Biomèdiques August Pi i Sunyer

  PRINCIPAL INVESTIGATOR

• Christine Audebert

  CIC-CPCET

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2013
• First Posted: May 23, 2013
• Study Start: May 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: April 19, 2016

Record last verified: 2016-04

Locations

FR (1); ES (1)