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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01861639
• Other study ID #: WP1P003
• Status: Terminated
• Phase: N/A
• First received: May 16, 2013
• Last updated: April 18, 2016
• Start date: May 2013
• Est. completion date: December 2015

Study information

• Verified date: April 2016
• Source: Qualissima
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación ClínicaFrance: Committee for the Protection of PersonnesFrance: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 158
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• 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.

• The subject is covered by a social insurance.

• The subject has provided written informed consent.

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Healthy

Intervention

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

Locations

Country	Name	City	State
France	Cic-Cpcet	Marseille
Spain	IDIBAPS	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Qualissima

Countries where clinical trial is conducted

France,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	CANTAB task	CANTAB / Rapid Visual Information Processing (RVIP); CANTAB / Spatial Working Memory (SWM); CANTAB / Paired Associates Learning (PAL)	Day 1 and Day 15	No
Secondary	Gene expression	Interest genes expression will be investigated depending on the impact of TMS on behavioral and functional brain responses.	Day 1	No
Secondary	Imaging	Functional MRI (Barcelona): modifications will be highlighted by changes in Blood Oxydation level Dependence (BOLD)signal patterns; EEG (Marseille): modifications will be highlighted by changes in EEG markers	Day1 and Day 15	No