- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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
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.
Panoramica dello studio
Stato
Condizioni
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Sperimentale: ineffective rTMS - Active TBS - fMRI
|
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.
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
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
|
Sperimentale: Effective rTMS - Active TBS - fMRI
|
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
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
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.
|
Comparatore fittizio: ineffective rTMS - Sham TBS - fMRI
|
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.
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
A Sham stimulation will be applied over the L-DLPFC.
a placebo coil will be used.
|
Comparatore fittizio: Effective rTMS - Sham TBS - 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
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.
A Sham stimulation will be applied over the L-DLPFC.
a placebo coil will be used.
|
Sperimentale: ineffective rTMS - Active TBS - EEG
|
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.
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
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.
|
Sperimentale: Effective rTMS - Active TBS - EEG
|
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
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.
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.
|
Comparatore fittizio: ineffective rTMS - Sham TBS - EEG
|
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.
A Sham stimulation will be applied over the L-DLPFC.
a placebo coil will be used.
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.
|
Comparatore fittizio: Effective rTMS - Sham TBS - EEG
|
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.
A Sham stimulation will be applied over the L-DLPFC.
a placebo coil will be used.
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.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Outputs of the memory task
Lasso di tempo: up to Day 15
|
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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
CANTAB task
Lasso di tempo: Day 1 and Day 15
|
|
Day 1 and Day 15
|
Gene expression
Lasso di tempo: Day 1
|
Interest genes expression will be investigated depending on the impact of TMS on behavioral and functional brain responses.
|
Day 1
|
Imaging
Lasso di tempo: Day1 and Day 15
|
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
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Christine Audebert, Cic-Cpcet
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- WP1P003
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
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