- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01369264
The Effect of Repetitive Transcranial Magnetic Stimulation on Brain Activity in Healthy Human Volunteers (ERP)
7 juin 2011 mis à jour par: St. Joseph's Healthcare Hamilton
Evaluation of the Effect of Repetitive Transcranial Magnetic Stimulation (rTMS) on Brain Electrical Activity in Healthy Human Volunteers
The proposed study is designed to determine whether small changes in the positioning of a transcranial magnetic stimulation coil over the frontal parts of the brain cause different patterns of brain activation measured by electroencephalography (EEG) and quantitative EEG (QEEG).
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
A previously recorded MRI will be loaded into Brainsight, a stereotactic neuronavigation system specifically designed to be used with rTMS, and the scalp surface site overlying the centre of Brodmann area 46 in the dorsolateral prefrontal cortex (DLPFC) of both the left and right hemisphere will be identified and marked on a spandex swim cap placed on the subjects head over 31 EEG electrodes (notched to prevent eddy currents) placed at international 10-20 locations .
Three trains of true 10 Hz (110% motor threshold (MT)] rTMS (one train each with duration=2,4, and 8 seconds) and 6 similar trains of sham rTMS (3 of active sham and 3 of inactive sham) will be delivered to the left hemisphere in Brodmann area 46 in random order.
Eyes-closed QEEG power will be recorded across all leads over 10 second "blocks" for 1 minute after each 10 Hz stimulus to determine the distribution and time course of any changes in electrical potential and QEEG spectrum.
The subjects will be asked to rate their mood and anxiety by placing a mark along 100 mm long Visual Analogue Scales for depression and anxiety after each stimulus train.
We will also measure ERPs after 1 Hz stimulation to the right DLPFC (centre of Brodmann area 46).
We will administer three 60-second trains of true 1 Hz rTMS (at 90%, 100% and 110% motor threshold), and six 60-second trains of sham rTMS (3 of "active" sham and 3 of "inactive" sham) with device intensity setting of 10 %, 30% and 50% motor threshold and coil tilted at 90 degrees away form the head.
Part 2 (location testing): Twenty four to 48 hours later, the swim hat will be placed on the subject's head and the neuroanatomical landmarks reconfirmed using Brainsight.
One true train and 1 inactive sham train of 10 Hz rTMS (10 Hz, 110% MT) will be delivered in random order to Brodmann area 46 and two other sites (in Brodmann areas 9 and 10).
The rTMS train duration will be 8 seconds.
The subjects will be asked to rate their mood and anxiety by placing a mark along 100 mm long Visual Analogue Scales for depression and anxiety after each stimulus train.
The same procedure will be done over the right hemisphere using 1 Hz stimulation set at 110% motor threshold.
True rTMS pulses at 1 Hz, or inactive sham rTMS pulses will be delivered in 60 second trains to the 3 sites as described above, but marked over the right DLPFC.
QEEG activity will be recorded for 1 minute after each stimulus train.
The subjects will be asked to rate their mood and anxiety by placing a mark along 100 mm long Visual Analogue Scales for depression and anxiety after each stimulus train.
Diffusion Tensor Imaging: The 15 healthy subjects (18-65 years old) will also undergo diffusion tensor imaging (DTI) along with the MRI, which will add approximately 10 minutes to the MRI procedure.
Following a routine brain imaging protocol whole brain DTI measurements will be conducted in each subject using a single shot spin echo EPI diffusion tensor imaging sequence.
Type d'étude
Interventionnel
Inscription (Réel)
17
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Ontario
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Hamilton, Ontario, Canada, L8N 3K7
- St. Joseph's Healthcare, Centre for Mountain Health Services
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans à 65 ans (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Oui
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- age 18-65
- male or female
Exclusion Criteria:
- uncontrolled physical health problems
- psychiatric illness
- personal and/or family history of epilepsy/seizures
- metal in the head or neck
- recent head injury
- pacemaker
- pregnancy
- alcohol/substance abuse within 3 months
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Science basique
- Répartition: Randomisé
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: True Left High Frequency
True left high frequency repetitive transcranial magnetic stimulation
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10 Hz stimulation will be given at 110% motor threshold for 8 seconds to Brodmann areas 46, 9 and 10 in the left hemisphere.
The coil will be held flat over the skull surface with the coil handle held at approximately 45 degrees to the floor
Autres noms:
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Comparateur placebo: Passive sham left high frequency
Passive sham left high frequency repetitive transcranial magnetic stimulation
|
10 Hz stimulation will be given at 110% motor threshold for 8 seconds to Brodmann areas 46, 9 and 10 in the left hemisphere.
The passive (inactive) coil will be held flat over the skull surface with the coil handle held at approximately 45 degrees to the floor.
An active coil will be held vertically in a mechanical holder 50 cm behind the subject head and run at 10 Hz with an intensity set to 150% of motor threshold.
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
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The primary outcome measure will be global mean field amplitude (GMFA) before and after treatment with true or sham rTMS using a range of stimulus train durations and several stimulation sites.
Délai: The GMFA will be measured for 1 minutes after each rTMS train is delivered.
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The GMFA will be measured for 1 minutes after each rTMS train is delivered.
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Secondary outcome measures will include magnetically evoked response potentials in the multi-channel recorded EEG signals.
Délai: The L/R APR will be measured for 1 minute after each TMS train is delivered.
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The magnetically evoked response potentials will be measured over the first 500 milliseconds after each TMS pulse. We will also determine weather rTMS can produce measurable changes in left/right alpha power ratio (L/R APR). The L/R APR will be measured for 1 minute after each TMS train is delivered. |
The L/R APR will be measured for 1 minute after each TMS train is delivered.
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Gary Hasey, MD, St. Joseph's Health Care London
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 juillet 2007
Achèvement primaire (Réel)
1 août 2010
Achèvement de l'étude (Réel)
1 août 2010
Dates d'inscription aux études
Première soumission
18 septembre 2010
Première soumission répondant aux critères de contrôle qualité
7 juin 2011
Première publication (Estimation)
8 juin 2011
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
8 juin 2011
Dernière mise à jour soumise répondant aux critères de contrôle qualité
7 juin 2011
Dernière vérification
1 juillet 2007
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- 07-2827
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .