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- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01369264
The Effect of Repetitive Transcranial Magnetic Stimulation on Brain Activity in Healthy Human Volunteers (ERP)
7 de junio de 2011 actualizado por: 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).
Descripción general del estudio
Estado
Terminado
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Actual)
17
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Ontario
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Hamilton, Ontario, Canadá, L8N 3K7
- St. Joseph's Healthcare, Centre for Mountain Health Services
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años a 65 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
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 de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Ciencia básica
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: 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
Otros nombres:
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Comparador de placebos: Passive sham left high frequency
Passive sham 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 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.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
---|---|
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.
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Secondary outcome measures will include magnetically evoked response potentials in the multi-channel recorded EEG signals.
Periodo de tiempo: 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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Gary Hasey, MD, St. Joseph's Health Care London
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de julio de 2007
Finalización primaria (Actual)
1 de agosto de 2010
Finalización del estudio (Actual)
1 de agosto de 2010
Fechas de registro del estudio
Enviado por primera vez
18 de septiembre de 2010
Primero enviado que cumplió con los criterios de control de calidad
7 de junio de 2011
Publicado por primera vez (Estimar)
8 de junio de 2011
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
8 de junio de 2011
Última actualización enviada que cumplió con los criterios de control de calidad
7 de junio de 2011
Última verificación
1 de julio de 2007
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- 07-2827
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .