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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

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

    • Ontario
      • Hamilton, Ontario, Canadá, L8N 3K7
        • St. Joseph's Healthcare, Centre for Mountain Health Services

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

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
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:
  • Magstim super rapid left true 10 Hz
Comparador de placebos: 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.
Otros nombres:
  • Magstim super rapid left passive sham 10 Hz

¿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.
The GMFA will be measured for 1 minutes after each rTMS train is delivered.

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.

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.

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

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

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. .

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