- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00063245
Stimulating Deep Brain Regions With a Magnetic Stimulator
Noninvasive Stimulation of Human Deep Brain Regions With a Magnetic Stimulator
The purpose of this study is to determine whether a special coil designed for magnetic stimulation of areas deep in the brain can affect mood and emotion in healthy volunteers. Researchers hope to better understand how the brain controls mood and motivation and what goes wrong with this process in disease.
For transcranial magnetic stimulation (TMS), a wire coil is held over the scalp. A brief electrical current passes through the coil and creates a magnetic pulse that stimulates the brain.
Eighteen participants, 9 men and 9 women, will be enrolled in this study. They will be assigned to one or both of the following two experiments.
Experiment 1
In this experiment, researchers will test the effectiveness of a new type of wire coil. They will deliver magnetic impulses of varying strength. Approximately 150 stimulations will be given over of about 20 minutes. To determine whether the coil causes any problem with hearing, participants will undergo a hearing test immediately before and after the experiment.
Experiment 2
This experiment, which has two parts, is designed to determine whether TMS can affect mood. In the first part, participants will be asked to report any changes in mood before, during and after the magnetic stimulation. In the second part, they will be asked to choose between sets of 2 identical pictures-choosing one will result in full magnetic stimulation, choosing the other will result in stimulation at 10 percent of full intensity.
Participants will be compensated up to $100 for their involvement in this study.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
Tipo de estudio
Inscripción
Contactos y Ubicaciones
Ubicaciones de estudio
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Maryland
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Bethesda, Maryland, Estados Unidos, 20892
- National Institute of Neurological Disorders and Stroke (NINDS)
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
INCLUSION CRITERIA:
The study is planned for adult subjects with normal neurologic and psychiatric examinations.
Healthy male and female volunteers will be included in this protocol.
EXCLUSION CRITERIA:
History of surgery with metallic implants or known history of metallic particles in the eye, cardiac pacemaker, neurostimulators, cochlear implants, history of drug abuse, psychiatric illness, hypertension, or concurrent medication.
Children are also excluded.
Plan de estudios
¿Cómo está diseñado el estudio?
Colaboradores e Investigadores
Publicaciones y enlaces útiles
Publicaciones Generales
- Breiter HC, Gollub RL, Weisskoff RM, Kennedy DN, Makris N, Berke JD, Goodman JM, Kantor HL, Gastfriend DR, Riorden JP, Mathew RT, Rosen BR, Hyman SE. Acute effects of cocaine on human brain activity and emotion. Neuron. 1997 Sep;19(3):591-611. doi: 10.1016/s0896-6273(00)80374-8.
- Breiter HC, Rosen BR. Functional magnetic resonance imaging of brain reward circuitry in the human. Ann N Y Acad Sci. 1999 Jun 29;877:523-47. doi: 10.1111/j.1749-6632.1999.tb09287.x.
- Eaton H. Electric field induced in a spherical volume conductor from arbitrary coils: application to magnetic stimulation and MEG. Med Biol Eng Comput. 1992 Jul;30(4):433-40. doi: 10.1007/BF02446182.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización del estudio
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- 030231
- 03-N-0231
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