Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

Examining the Effects of Reduced Environmental Stimulation on the Brain

18 de septiembre de 2020 actualizado por: Justin Feinstein, Laureate Institute for Brain Research, Inc.
The studies proposed in this protocol aim to explore the anxiolytic properties of floating as it relates to the central and autonomic nervous system.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

The human brain is constantly bombarded with sensory information from the external world. This series of studies aim to explore the effects of reducing environmental stimulation using specially designed floatation pools that minimize visual, auditory, tactile, proprioceptive, and thermal input to the brain. Previous research has shown that "floating" in this unique setting can significantly reduce levels of anxiety, stress, blood pressure, and cortisol, while significantly increasing levels of both subjective and physiological forms of relaxation. Much of this past research contained various methodological weaknesses, including small sample sizes, lack of a control group, and no longitudinal follow-up. Moreover, very little is known about the potential benefits of floating in clinical populations, and essentially nothing is known about the effects of floating on the brain. The studies proposed in this protocol aim to further explore floating's potentially salubrious effect on the autonomic nervous system, while beginning to investigate its largely unknown effect on the central nervous system. The researchers have attempted to improve upon the weaknesses of past research by using larger sample sizes, a control group, and a longitudinal design. The current project is focused on documenting the subjective, behavioral, physiological and neural effects of floating in healthy and anxious populations. The subjective effects of floating will be examined using self-report measures and the experience sampling method. The behavioral effects of floating will be examined using measures of interoceptive awareness and distress tolerance. The physiological effects of floating will be examined using waterproof and wireless tracking of blood pressure, heart rate, respiration, and movement, in addition to collecting measures of cortisol and magnesium. A portable electroencephalography (EEG) system will be used to measure sleep during the nights before and after a float experience. The neural effects of floating will be examined using waterproof and wireless EEG collected during the float experience, as well as using functional magnetic resonance imaging (fMRI) collected before and immediately after floating. Using a longitudinal within-subject design, the researchers have a unique opportunity to assess not only functional brain changes, but also structural brain changes induced by repeated exposures to floating. An active control condition aims to control for the effects of simple relaxation by collecting all of the same measures while participants lay supine in a zero-gravity chair situated in a quiet, dimly lit room. This program of research constitutes the first systematic investigation of floating on the body and the brain, and the findings have the potential to illuminate the physiological and neural correlates of the deep relaxation induced by the floating experience.

Tipo de estudio

Intervencionista

Inscripción (Actual)

56

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

    • Oklahoma
      • Tulsa, Oklahoma, Estados Unidos, 74136
        • Laureate Institute for Brain Research

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 55 años (Adulto)

Acepta Voluntarios Saludables

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  1. Participants must be between 18-55 years of age, free of any current or past neurological or psychiatric illness, and capable of performing all tasks during each session of the experiment.
  2. They must be able to provide written informed consent and must have sufficient proficiency in the English language to understand and complete interviews, questionnaires, and all other study procedures.

Exclusion Criteria:

  1. Participant meets criteria for a DSM5 Axis-1 disorder.
  2. Participant endorses current suicidal ideation with intent or plan.
  3. Participant fails to adhere to our "Pre-float checklist".
  4. Participant is morbidly obese (BMI > 40).
  5. Certain drugs or medications consumed within the past week including any psychoactive drugs (e.g., benzodiazepines, opiates, selective serotonin reuptake inhibitors, dopamine agonists, barbiturates, MDMA, LSD, psilocybin, peyote, phencyclidine, ketamine). For all other medications, we require the participant to be stably medicated prior to participation (defined as having taken the medication for 6 weeks or longer).
  6. Participant has a history of unstable liver or renal insufficiency; glaucoma; diabetes; significant and unstable cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, or metabolic disturbance; or any other condition that, in the opinion of the investigator, would make participation not be in the best interest (e.g., compromise the well-being) of the subject or that could prevent, limit, or confound the protocol-specified assessments.
  7. Pregnancy as detected by a urine test.
  8. Non-correctable vision or hearing problems.
  9. MRI contraindications including: cardiac pacemaker, metal fragments in eyes/skin/body (shrapnel), aortic/aneurysm clips, prosthesis, by-pass surgery/coronary artery clips, hearing aid, heart valve replacement, shunt (ventricular or spinal), electrodes, metal plates/pins/screws/ wires, or neuro/bio-stimulators (TENS unit), persons who have ever been a professional metal worker/welder, history of eye surgery/eyes washed out because of metal, vision problems uncorrectable with lenses, inability to lie still on one's back for 60-120 minutes; prior neurosurgery; tattoos or cosmetic makeup with metal dyes, unwillingness to remove body piercings, and pregnancy.

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 paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Floating
The participant will float supine in water with a high concentration of Epsom salt for 90 minutes.
Floating in either a pool saturated with Epsom salt or in a zero-gravity chair
Comparador de placebos: Chair
The participant will lay in the supine position while reclined in a zero-gravity chair for 90 minutes.
Floating in either a pool saturated with Epsom salt or in a zero-gravity chair

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Brain activation changes in limbic and paralimbic neural circuitry from pre- to post-float as measured with functional magnetic resonance imaging (fMRI)
Periodo de tiempo: fMRI will be undertaken before floating and then immediately following the 3rd float session, an average time frame of 3 weeks
MRI scan to measure the blood flow changes in the brain
fMRI will be undertaken before floating and then immediately following the 3rd float session, an average time frame of 3 weeks

Colaboradores e Investigadores

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

Investigadores

  • Investigador principal: Justin Feinstein, PhD, Laureate Institute for Brain Research

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

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 (Actual)

1 de mayo de 2015

Finalización primaria (Actual)

1 de diciembre de 2019

Finalización del estudio (Actual)

31 de diciembre de 2019

Fechas de registro del estudio

Enviado por primera vez

18 de mayo de 2015

Primero enviado que cumplió con los criterios de control de calidad

21 de mayo de 2015

Publicado por primera vez (Estimar)

22 de mayo de 2015

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

22 de septiembre de 2020

Última actualización enviada que cumplió con los criterios de control de calidad

18 de septiembre de 2020

Última verificación

1 de septiembre de 2020

Más información

Términos relacionados con este estudio

Palabras clave

Otros números de identificación del estudio

  • float-fMRI-1

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

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. .

Suscribir