Examining the Effects of Reduced Environmental Stimulation on the Brain

September 18, 2020 updated by: 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74136
        • Laureate Institute for Brain Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Floating
The participant will float supine in water with a high concentration of Epsom salt for 90 minutes.
Behavioral: Floating
Floating in either a pool saturated with Epsom salt or in a zero-gravity chair
Placebo Comparator: Chair
The participant will lay in the supine position while reclined in a zero-gravity chair for 90 minutes.
Behavioral: Floating
Floating in either a pool saturated with Epsom salt or in a zero-gravity chair

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Brain activation changes in limbic and paralimbic neural circuitry from pre- to post-float as measured with functional magnetic resonance imaging (fMRI)
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Laureate Institute for Brain Research, Inc.

Investigators

  • Principal Investigator: Justin Feinstein, PhD, Laureate Institute for Brain Research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2015

Primary Completion (Actual)

December 1, 2019

Study Completion (Actual)

December 31, 2019

Study Registration Dates

First Submitted

May 18, 2015

First Submitted That Met QC Criteria

May 21, 2015

First Posted (Estimate)

May 22, 2015

Study Record Updates

Last Update Posted (Actual)

September 22, 2020

Last Update Submitted That Met QC Criteria

September 18, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • float-fMRI-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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