Examining the Effects of Reduced Environmental Stimulation on the Brain
1 other identifier
interventional
56
1 country
1
Brief Summary
The studies proposed in this protocol aim to explore the anxiolytic properties of floating as it relates to the central and autonomic nervous system.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable anxiety
Started May 2015
Longer than P75 for not_applicable anxiety
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2015
CompletedFirst Submitted
Initial submission to the registry
May 18, 2015
CompletedFirst Posted
Study publicly available on registry
May 22, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2019
CompletedSeptember 22, 2020
September 1, 2020
4.6 years
May 18, 2015
September 18, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Brain activation changes in limbic and paralimbic neural circuitry from pre- to post-float as measured with functional magnetic resonance imaging (fMRI)
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
Study Arms (2)
Floating
EXPERIMENTALThe participant will float supine in water with a high concentration of Epsom salt for 90 minutes.
Chair
PLACEBO COMPARATORThe participant will lay in the supine position while reclined in a zero-gravity chair for 90 minutes.
Interventions
Floating in either a pool saturated with Epsom salt or in a zero-gravity chair
Eligibility Criteria
You may qualify if:
- 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.
- 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.
You may not qualify if:
- Participant meets criteria for a DSM5 Axis-1 disorder.
- Participant endorses current suicidal ideation with intent or plan.
- Participant fails to adhere to our "Pre-float checklist".
- Participant is morbidly obese (BMI \> 40).
- 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).
- 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.
- Pregnancy as detected by a urine test.
- Non-correctable vision or hearing problems.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Laureate Institute for Brain Research
Tulsa, Oklahoma, 74136, United States
Related Publications (1)
Al Zoubi O, Misaki M, Bodurka J, Kuplicki R, Wohlrab C, Schoenhals WA, Refai HH, Khalsa SS, Stein MB, Paulus MP, Feinstein JS. Taking the body off the mind: Decreased functional connectivity between somatomotor and default-mode networks following Floatation-REST. Hum Brain Mapp. 2021 Jul;42(10):3216-3227. doi: 10.1002/hbm.25429. Epub 2021 Apr 9.
PMID: 33835628DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Justin Feinstein, PhD
Laureate Institute for Brain Research
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
May 18, 2015
First Posted
May 22, 2015
Study Start
May 1, 2015
Primary Completion
December 1, 2019
Study Completion
December 31, 2019
Last Updated
September 22, 2020
Record last verified: 2020-09
Data Sharing
- IPD Sharing
- Will not share