Examining the Effects of Reduced Environmental Stimulation on the Brain
NCT ID: NCT02452203
Last Updated: 2020-09-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
56 participants
INTERVENTIONAL
2015-05-01
2019-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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Floating
The participant will float supine in water with a high concentration of Epsom salt for 90 minutes.
Floating
Floating in either a pool saturated with Epsom salt or in a zero-gravity chair
Chair
The participant will lay in the supine position while reclined in a zero-gravity chair for 90 minutes.
Floating
Floating in either a pool saturated with Epsom salt or in a zero-gravity chair
Interventions
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Floating
Floating in either a pool saturated with Epsom salt or in a zero-gravity chair
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
55 Years
ALL
Yes
Sponsors
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Laureate Institute for Brain Research, Inc.
OTHER
Responsible Party
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Justin Feinstein
Principal Investigator
Principal Investigators
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Justin Feinstein, PhD
Role: PRINCIPAL_INVESTIGATOR
Laureate Institute for Brain Research
Locations
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Laureate Institute for Brain Research
Tulsa, Oklahoma, United States
Countries
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References
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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.
Other Identifiers
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float-fMRI-1
Identifier Type: -
Identifier Source: org_study_id
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