Ignite Creation Date:
2024-05-06 @ 3:32 PM
Last Modification Date:
2024-10-26 @ 1:51 PM
Study NCT ID:
NCT04664790
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-03
First Post:
2020-11-24
Brief Title:
Hyperbaric Oxygen Therapy Compared to Cognitive Training in FASD
Sponsor:
Assaf-Harofeh Medical Center
Organization:
Assaf-Harofeh Medical Center
Study Overview
Official Title:
Hyperbaric Oxygen Therapy vs Cognitive Training for Fetal Alcohol Spectrum Disorder A Prospective Randomized Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Fetal Alcohol Spectrum Disorder FASD describes a wide range of adverse physical behavioral and cognitive effects resulting from prenatal alcohol exposure PAE during embryonic and fetal development A number of clinical studies have presented evidence regarding the physiological effects of HBOT on metabolically dysfunctional brain regions that might be related to FASD The aim of the study is to compare the effect of HBOT vs neurocognitive training on neurobehavioral function in FASD
Detailed Description:
Fetal Alcohol Spectrum Disorder FASD describes a wide range of adverse physical behavioral and cognitive effects resulting from prenatal alcohol exposure PAE during embryonic and fetal development Currently individuals afflicted by FASD are treated symptomatically for ADHD and different forms of disruptive behavior However these approaches have not succeeded in improving the long-term clinical outcome 1
A number of clinical studies have presented evidence regarding the physiological effects of hyperbaric oxygen therapy HBOT on metabolically dysfunctional brain regions that might be related to FASD 2-5 Case studies conducted using HBOT suggested a potential safe and efficient treatment for FESD 6-7 The aim of the study is to compare the effect of HBOT vs neurocognitive training on neurobehavioral function in FASD
The study is designed as a prospective randomized two active arm trial After enrolment eligible participants will be randomized with equal probability into one of two arms HBOT or cognitive training arm The evaluation procedure will be performed twice at baseline and 1-3 weeks after the last treatment session and includes cognitive tests FASD relegated questionnaires and anatomical and functional brain imaging MRI and SPECT The study is designed as an intention to treat trial and thus patients will be included in the analysis if they completed at least one HBOTcognitive training session and attained post treatment study analysis
The HBOT protocol will be administrated in a multi-place chamber The protocol comprised of 60 daily sessions 5 sessions per week within a three month period Each session includes breathing 100 oxygen by mask at 2ATA for 90 minutes with 5-minute air breaks every 20 minutes
The cognitive training protocol contains a neuropsychologist guided BrainHQ training program This is a 3 months program that includes 30 minutes sessions at least 3 times per week
A number of clinical studies have presented evidence regarding the physiological effects of hyperbaric oxygen therapy HBOT on metabolically dysfunctional brain regions that might be related to FASD 2-5 Case studies conducted using HBOT suggested a potential safe and efficient treatment for FESD 6-7 The aim of the study is to compare the effect of HBOT vs neurocognitive training on neurobehavioral function in FASD
The study is designed as a prospective randomized two active arm trial After enrolment eligible participants will be randomized with equal probability into one of two arms HBOT or cognitive training arm The evaluation procedure will be performed twice at baseline and 1-3 weeks after the last treatment session and includes cognitive tests FASD relegated questionnaires and anatomical and functional brain imaging MRI and SPECT The study is designed as an intention to treat trial and thus patients will be included in the analysis if they completed at least one HBOTcognitive training session and attained post treatment study analysis
The HBOT protocol will be administrated in a multi-place chamber The protocol comprised of 60 daily sessions 5 sessions per week within a three month period Each session includes breathing 100 oxygen by mask at 2ATA for 90 minutes with 5-minute air breaks every 20 minutes
The cognitive training protocol contains a neuropsychologist guided BrainHQ training program This is a 3 months program that includes 30 minutes sessions at least 3 times per week
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None