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Project Title:  Ophthalmic and Intracranial Structural Changes in Head-Down Tilt Bedrest: Potential Countermeasures and Comparison to SANS Findings in Astronauts (OPTICS study) Reduce
Images: icon  Fiscal Year: FY 2021 
Division: Human Research 
Research Discipline/Element:
HRP HHC:Human Health Countermeasures
Start Date: 04/08/2020  
End Date: 10/12/2020  
Task Last Updated: 12/10/2021 
Download report in PDF pdf
Principal Investigator/Affiliation:   Martin, Bryn  Ph.D. / Alcyone Therapeutics, Inc. 
Address:  116 John St #300 
 
Lowell , MA 01852-1124 
Email: Bryn@alcyonetx.com 
Phone: 330-475-9747  
Congressional District:
Web:  
Organization Type: INDUSTRY 
Organization Name: Alcyone Therapeutics, Inc. 
Joint Agency:  
Comments: PI moved to Alcyone Therapeutics, Inc., in late 2020 from University of Idaho (Ed., December 2021) 
Co-Investigator(s)
Affiliation: 
Fu, Qiuyan  Ph.D. University of Idaho, Moscow 
Kramer, Larry  M.D. University of Texas Health Science Center at Houston 
Laurie, Steven  Ph.D. KBR/NASA Johnson Space Center 
Macias, Brandon  Ph.D. NASA Johnson Space Center 
Marshall-Goebel, Karina  Ph.D. KBR/NASA Johnson Space Center 
Williams, Michael  M.D. University of Washington, Seattle 
Loerch, Linda  Ph.D. NASA Johnson Space Center 
Project Information: Grant/Contract No. 80NSSC20K0920 
Responsible Center: NASA JSC 
Grant Monitor: Stenger, Michael  
Center Contact: 281-483-1311 
michael.b.stenger@nasa.gov 
Solicitation / Funding Source: 2018-2019 HERO 80JSC018N0001-SANS: Spaceflight Associated Neuro-ocular Syndrome Countermeasures. Appendix C 
Grant/Contract No.: 80NSSC20K0920 
Project Type: GROUND 
Flight Program:  
TechPort: No 
No. of Post Docs:  
No. of PhD Candidates:  
No. of Master's Candidates:  
No. of Bachelor's Candidates:  
No. of PhD Degrees:  
No. of Master's Degrees:  
No. of Bachelor's Degrees:  
Human Research Program Elements: (1) HHC:Human Health Countermeasures
Human Research Program Risks: (1) SANS:Risk of Spaceflight Associated Neuro-ocular Syndrome (IRP Rev I)
Human Research Program Gaps: (1) SANS-302:Test mechanical countermeasures in a strict bed rest analog (IRP Rev L)
(2) SANS-401:Test non-mechanical countermeasures in a strict bed rest analog (IRP Rev L)
Flight Assignment/Project Notes: NOTE: End date changed to 10/12/2020 per JSC Grants Admin/NSSC information, due to PI move and new grant established (Ed., 12/10/21)

Task Description: Spaceflight associated neuro-ocular syndrome (SANS) is a combination of pathological ophthalmic findings that have been documented in a subset of astronauts that participated in long duration missions (6+ months) to the International Space Station. The leading hypothesis for SANS is that the lack of a gravitational vector acting on the body results in a headward body fluid shift that can lead to damage to the eye. Recent findings from our research team show that multiple structural changes in the eye and brain occur in astronauts with SANS. To help mitigate these structural changes, we need to validate a ground-based analog for spaceflight. Strict head-down tilt bedrest has been investigated extensively as a spaceflight analog. However, we do not know if the chronic headward fluid shift that occurs during bedrest results in similar ocular and brain structural changes observed during spaceflight.

The objective of our proposal is to use non-invasive magnetic resonance imaging to quantify structural and physiologic changes in the brain and eye that occur in prolonged 6 degree head down tilt bedrest (HDT) and understand if these alterations can be mitigated using countermeasures. Our central hypothesis is that ophthalmic and intracranial alterations will be similar in prolonged bed rest compared to long-duration astronauts with SANS, and these alterations will be reduced by countermeasures applied during HDT. We will test this hypothesis by a) quantification of ophthalmic and intracranial alterations in HDT subjects and ambulatory control subjects compared to pre-HDT (Aim 1), b) determination if countermeasures can prevent and/or reduce HDT-induced alterations (Aim 2), and c) comparison of alterations in HDT subjects to those already quantified in astronauts that developed SANS (Aim 3).

Our approach to accomplish these aims will include a total of 48 participants that are randomly assigned to four groups, each with 12 people in total. All participants will be imaged by magnetic resonance imaging and optical coherence tomography at a baseline time point, 30 days after the study start, and 1 to 3 days following study completion. During the 30-day period, Group 1 will be seated in the daytime and supine at night, and Group 2 will adhere to a strict 6 degree HDT. Group 3 and 4 will both adhere to a strict 6 degree HDT, but they will also undergo a mechanical and other countermeasure (to be determined). Using the imaging data collected in each group, we will quantify changes in the eye and brain at each time point. These alterations will be statistically compared across Group 1 through 4 to accomplish Aim 1 and 2. To accomplish Aim 3, we will compare alterations in Group 1 and 2 to alterations that we previously quantified in astronauts with SANS (Group 5).

Upon completion of the research, we will begin to validate what degree of HDT is suitable as a spaceflight analog. Ultimately, this research will provide valuable information to support countermeasure optimization and implementation. The research uniquely addresses the related Program Requirements Document (PRD) risk SANS GAPs 1 (SANS1: We do not know the etiological mechanisms and contributing risk factors for ocular structural and functional changes seen in-flight and postflight), 12 (SANS12: We do not know whether ground-based analogs and/or models can simulate Space Associated Neuro-ocular Syndrome), and 13 (SANS13: We need to identify preventative and treatment countermeasures (CMs) to mitigate changes in ocular structure and function and intracranial pressure during spaceflight.). A unique value of our research plan is that we will use identical methods to compare structural changes in the eye and brain in bed rest subjects to changes in these structures that our group has already obtained in astronauts with SANS. In addition, the study team includes multiple personnel with extensive experience working with NASA investigators, bed-rest studies, countermeasure development and testing, and all aspects of the imaging methods to be applied.

NOTE: End date changed to 10/12/2020 per JSC Grants Admin/NSSC information, due to PI move and new grant established (Ed., 12/10/21)

Research Impact/Earth Benefits:

Task Progress & Bibliography Information FY2021 
Task Progress: NOTE: End date changed to 10/12/2020 per JSC Grants Admin/NSSC information, due to PI move and new grant established. See continuation grant, "Ophthalmic and Intracranial Structural Changes in Head-Down Tilt Bedrest: Potential Countermeasures and Comparison to SANS Findings in Astronauts (OPTICS study)--80NSSC22K0023", for subsequent reporting (Ed., 12/10/21)

Bibliography Type: Description: (Last Updated: )  Show Cumulative Bibliography Listing
 
 None in FY 2021
Project Title:  Ophthalmic and Intracranial Structural Changes in Head-Down Tilt Bedrest: Potential Countermeasures and Comparison to SANS Findings in Astronauts (OPTICS study) Reduce
Images: icon  Fiscal Year: FY 2020 
Division: Human Research 
Research Discipline/Element:
HRP HHC:Human Health Countermeasures
Start Date: 04/08/2020  
End Date: 10/12/2020  
Task Last Updated: 06/14/2020 
Download report in PDF pdf
Principal Investigator/Affiliation:   Martin, Bryn  Ph.D. / Alcyone Therapeutics, Inc. 
Address:  116 John St #300 
 
Lowell , MA 01852-1124 
Email: Bryn@alcyonetx.com 
Phone: 330-475-9747  
Congressional District:
Web:  
Organization Type: INDUSTRY 
Organization Name: Alcyone Therapeutics, Inc. 
Joint Agency:  
Comments: PI moved to Alcyone Therapeutics, Inc., in late 2020 from University of Idaho (Ed., December 2021) 
Co-Investigator(s)
Affiliation: 
Fu, Qiuyan  Ph.D. University of Idaho, Moscow 
Kramer, Larry  M.D. University of Texas Health Science Center at Houston 
Laurie, Steven  Ph.D. KBR/NASA Johnson Space Center 
Macias, Brandon  Ph.D. NASA Johnson Space Center 
Marshall-Goebel, Karina  Ph.D. KBR/NASA Johnson Space Center 
Williams, Michael  M.D. University of Washington, Seattle 
Loerch, Linda  Ph.D. NASA Johnson Space Center 
Project Information: Grant/Contract No. 80NSSC20K0920 
Responsible Center: NASA JSC 
Grant Monitor: Norsk, Peter  
Center Contact:  
Peter.norsk@nasa.gov 
Solicitation / Funding Source: 2018-2019 HERO 80JSC018N0001-SANS: Spaceflight Associated Neuro-ocular Syndrome Countermeasures. Appendix C 
Grant/Contract No.: 80NSSC20K0920 
Project Type: GROUND 
Flight Program:  
TechPort: No 
No. of Post Docs:  
No. of PhD Candidates:  
No. of Master's Candidates:  
No. of Bachelor's Candidates:  
No. of PhD Degrees:  
No. of Master's Degrees:  
No. of Bachelor's Degrees:  
Human Research Program Elements: (1) HHC:Human Health Countermeasures
Human Research Program Risks: (1) SANS:Risk of Spaceflight Associated Neuro-ocular Syndrome (IRP Rev I)
Human Research Program Gaps: (1) SANS-302:Test mechanical countermeasures in a strict bed rest analog (IRP Rev L)
(2) SANS-401:Test non-mechanical countermeasures in a strict bed rest analog (IRP Rev L)
Flight Assignment/Project Notes: NOTE: End date changed to 10/12/2020 per JSC Grants Admin/NSSC information, due to PI move and new grant established (Ed., 12/10/21)

Task Description: Spaceflight associated neuro-ocular syndrome (SANS) is a combination of pathological ophthalmic findings that have been documented in a subset of astronauts that participated in long duration missions (6+ months) to the International Space Station. The leading hypothesis for SANS is that the lack of a gravitational vector acting on the body results in a headward body fluid shift that can lead to damage to the eye. Recent findings from our research team show that multiple structural changes in the eye and brain occur in astronauts with SANS. To help mitigate these structural changes, we need to validate a ground-based analog for spaceflight. Strict head-down tilt bedrest has been investigated extensively as a spaceflight analog. However, we do not know if the chronic headward fluid shift that occurs during bedrest results in similar ocular and brain structural changes observed during spaceflight.

The objective of our proposal is to use non-invasive magnetic resonance imaging to quantify structural and physiologic changes in the brain and eye that occur in prolonged 6 degree head down tilt bedrest (HDT) and understand if these alterations can be mitigated using countermeasures. Our central hypothesis is that ophthalmic and intracranial alterations will be similar in prolonged bed rest compared to long-duration astronauts with SANS, and these alterations will be reduced by countermeasures applied during HDT. We will test this hypothesis by a) quantification of ophthalmic and intracranial alterations in HDT subjects and ambulatory control subjects compared to pre-HDT (Aim 1), b) determination if countermeasures can prevent and/or reduce HDT-induced alterations (Aim 2), and c) comparison of alterations in HDT subjects to those already quantified in astronauts that developed SANS (Aim 3).

Our approach to accomplish these aims will include a total of 48 participants that are randomly assigned to four groups, each with 12 people in total. All participants will be imaged by magnetic resonance imaging and optical coherence tomography at a baseline time point, 30 days after the study start, and 1 to 3 days following study completion. During the 30-day period, Group 1 will be seated in the daytime and supine at night, and Group 2 will adhere to a strict 6 degree HDT. Group 3 and 4 will both adhere to a strict 6 degree HDT, but they will also undergo a mechanical and other countermeasure (to be determined). Using the imaging data collected in each group, we will quantify changes in the eye and brain at each time point. These alterations will be statistically compared across Group 1 through 4 to accomplish Aim 1 and 2. To accomplish Aim 3, we will compare alterations in Group 1 and 2 to alterations that we previously quantified in astronauts with SANS (Group 5).

Upon completion of the research, we will begin to validate what degree of HDT is suitable as a spaceflight analog. Ultimately, this research will provide valuable information to support countermeasure optimization and implementation. The research uniquely addresses the related Program Requirements Document (PRD) risk SANS GAPs 1 (SANS1: We do not know the etiological mechanisms and contributing risk factors for ocular structural and functional changes seen in-flight and postflight), 12 (SANS12: We do not know whether ground-based analogs and/or models can simulate Space Associated Neuro-ocular Syndrome), and 13 (SANS13: We need to identify preventative and treatment countermeasures (CMs) to mitigate changes in ocular structure and function and intracranial pressure during spaceflight.). A unique value of our research plan is that we will use identical methods to compare structural changes in the eye and brain in bed rest subjects to changes in these structures that our group has already obtained in astronauts with SANS. In addition, the study team includes multiple personnel with extensive experience working with NASA investigators, bed-rest studies, countermeasure development and testing, and all aspects of the imaging methods to be applied.

Research Impact/Earth Benefits:

Task Progress & Bibliography Information FY2020 
Task Progress: New project for FY2020.

Bibliography Type: Description: (Last Updated: )  Show Cumulative Bibliography Listing
 
 None in FY 2020