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Trial record 2 of 8 for:    "Orthostatic Intolerance" | "Bromides"

Acetylcholinesterase Inhibition and Orthostatic Hypotension in SCI

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ClinicalTrials.gov Identifier: NCT02307526
Recruitment Status : Completed
First Posted : December 4, 2014
Results First Posted : July 21, 2017
Last Update Posted : July 21, 2017
Sponsor:
Information provided by (Responsible Party):
Jill M. Wecht, Ed.D., James J. Peters Veterans Affairs Medical Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hypotension, Postural
Interventions Drug: Pyridostigmine Bromide
Device: Tilt table test
Enrollment 10
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Spinal Cord Injury
Hide Arm/Group Description 10 individuals with spinal cord injury (SCI: C4-C7) were recruited.
Period Title: Day 1 - No Drug
Started 10
Completed 10
Not Completed 0
Period Title: Day 2 - 60 mg of Pyridostigmine
Started 10
Completed 10
Not Completed 0
Arm/Group Title Spinal Cord Injury
Hide Arm/Group Description Ten individuals with SCI (C4-C7) were recruited.
Overall Number of Baseline Participants 10
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
<=18 years
0
   0.0%
Between 18 and 65 years
10
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants
38  (10)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
Female
1
  10.0%
Male
9
  90.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10 participants
10
1.Primary Outcome
Title Systolic Blood Pressure
Hide Description [Not Specified]
Time Frame Average systolic blood pressure of 10 minutes supine rest before pyridostigmine and after 45 minutes at 45 degrees after pyridostigmine administration compared to 10 minutes supine rest before tilt and at 45 degrees during no-drug head-up tilt maneuver.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pyridostigmine Bromide NO Drug
Hide Arm/Group Description:
After being transferred onto a tilt table, subject will lie in a rested, supine position in which the study drug, pyridostigmine bromide will be administered at the 30 minute time point. Following the administration of the study drug, the subject will remain in the supine position for an additional 30 minutes until the tilting protocol commences.
Following the 60 minute resting position, a progressive head-up tilt will be utilized in which the table will be adjusted to 15°, 25°, 35° for 5 minutes at each angle and then maintained at 45° for 45 minutes or until the subjects experiences symptoms of compromised cerebral blood flow, which include, but are not limited to, light headedness, blurry vision, dizziness and nausea.
Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: mm Hg
Supine Systolic Blood Pressure 97  (11) 103  (14)
45 degree Head-up Tilt Systolic Blood Pressure 90  (18) 88  (12)
2.Primary Outcome
Title Diastolic Blood Pressure
Hide Description [Not Specified]
Time Frame Average diastolic blood pressure of 10 minutes supine rest before pyridostigmine and after 45 minutes at 45 degrees after pyridostigmine administration compared to 10 minutes supine rest before tilt and at 45 degrees during no-drug head-up tilt maneuver.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pyridostigmine Bromide NO Drug
Hide Arm/Group Description:
After being transferred onto a tilt table, subject will lie in a rested, supine position in which the study drug, pyridostigmine bromide will be administered at the 30 minute time point. Following the administration of the study drug, the subject will remain in the supine position for an additional 30 minutes until the tilting protocol commences.
Following the 60 minute resting position, a progressive head-up tilt will be utilized in which the table will be adjusted to 15°, 25°, 35° for 5 minutes at each angle and then maintained at 45° for 45 minutes or until the subjects experiences symptoms of compromised cerebral blood flow, which include, but are not limited to, light headedness, blurry vision, dizziness and nausea.
Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: mm Hg
Supine Diastolic Blood Pressure 64  (6) 66  (10)
45 degree Head-up Tilt Diastolic Blood Pressure 64  (11) 63  (7)
3.Primary Outcome
Title Heart Rate
Hide Description [Not Specified]
Time Frame Average heart rate of 10 minutes supine rest before pyridostigmine and after 45 minutes at 45 degrees following pyridostigmine administration compared to 10 minutes supine rest before tilt and at 45 degrees during no-drug head-up tilt maneuver.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pyridostigmine Bromide NO Drug
Hide Arm/Group Description:
After being transferred onto a tilt table, subject will lie in a rested, supine position in which the study drug, pyridostigmine bromide will be administered at the 30 minute time point. Following the administration of the study drug, the subject will remain in the supine position for an additional 30 minutes until the tilting protocol commences.
Following the 60 minute resting position, a progressive head-up tilt will be utilized in which the table will be adjusted to 15°, 25°, 35° for 5 minutes at each angle and then maintained at 45° for 45 minutes or until the subjects experiences symptoms of compromised cerebral blood flow, which include, but are not limited to, light headedness, blurry vision, dizziness and nausea.
Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: bpm
Supine Heart Rate 52  (6) 55  (10)
45 degree Head-up Tilt Heart Rate 66  (12) 72  (13)
Time Frame 80 minuets after pyridostigmine administration to 200 minuets after pyridostigmine administration.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Day 1 - No Drug Day 2 - Pyridostigmine Bromide
Hide Arm/Group Description Following the 60 minute resting position, a progressive head-up tilt will be utilized in which the table will be adjusted to 15°, 25°, 35° for 5 minutes at each angle and then maintained at 45° for 45 minutes or until the subjects experiences symptoms of compromised cerebral blood flow, which include, but are not limited to, light headedness, blurry vision, dizziness and nausea. After being transferred onto a tilt table, subject will lie in a rested, supine position in which the study drug, pyridostigmine bromide 60 mg will be administered at the 30 minute time point. Following the administration of the study drug, the subject will remain in the supine position for an additional 30 minutes until the tilting protocol commences.
All-Cause Mortality
Day 1 - No Drug Day 2 - Pyridostigmine Bromide
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Day 1 - No Drug Day 2 - Pyridostigmine Bromide
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/10 (0.00%)      2/10 (20.00%)    
Nervous system disorders     
Drug Side Effect  [1]  0/10 (0.00%)  0 1/10 (10.00%)  1
Overheating  [2]  0/10 (0.00%)  0 1/10 (10.00%)  1
Indicates events were collected by systematic assessment
[1]
One participant reported increased sweating and salivation following pyridostigmine administration.
[2]
One subject terminated head-up tilt intervention due to overheating.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Day 1 - No Drug Day 2 - Pyridostigmine Bromide
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/10 (0.00%)      0/10 (0.00%)    
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Jill M. Wecht
Organization: James J. Peters VA Medical Center
Phone: 7185849000 ext 3122
EMail: jm.wecht@va.gov
Layout table for additonal information
Responsible Party: Jill M. Wecht, Ed.D., James J. Peters Veterans Affairs Medical Center
ClinicalTrials.gov Identifier: NCT02307526     History of Changes
Other Study ID Numbers: WEC-11-04
First Submitted: May 21, 2014
First Posted: December 4, 2014
Results First Submitted: August 31, 2015
Results First Posted: July 21, 2017
Last Update Posted: July 21, 2017