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Thermoregulation and Cognition During Cool Ambient Exposure in Tetraplegia

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ClinicalTrials.gov Identifier: NCT02379156
Recruitment Status : Recruiting
First Posted : March 4, 2015
Last Update Posted : May 31, 2019
Sponsor:
Collaborator:
The Craig H. Neilsen Foundation
Information provided by (Responsible Party):
John Handrakis, PT, DPT, EdD, James J. Peters Veterans Affairs Medical Center

Brief Summary:

The ability to maintain normal core body temperature (Tcore = 98.6°F) is impaired in persons with a cervical spinal cord injury (tetraplegia). Despite the known deficits in the ability of persons with spinal cord injury (SCI) to maintain Tcore, and the effects of hypothermia to impair mental function in able-bodied (AB) persons, there has been no work to date addressing these issues in persons with tetraplegia.

Primary Aim: To determine if exposure of up to 2 hours to cool temperatures (64°F) causes Tcore to decrease in persons with tetraplegia, and if that decrease is associated with a decrease in cognitive function.

Primary Hypotheses: Based on our pilot data: (1) 66% of persons with tetraplegia and none of the matched controls will demonstrate a decline of 1.8°F in Tcore; (2) 80% of persons with tetraplegia and 30% of controls will have a decline of at least one T-score in Stroop Interference scores (a measure of executive function).

Secondary Aim: To determine the change in: (1) distal skin temperature, (2) metabolic rate, and (3) thermal sensitivity.

Secondary Hypothesis: Persons with tetraplegia will have less of a percent change in average distal skin temperatures and metabolic rate, and report lower thermal sensitivity ratings compared with AB controls.

Tertiary Aim: To determine if a 10 mg dose of an approved blood pressure-raising medicine (midodrine hydrochloride) will (1) reduce the decrease in Tcore and (2) prevent or delay the decline in cognitive performance in the group with tetraplegia compared to the exact same procedures performed on the day with no medicine (Visit 1) in that same group.

Tertiary Hypothesis: Through administering a one-time dose of midodrine, the medicine-induced decreased blood flow to the skin will lessen the decline in Tcore and prevent or delay the associated decline in cognitive performance compared to the changes in Tcore and cognitive performance during cool temperature exposure without midodrine in the same group with tetraplegia.


Condition or disease Intervention/treatment Phase
Tetraplegia Hypothermia Mild Cognitive Impairment Drug: Midodrine Hydrochloride Other: Cool Temperature Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Thermoregulation and Cognition During Cool Ambient Exposure in Tetraplegia
Study Start Date : April 2015
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cool Temperature Exposure / No Drug
Subjects are persons with tetraplegia: spinal cord lesion level C3 to T1, AIS levels A and B, ages 18-65 years or subjects are able-bodied controls matched for age and gender. Procedure is exposure to cool temperature (64° F) for up to 2 hours in a temperature-controlled room in order to assess the body's temperature-regulating mechanisms and any associated change in cognitive performance (Visit 1).
Other: Cool Temperature
Subjects will be exposed to a routinely encountered cool temperature (64° F) for up to to 2 hours depending on the vital signs (BP, HR, Tcore) and tolerance (comfort).
Other Name: 64° F

Experimental: Cool Temperature Exposure with Drug
Subjects are persons with tetraplegia who completed Visit 1 (no drug). Subjects are administered a 10 mg tablet of midodrine hydrochloride by a physician before being exposed to cool temperature (64° F) for up to 2 hours in a temperature-controlled room in order to assess the body's temperature-regulating mechanisms and any associated change in cognitive performance (Visit 2).
Drug: Midodrine Hydrochloride
Midodrine hydrochloride is an approved medication used to treat low blood pressure. We are using a standard dose of 10 mg (tablet) only one time to determine if the vascular-constricting effects of this drug will help keep warm blood closer to the body's core and improve the ability to maintain Tcore in a cool environment (off-label use). A physician will administer the drug once before the cool thermal challenge in subjects with tetraplegia only (Visit 2).
Other Names:
  • Gutron
  • ProAmatine
  • Amatine
  • Orvaten
  • Midodrine hydrochloride 10 mg tablet

Other: Cool Temperature
Subjects will be exposed to a routinely encountered cool temperature (64° F) for up to to 2 hours depending on the vital signs (BP, HR, Tcore) and tolerance (comfort).
Other Name: 64° F




Primary Outcome Measures :
  1. Core body temperature [ Time Frame: 120 minutes ]
    We will measure the effects of cool temperature (64°F) exposure, of up to 120 minutes, on the ability to maintain a constant Tcore (i.e., Tcore of 98.6°F) in both groups of subjects.


Secondary Outcome Measures :
  1. Cognitive performance [ Time Frame: 120 minutes ]
    Cognitive performance will be assessed using a neuropsychological battery consisting of measures of attention, working memory, processing speed, and executive function. We will assess cognitive performance 2 times (at the end of baseline and after cool challenge) in both groups of subjects.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Duration of SCI ≥1 year;
  • Level of SCI C3-T1, AIS A & B;
  • Age between 18 and 65 years.

Exclusion Criteria:

  • Evidence of sympathetic integrity below the lesion level by the skin axon-reflex vasodilatation (SkARV) test;
  • Known allergies to midodrine hydrochloride;
  • PMH of diagnosed heart, kidney, peripheral vascular, or cerebral vascular disease, or diabetes mellitus;
  • Hypertension (BP>140/90 mmHg);
  • Untreated thyroid disease;
  • Acute illness or infection;
  • Current smoker;
  • Pregnancy.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02379156


Contacts
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Contact: John P Handrakis, PT, DPT, EdD 718-584-9000 ext 5439 john.handrakis@va.gov
Contact: Oriana F Tascione, BS 718-584-9000 ext 2197 oriana.tascione@va.gov

Locations
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United States, New York
Center of Excellence for the Medical Consequences of SCI, James J Peters VAMC Recruiting
Bronx, New York, United States, 10468
Contact: John P Handrakis, PT, DPT, EdD    718-584-9000 ext 5439    john.handrakis@va.gov   
Contact: Oriana F Tascione, BS    718 584-9000 ext 2197    oriana.tascione@va.gov   
Sponsors and Collaborators
James J. Peters Veterans Affairs Medical Center
The Craig H. Neilsen Foundation
Investigators
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Principal Investigator: John P Handrakis, PT, DPT, EdD James J. Peters VAMC

Additional Information:
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Responsible Party: John Handrakis, PT, DPT, EdD, Research Health Science Specialist, James J. Peters Veterans Affairs Medical Center
ClinicalTrials.gov Identifier: NCT02379156     History of Changes
Other Study ID Numbers: HAN-14-045
315696 ( Other Grant/Funding Number: Craig H. Neilsen Foundation )
01589 ( Other Identifier: JJPVAMC IRB )
First Posted: March 4, 2015    Key Record Dates
Last Update Posted: May 31, 2019
Last Verified: May 2019

Keywords provided by John Handrakis, PT, DPT, EdD, James J. Peters Veterans Affairs Medical Center:
Quadriplegia
Spinal Cord Injury
Body Temperature Regulation
Mild Cognitive Impairment

Additional relevant MeSH terms:
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Quadriplegia
Hypothermia
Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Body Temperature Changes
Signs and Symptoms
Paralysis
Neurologic Manifestations
Nervous System Diseases
Midodrine
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Vasoconstrictor Agents
Adrenergic alpha-1 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action