Body Temperature in Persons With Tetraplegia When Exposed to Cold

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
John Handrakis, PT, DPT, EdD, James J. Peters Veterans Affairs Medical Center
ClinicalTrials.gov Identifier:
NCT01822535
First received: March 21, 2013
Last updated: March 6, 2015
Last verified: March 2015
  Purpose

The ability to maintain normal body core temperature (Tcore = 98.6°F) is impaired in persons with tetraplegia. Despite the known challenges to 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.

The aim of this study is to determine if exposure of up to 2 hrs to cool temperatures (64°F) causes body core temperature to decrease in persons with tetraplegia and if that decrease is related to a decrease in mental performance.

After sitting in a cool (64°F) room for up to 2 hours the investigators hypotheses are:

Hypotheses (1): Tcore of most of the persons with tetraplegia will decline approximately 1.8°F (e.g., 98.6 to 96.8°F) while Tcore of controls will not decline at all; (2) Most of the persons with tetraplegia will show a decline in mental performance (memory or clear-headedness) while only some of AB controls will show a decline.

The second aim of this study is to determine if a 10 mg dose of an approved blood pressure raising medicine (midodrine hydrochloride) will (1) reduce the decrease in body core temperature and (2) prevent or delay the decline in mental performance in the group with tetraplegia compared to the exact same procedures performed on the day with no medicine (Visit 1) in the same group.

Hypotheses (3 & 4): The changes in blood flow to the skin caused by taking a one-time dose of midodrine will lessen the decline in Tcore and prevent or delay the decline in mental performance compared to the changes in Tcore and mental performance during cool temperature exposure without midodrine in the group with tetraplegia.


Condition Intervention Phase
Tetraplegia
Hypothermia
Mild Cognitive Impairment
Drug: Midodrine hydrochloride
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: Open Label
Official Title: Core Temperature During Cold Exposure in Persons With Tetraplegia

Resource links provided by NLM:


Further study details as provided by James J. Peters Veterans Affairs Medical Center:

Primary Outcome Measures:
  • Core body temperature [ Time Frame: 2 hours ] [ Designated as safety issue: Yes ]
    We will test the effects of cool temperature (64°F) exposure, of up to 120 minutes, on the ability to maintain a constant body temperature (e.g., core temperature of 98.6°F) in persons with tetraplegia.


Secondary Outcome Measures:
  • Cognitive performance [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
    Cognitive performance will be evaluated as a composite measure consisting of assessments of attention, working memory, processing speed and executive function. We will measure the change in cognitive performance in persons with tetraplegia after exposure to a cool environment (64°F) of up to 120 min in the seated position.


Estimated Enrollment: 30
Study Start Date: July 2011
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: No Drug
Tetraplegia: Lesion level T1 and above, ASIA levels A and B, ages 18-68 years. AB Controls: Matched for age and gender. Exposure of up to 2 hours in a cool room.
Experimental: Drug (midodrine)
Persons with tetraplegia who completed Visit 1 (no drug). Participants are administered midodrine hydrochloride (10 mg tablet) by a physician before exposure of up to 2 hours in a cool room. (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 effects of this drug improve the ability to maintain body core temperature 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:
  • Midodrine hydrochloride 10 mg tablet
  • Amatine
  • ProAmatine
  • Gutron

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 68 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • (1) Between 18 and 68 years of age;
  • (2) Duration of injury ≥ 1 year; (2) Level of SCI C3-T1;
  • (3) Euhydration (subjects will be instructed to avoid caffeine and alcohol, maintain normal salt and water intake, and avoid strenuous exercise for 24 hours prior to study)

Exclusion Criteria:

  • (1) Known coronary heart, kidney, peripheral vascular or cerebral vascular disease;
  • (2) High blood pressure;
  • (3) Untreated thyroid disease;
  • (4) Diabetes mellitus;
  • (5) Acute illness or infection;
  • (6) Dehydration;
  • (7) Known allergies to midodrine hydrochloride;
  • (8) Smoking;
  • (9) Pregnancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01822535

Locations
United States, New York
Center of Excellence for the Medical Consequences of SCI, JJP VAMC, 7A-13
Bronx, New York, United States, 10468
Sponsors and Collaborators
James J. Peters Veterans Affairs Medical Center
Investigators
Principal Investigator: John P Handrakis, PT, DPT, EdD James J Peters VA MC
  More Information

Additional Information:
No publications provided

Responsible Party: John Handrakis, PT, DPT, EdD, Research Health Science Specialist, James J. Peters Veterans Affairs Medical Center
ClinicalTrials.gov Identifier: NCT01822535     History of Changes
Other Study ID Numbers: 01374
Study First Received: March 21, 2013
Last Updated: March 6, 2015
Health Authority: United States: Federal Government

Keywords provided by James J. Peters Veterans Affairs Medical Center:
Quadriplegia
Spinal Cord Injuries
Body Temperature Regulation
Mild Cognitive Impairment

Additional relevant MeSH terms:
Cognition Disorders
Hypothermia
Mild Cognitive Impairment
Quadriplegia
Body Temperature Changes
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Nervous System Diseases
Neurologic Manifestations
Paralysis
Signs and Symptoms
Midodrine
Adrenergic Agents
Adrenergic Agonists
Adrenergic alpha-1 Receptor Agonists
Adrenergic alpha-Agonists
Autonomic Agents
Cardiovascular Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sympathomimetics
Therapeutic Uses
Vasoconstrictor Agents

ClinicalTrials.gov processed this record on April 23, 2015