Body Temperature in Persons With Tetraplegia When Exposed to Cold

NCT01822535 | Completed Phase 4 Results

• 1 other identifier: 01374
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Tetraplegia; Hypothermia; Mild Cognitive Impairment

Keywords

Quadriplegia; Spinal Cord Injuries; Body Temperature Regulation; Mild Cognitive Impairment

Outcome Measures

Primary Outcomes (2)

• Visit 1: Percent Change in Core Body Temperature

  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 through comparing the percent changes in core body temperatures between groups from baseline to after cool exposure.

  Baseline, Up to 2 hours

• Visit 2: Percent Change in Core Body Temperature With Midodrine

  We will test the effects of midodrine on the ability to maintain a constant body temperature (e.g., core temperature of 98.6°F) after exposure to cool temperatures (64°F) in persons with tetraplegia through comparing the percent changes in core body temperature during visit 1 to percent changes in core body temperature during visit 2.

  Baseline, Baseline Post-midodrine, Up to 2 hours

Secondary Outcomes (2)

• Visit 1: Percent Changes in Cognitive Performance - Stroop Interference

  Baseline, Up to 2 hours

• Visit 1: Percent Changes in Cognitive Performance - Delayed Recall

  Baseline, Up to 2 hours

Study Arms (3)

No Drug: Tetraplegia

NO INTERVENTION

Tetraplegia: Lesion level T1 and above, American Spinal Injury Association (ASIA) impairment levels A and B, ages 18-68 years. Exposure of up to 2 hours in a cool room.

No Drug: AB Controls

NO INTERVENTION

AB Controls: Matched for age and gender to subjects with tetraplegia. Exposure of up to 2 hours in a cool room.

Drug (midodrine): Tetraplegia

EXPERIMENTAL

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

Interventions

Midodrine hydrochloride DRUG

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)

Also known as: Midodrine hydrochloride 10 mg tablet, Amatine, ProAmatine, Gutron

Drug (midodrine): Tetraplegia

Eligibility Criteria

• Age: 18 Years - 68 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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)

You may not qualify if:

• (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

Sponsors & Collaborators

• James J. Peters Veterans Affairs Medical Center: lead

Study Sites (1)

Center of Excellence for the Medical Consequences of SCI, JJP VAMC, 7A-13

The Bronx, New York, 10468, United States

Location

Related Publications (1)

• Handrakis JP, Liu SA, Rosado-Rivera D, Krajewski M, Spungen AM, Bang C, Swonger K, Bauman WA. Effect of Mild Cold Exposure on Cognition in Persons with Tetraplegia. J Neurotrauma. 2015 Aug 1;32(15):1168-75. doi: 10.1089/neu.2014.3719. Epub 2015 Mar 31.

  PMID: 25531297 DERIVED

Related Links

• Link to Center of Excellence Research Center. Look under Research to find Thermoregulation

MeSH Terms

Conditions

Quadriplegia; Hypothermia; Cognitive Dysfunction; Spinal Cord Injuries

Interventions

Midodrine; Tablets

Condition Hierarchy (Ancestors)

Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Temperature Changes; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Spinal Cord Diseases; Central Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Dosage Forms; Pharmaceutical Preparations

Limitations and Caveats

Did not assess cognitive performance a third time, after Tcore in the group with tetraplegia had returned to baseline levels. Study had a small sample size, and only included males.

Results Point of Contact

• Title: Dr. John P. Handrakis
• Organization: James J. Peters VA Medical Center

john.handrakis@va.gov

718-584-9000

Study Officials

• John P Handrakis, PT, DPT, EdD

  James J Peters VA MC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: FACTORIAL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Health Science Specialist

Study Record Dates

• First Submitted: March 21, 2013
• First Posted: April 2, 2013
• Study Start: July 1, 2011
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: March 4, 2016
• Results First Posted: March 4, 2016

Record last verified: 2016-02

Locations

US (1)