Effect of Heat Exposure on Cognition in Persons With Tetraplegia

NCT02488824 | Completed Results

• 3 other identifiers: D1734-PHAN-15-01301613
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

The ability to maintain normal body temperature (Tcore) is impaired in persons with tetraplegia: subnormal Tcore and vulnerability to hypothermia (\<95 F) have been documented in this population after exposure to even mild environmental temperatures. However, no work to date has addressed the effect of subnormal Tcore on cognitive performance in persons with tetraplegia despite studies with able-bodied (AB) individuals that have documented progressive decline in various aspects of cognitive performance associated with the magnitude of the depression in Tcore. The investigators' study will confirm and extend their initial observations in persons with higher cord lesions who have subnormal Tcore to show that cognitive performance will be improved by raising Tcore to euthermic levels. This improvement should be associated with greater function and independence, reintegration into society, and an improved quality of life. Specific Aims: During exposure to 95 F for up to 120 minutes in the seated position, the investigators' aims are: Primary Specific Aim: To determine if a modest rise in Tcore to euthermic levels has a positive effect on cognitive performance (attention, working memory, processing speed, and executive function) in persons with higher-level spinal cord injury (SCI). Primary Hypothesis: Based on the investigators' pilot data: (1) 80% of persons with SCI will demonstrate an increase of 1 F in Tcore, while none of the AB controls will demonstrate such an increase; (2) 80% of persons with SCI will have an improvement of at least one T-score in Stroop Interference scores (a validated measure of executive function), while none of the AB controls will demonstrate a change in cognitive performance. Secondary Specific Aim: To determine changes in: (1) The average of distal skin temperatures; (2) Sweat rate; and (3) Subjective rating of thermal sensitivity. Secondary Hypothesis: Persons with SCI will have less of a percent change in average distal skin temperatures and sweat rate, and will report blunted ratings of thermal sensitivity compared to that of AB controls.

Conditions

Tetraplegia; Hypothermia; Mild Cognitive Impairment

Keywords

Quadriplegia; Paraplegia; Spinal Cord Injury; Body Temperature Regulation; Mild Cognitive Impairment

Outcome Measures

Primary Outcomes (2)

• Change in Core Body Temperature From Baseline to 120 Minutes Post Warm Challenge

  The investigators measured the effects of warm temperature (95 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 both groups of subjects. Core temperature was measured at baseline (thermoneutral) and after 120 minutes of warm temperature exposure (Warm Challenge). The change in core temperature from baseline to 120 minutes of Warm Challenge was calculated.

  From Baseline to 120 Minutes

• Change in Cognitive Performance From Baseline to 120 Minutes Post Warm Challenge

  Cognitive performance was assessed using a neuropsychological battery. Cognitive performance was assessed at 2 time points, at the end of baseline and after heat exposure (warm challenge) in both groups of subjects. The Stroop Word test measures processing speed. A T-Score of 50 means "0" difference of actual - predicted score (based on subject's age \& education level). T-Scores \<40 are considered "low"; T-Scores \>40 are considered "normal". Changes of 10 or greater are considered clinically significant. The lowest possible T-Score is 21; the highest possible T-Score is 80. The WAIS-IV Digit Span Sequencing measures auditory processing and working memory. Each test score is converted to a scaled score (M=10, SD=3) with higher scores considered better performance. The lowest possible scaled score is 1; the highest possible scaled score is 19.

  From Baseline to 120 Minutes

Secondary Outcomes (3)

• Change in Distal Skin Temperatures From Baseline to 120 Minutes Post Warm Challenge

  From Baseline to 120 Minutes

• Change in Sweat Rate From Baseline to 120 Minutes Post Warm Challenge

  From Baseline to 120 Minutes

• Change in Thermal Sensitivity From Baseline to 120 Minutes Post Warm Challenge

  From Baseline to 120 Minutes

Study Arms (2)

Warm Temperature Exposure in Tetraplegia

EXPERIMENTAL

Subjects are persons with higher-level spinal cord injury, levels C3 to T4, and ASIA Impairment Scale (AIS) level A and B, ages 18-68 years. Procedure is exposure to warm temperature (95 degrees Fahrenheit) 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

Procedure: Warm Temperature

Warm Temperature Exposure in Able-Bodied

ACTIVE COMPARATOR

Subjects are able-bodied controls matched with participants with tetraplegia for age and gender. Procedure is exposure to warm temperature (95 degrees Fahrenheit) 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

Procedure: Warm Temperature

Interventions

Warm Temperature PROCEDURE

Subjects will be exposed to a routinely encountered warm temperature (95 F) for up to to 2 hours, depending on their vital signs (BP, HR, Tcore) and tolerance (comfort).

Also known as: 95 F

Warm Temperature Exposure in Able-Bodied; Warm Temperature Exposure in 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:

• Duration of injury 1 year
• Level of SCI C3-T4, AIS A \& B
• Tcore at BL \<98.6 F (subnormal core body temperature)
• Euhydration
• Gender and age-matched ( 5 years) AB controls (between 18-68 years of age)

You may not qualify if:

• Known heart, kidney, peripheral vascular, or cerebral vascular disease
• High blood pressure
• History of traumatic brain injury or diagnosed cognitive impairment
• Untreated thyroid disease
• Diabetes mellitus
• Acute illness or infection
• Dehydration
• Smoking
• Pregnancy
• Broken, inflamed, or otherwise fragile skin

Sponsors & Collaborators

• VA Office of Research and Development: lead
• James J. Peters Veterans Affairs Medical Center: collaborator

Study Sites (1)

James J. Peters VA Medical Center, Bronx, NY

The Bronx, New York, 10468, United States

Location

Related Links

• Click here for more information about this study: Effect of Heat Exposure on Cognition in Persons with Higher Cord Lesions

MeSH Terms

Conditions

Quadriplegia; Hypothermia; Cognitive Dysfunction; Paraplegia; Spinal Cord Injuries

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

Results Point of Contact

• Title: Dr John Handrakis
• Organization: VAORD

John.Handrakis@va.gov

(718) 584-9000

Study Officials

• John Philip Handrakis, PT DPT EdD

  James J. Peters Veterans Affairs Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2015
• First Posted: July 2, 2015
• Study Start: April 1, 2015
• Primary Completion: September 4, 2018
• Study Completion: September 4, 2018
• Last Updated: November 18, 2019
• Results First Posted: November 1, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)