TetraplegiaNCT02488824
Effect of Heat Exposure on Cognition in Persons With Tetraplegia
A study testing Warm Temperature in people with Tetraplegia and Hypothermia, run by VA Office of Research and Development at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 68 yearsHealthy volunteers can take part
- Conditions the study is for
- Tetraplegia, Hypothermia, Mild Cognitive Impairment
- What is being tested?
- Warm Temperature
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2015to 4 Sep 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 68 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 10Show fewer
- Dehydration
- Smoking
- Pregnancy
- Broken, inflamed, or otherwise fragile skin
Trial locations and contacts
1 site in 1 country.
United States1 site
James J. Peters VA Medical Center, Bronx, NY
The Bronx, New York, 10468
About this study
Official title: Effect of Heat Exposure on Cognition in Persons With Higher Cord Lesions
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:
Read more
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.
Read the detailed description
This study will investigate the physiological and cognitive responses to warm exposure in persons with SCI who have subnormal Tcore and in AB persons who are euthermic. The positive effect that an increase in Tcore will be expected to have on cognitive performance, specifically working memory and executive function, will be demonstrated. These two areas of cognitive performance are vital for the ability to optimally care for one's self, at which persons with higher cord lesions must excel in order to ensure health, and for the ability to attain the maximal degree of independence possible.
Preparation for Study Visits: Subjects will be instructed to avoid caffeine and alcohol, maintain normal salt and water intake, and avoid strenuous exercise for 24 hours prior to the study. Subjects will be asked to eat a light, standard meal (plain bagel or 2 pieces of toast) 2 hours prior to their visit. Subjects will be asked to empty their bladders prior to their visit and again upon arrival, if needed. Subjects will wear minimal clothing during the study to maximize skin exposure to the warm temperature.
Instrumentation: Subjects with SCI will be asked to remain in their wheelchairs and AB controls will be placed in a manual wheelchair where they will remain seated and relatively still for the duration of the study visit. A thin, flexible rectal sensor will be placed 4 inches beyond the anal sphincter for Tcore collection, and skin sensors will be secured at 15 sites above and below the level of lesion for collection of skin temperature (Tsk). Sweat collection capsules will be placed on the left bicep, the left forearm, the left thigh and the left calf for measurement of sweat rate by QSweat methodology (QS). Laser Doppler flowmetry will be used to measure changes in microvascular perfusion (MVP) by placing a Doppler probe on the back of both hands and both feet to confirm peripheral blood vessel dilation. An automated blood pressure cuff will be placed above the left elbow to measure brachial BP.
Baseline Collection (BL): At the end of a 30-minute acclimation period at 81 F, a baseline collection of the following parameters will be performed for 15 minutes: Tcore and Tsk will be continuously monitored; BP, heart rate (HR), and thermal sensitivity (TS) will be measured in 10-minute intervals; and MVP and QS will be measured in 15-minute intervals. After 15 minutes, a battery of cognitive tests will be administered to establish baseline cognitive performance.
Thermal Challenge (Heat): Following completion of the BL period, subjects will be wheeled into a pre-heated (95 F) thermal chamber for up to 120 minutes or until Tcore increases 1 F. Tcore and Tsk will be continuously monitored to ensure subjects' safety throughout the protocol, while HR, BP, and TS will be assessed at 10-minute intervals. MVP and QS will be measured every 30 minutes. The battery of cognitive tests utilized during BL collection will be administered when Tcore increases 1 F from BL values (for subjects with tetraplegia) or after 100 minutes (for controls) to determine any change in cognition after exposure to 95 F. An increase in Tcore 1 F, significant changes in BP, or subject discomfort will result in termination of the protocol.
- Conditions
- Tetraplegia, Hypothermia, Mild Cognitive Impairment
- Being tested
- Warm Temperature
- Keywords
- Quadriplegia, Paraplegia, Spinal Cord Injury, Body Temperature Regulation, Mild Cognitive Impairment
- Medical subject headings
- Quadriplegia, Hypothermia, Cognitive Dysfunction, Paraplegia, Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Warm TemperatureProcedure or surgery
Also called 95 F
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).
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Procedure: Warm Temperature |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: From Baseline to 120 Minutes
Secondary outcomes (3)
Change in Distal Skin Temperatures 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 change in distal skin temperatures in the seated position.
Measured: From Baseline to 120 Minutes
Change in Sweat Rate 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 change in sweat rate in the seated position.
Measured: From Baseline to 120 Minutes
Change in Thermal Sensitivity 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 change in thermal sensitivity in the seated position on the 9-Point Thermal sensation scale (+4=very hot, +3=hot, +2=warm, +1=slightly warm, 0=neutral, -1=slightly cool, -2=cool, -3=cold, -4=very cold). A higher score means the subject feels hotter, which, for the identical heat challenge, means less effective thermoregulation.
Measured: From Baseline to 120 Minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2015 (estimated)
- Study start1 Apr 2015
- Primary completion4 Sep 2018
- Study completion4 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for TetraplegiaStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- James J. Peters Veterans Affairs Medical Center
- Responsible party
- Sponsor
- Investigators
- John Philip Handrakis, PT DPT EdD, Principal investigator, James J. Peters Veterans Affairs Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02488824
- Sponsor's protocol ID
- D1734-P
- Other IDs
- HAN-15-013, 01613
- Status last verified
- Nov 2019
- First submitted
- 20 Apr 2015
- Last updated
- 18 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Heat Exposure on Cognition in Persons With Higher Cord Lesions
- ClinicalTrials.gov ID
- NCT02488824
- Acronym / sponsor ID
- D1734-P
- Conditions
- Tetraplegia, Hypothermia, Mild Cognitive Impairment
- Keywords
- Quadriplegia, Paraplegia, Spinal Cord Injury, Body Temperature Regulation, Mild Cognitive Impairment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- James J. Peters Veterans Affairs Medical Center
- Study start
- 1 Apr 2015 (actual)
- Primary completion
- 4 Sep 2018 (actual)
- Study completion
- 4 Sep 2018 (actual)
- First posted
- 2 Jul 2015 (estimated)
- Results
- Posted 1 Nov 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study will investigate the physiological and cognitive responses to warm exposure in persons with SCI who have subnormal Tcore and in AB persons who are euthermic. The positive effect that an increase in Tcore will be expected to have on cognitive performance, specifically working memory and executive function, will be demonstrated. These two areas of cognitive performance are vital for the ability to optimally care for one's self, at which persons with higher cord lesions must excel in order to ensure health, and for the ability to attain the maximal degree of independence possible.
Preparation for Study Visits: Subjects will be instructed to avoid caffeine and alcohol, maintain normal salt and water intake, and avoid strenuous exercise for 24 hours prior to the study. Subjects will be asked to eat a light, standard meal (plain bagel or 2 pieces of toast) 2 hours prior to their visit. Subjects will be asked to empty their bladders prior to their visit and again upon arrival, if needed. Subjects will wear minimal clothing during the study to maximize skin exposure to the warm temperature.
Instrumentation: Subjects with SCI will be asked to remain in their wheelchairs and AB controls will be placed in a manual wheelchair where they will remain seated and relatively still for the duration of the study visit. A thin, flexible rectal sensor will be placed 4 inches beyond the anal sphincter for Tcore collection, and skin sensors will be secured at 15 sites above and below the level of lesion for collection of skin temperature (Tsk). Sweat collection capsules will be placed on the left bicep, the left forearm, the left thigh and the left calf for measurement of sweat rate by QSweat methodology (QS). Laser Doppler flowmetry will be used to measure changes in microvascular perfusion (MVP) by placing a Doppler probe on the back of both hands and both feet to confirm peripheral blood vessel dilation. An automated blood pressure cuff will be placed above the left elbow to measure brachial BP.
Baseline Collection (BL): At the end of a 30-minute acclimation period at 81 F, a baseline collection of the following parameters will be performed for 15 minutes: Tcore and Tsk will be continuously monitored; BP, heart rate (HR), and thermal sensitivity (TS) will be measured in 10-minute intervals; and MVP and QS will be measured in 15-minute intervals. After 15 minutes, a battery of cognitive tests will be administered to establish baseline cognitive performance.
Thermal Challenge (Heat): Following completion of the BL period, subjects will be wheeled into a pre-heated (95 F) thermal chamber for up to 120 minutes or until Tcore increases 1 F. Tcore and Tsk will be continuously monitored to ensure subjects' safety throughout the protocol, while HR, BP, and TS will be assessed at 10-minute intervals. MVP and QS will be measured every 30 minutes. The battery of cognitive tests utilized during BL collection will be administered when Tcore increases 1 F from BL values (for subjects with tetraplegia) or after 100 minutes (for controls) to determine any change in cognition after exposure to 95 F. An increase in Tcore 1 F, significant changes in BP, or subject discomfort will result in termination of the protocol.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Warm Temperature Exposure in Tetraplegia | Experimental | Procedure: Warm TemperatureSubjects 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 |
| Warm Temperature Exposure in Able-Bodied | Active comparator | Procedure: Warm TemperatureSubjects 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 |
Who may qualify
- Ages
- 18 to 68 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Warm TemperatureAlso: 95 FSubjects 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). | Procedure or surgery | Warm Temperature Exposure in Able-Bodied, Warm Temperature Exposure in Tetraplegia |
Primary outcome
Change in Core Body Temperature From Baseline to 120 Minutes Post Warm Challenge
Time frame: From Baseline to 120 Minutes
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.
Change in Cognitive Performance From Baseline to 120 Minutes Post Warm Challenge
Time frame: From Baseline to 120 Minutes
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.
3 secondary outcomes
Change in Distal Skin Temperatures From Baseline to 120 Minutes Post Warm Challenge
Time frame: From Baseline to 120 Minutes
Change in Sweat Rate From Baseline to 120 Minutes Post Warm Challenge
Time frame: From Baseline to 120 Minutes
Change in Thermal Sensitivity From Baseline to 120 Minutes Post Warm Challenge
Time frame: From Baseline to 120 Minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Click here for more information about this study: Effect of Heat Exposure on Cognition in Persons with Higher Cord LesionsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Philip Handrakis, PT DPT EdD principal investigator
James J. Peters Veterans Affairs Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Warm Temperature in people with Tetraplegia and Hypothermia, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Core Body Temperature From Baseline to 120 Minutes Post Warm Challenge (time frame: From Baseline to 120 Minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2019.