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Body Temperature in Persons With Tetraplegia When Exposed to Cold

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ClinicalTrials.gov Identifier: NCT01822535
Recruitment Status : Completed
First Posted : April 2, 2013
Results First Posted : March 4, 2016
Last Update Posted : March 4, 2016
Sponsor:
Information provided by (Responsible Party):
John Handrakis, PT, DPT, EdD, James J. Peters Veterans Affairs Medical Center

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Factorial Assignment;   Masking: None (Open Label)
Conditions: Tetraplegia
Hypothermia
Mild Cognitive Impairment
Intervention: Drug: Midodrine hydrochloride

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Tetraplegia Lesion level C3-T1, American Spinal Injury Association (ASIA) impairment levels A and B, ages 18-68 years
Able-bodied (AB) Age- and gender-matched to individuals with tetraplegia.

Participant Flow for 2 periods

Period 1:   Visit 1 - Tetraplegia and Able-Bodied
    Tetraplegia   Able-bodied (AB)
STARTED   17   13 
COMPLETED   11   11 
NOT COMPLETED   6   2 
Adverse Event                2                0 
Withdrawal by Subject                4                2 

Period 2:   Visit 2 - Tetraplegia Only - Drug
    Tetraplegia   Able-bodied (AB)
STARTED   11 [1]   0 [2] 
COMPLETED   10   0 
NOT COMPLETED   1   0 
Adverse Event                1                0 
[1] These subjects were individuals who completed Visit 1 of testing.
[2] Able-bodied subjects were not enrolled for a second visit.



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Tetraplegia Lesion level T1 and above, ASIA levels A and B, ages 18-68 years
Able-bodied Age- and gender-matched to individuals with tetraplegia.
Total Total of all reporting groups

Baseline Measures
   Tetraplegia   Able-bodied   Total 
Overall Participants Analyzed 
[Units: Participants]
 11   11   22 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   10   11   21 
>=65 years   1   0   1 
Gender 
[Units: Participants]
     
Female   0   0   0 
Male   11   11   22 
Region of Enrollment 
[Units: Participants]
     
United States   11   11   22 


  Outcome Measures

1.  Primary:   Visit 1: Percent Change in Core Body Temperature   [ Time Frame: Baseline, Up to 2 hours ]

2.  Primary:   Visit 2: Percent Change in Core Body Temperature With Midodrine   [ Time Frame: Baseline, Baseline Post-midodrine, Up to 2 hours ]

3.  Secondary:   Visit 1: Percent Changes in Cognitive Performance - Stroop Interference   [ Time Frame: Baseline, Up to 2 hours ]

4.  Secondary:   Visit 1: Percent Changes in Cognitive Performance - Delayed Recall   [ Time Frame: Baseline, Up to 2 hours ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data

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.



  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. John P. Handrakis
Organization: James J. Peters VA Medical Center
phone: 718-584-9000 ext 5439
e-mail: john.handrakis@va.gov


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: John Handrakis, PT, DPT, EdD, James J. Peters Veterans Affairs Medical Center
ClinicalTrials.gov Identifier: NCT01822535     History of Changes
Other Study ID Numbers: 01374
First Submitted: March 21, 2013
First Posted: April 2, 2013
Results First Submitted: November 23, 2015
Results First Posted: March 4, 2016
Last Update Posted: March 4, 2016