NCT04215939

Assessment of Vasomotion of People With Spinal Cord Injury

Completed NA Last updated 4 November 2020

What this trial tests

NA trial testing Cold environment participants with spinal cord injury in Spinal Cord Injuries in 16 participants. Completed in 25 July 2020.

Timeline

1 February 2019

Primary endpoint
25 July 2020

25 July 2020

Quick facts

Lead sponsor	Petros Dinas
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	factorial
Masking	none
Primary purpose	prevention
Enrollment	16
Start date	1 February 2019
Primary completion	25 July 2020
Estimated completion	25 July 2020
Sites	1 location across Greece

Drugs / interventions tested

• Cold environment participants with spinal cord injury
• Thermoneutral environment participants with spinal cord injury
• Warm environment participants with spinal cord injury
• Cold environment healthy male participants
• Thermoneutral environment healthy male participants
• Warm environment healthy male participants
• Cold environment healthy female participants
• Thermoneutral environment healthy female participants
• Warm environment healthy female participants

Conditions studied

• Spinal Cord Injuries — all drugs for Spinal Cord Injuries →
• Paraplegia — all drugs for Paraplegia →

Sponsor

Petros Dinas — full company profile →

Who can join

18 and older, any sex, with Spinal Cord Injuries or Paraplegia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Spinal cord injury (SCI), causes loss of supra-spinal control of the sympathetic nervous system and in some cases loss of sensation. As a result, people with SCI have impaired thermoregulatory system and the consequence of this thermoregulatory dysfunction, is that they cannot respond to the environmental changes. All the above lead to dysregulation in vasomotor tone, skeletal muscle shivering and sweating dysfunction. It is well known that skin plays an important role in regulating body temperature and regulates interactions between the environment and human body. A previous study in people with incomplete SCI showed that there are no differences in core temperature between patients with different level of mobility and sensation and different level of lesion, but there are significant differences in skin temperature. As mentioned above people with SCI have an impaired thermoregulatory capacity due to sudomotor and vasomotor dysfunction and that leads to greater thermal strain during rest and exercise when they expose to hot conditions. A previous study that performed exercise in people with SCI, highlights the fact that because of the impaired evaporative heat loss during exercise in hot conditions, they are in great risk. Because of this risk they propose different cooling strategies that promote evaporation such as fans and water spraying. It is therefore important to observe the thermoregulatory function (vasomotion and sudomotor) in people with SCI when they are exposed to different environments (cold, neutral and warm).

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Cardiovascular Stress and Characteristics of Cold-Induced Vasodilation in Women and Men during Cold-Water Immersion: A Randomized Control Study.
   Tsoutsoubi L, Ioannou LG, Mantzios K, Ziaka S, et al · · 2022 · cited 9× · PMID 36101432 · DOI 10.3390/biology11071054
2. Central versus peripheral mechanisms of cold-induced vasodilation: a study in the fingers and toes of people with paraplegia.
   Tsoutsoubi L, Ioannou LG, Alba BK, Cheung SS, et al · · 2023 · cited 2× · PMID 37005962 · DOI 10.1007/s00421-023-05175-7