To study the quantitative and qualitative relationship between a heat stimulus and the vasomotor response in healthy subjects and to determine the feasibility of this measurement setup for patients.
ID
Source
Brief title
Condition
- Other condition
- Peripheral neuropathies
Synonym
Health condition
thermoregulatie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is the reliability and repeatability of the heat
evoked vasomotor response, which will be measured using 1) Pulse Transit Time
(PTT), 2) Laser Doppler, and 3) videothermography.
Secondary outcome
-
Background summary
Small nerve fiber neuropathy is a common disorder, characterized by dysfunction
of the small nerve fibers often leading to neuropathic pain. Neuropathic pain
has a large socio-economic impact and an enormous influence on quality of life.
The gold standard for diagnosing small fiber dysfunction is skin biopsy, which
is invasive, labor intensive and had limited accuracy. Therefore there is
clinical demand for a simple non-invasive test to objectively quantify small
fiber dysfunction. Such a test would enable early diagnosis and allow early
treatment to potentially delay chronification.
Besides the pain system, small fiber dysfunction also affects the local blood
flow system. Skin blood flow is modulated by thermoregulation and responds to
local changes in temperature. Local warming (e.g. on a hot summer day, during
physical exercise, or by an external heat source) induces vasodilation and
increases skin blood flow. The heat induced change in blood flow (vasomotor
response) can be assessed with several standard techniques, e.g. laser Doppler
and videothermography. Application of temperature stimuli together with the
measurements of blood flow enable quantification of the vasomotor response and
thereby provide information on the thermoregulatory system. However, an
effective method for applying temperature stimuli in combination with those
measurement techniques is lacking.
Study objective
To study the quantitative and qualitative relationship between a heat stimulus
and the vasomotor response in healthy subjects and to determine the feasibility
of this measurement setup for patients.
Study design
A prospective, observational, single centre study conducted in the Erasmus
Medical Centre.
Intervention
A sequence of safe non-contact infrared heat pulses applied to the skin by an
external heat source to induce vasomotor response.
Study burden and risks
The measurements are without risk, they are all non-invasive. Application of
the heat stimulus imposes only a minor risk because we stay within the EU
safety regulations; risk of skin damage is negligible.
Dr Molewaterplein 50
Rotterdam 3015GE
NL
Dr Molewaterplein 50
Rotterdam 3015GE
NL
Listed location countries
Age
Inclusion criteria
Healthy adult volunteers, aged 18-35 years or 50-60 years old.
Exclusion criteria
Cardiovascular disease (e.g. hypertension, diabetes mellitus) or other diseases which affect vasomotor functioning.
Injuries to site of measurement
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL33823.078.10 |