The main objective of this pilot study is to assess the feasibility of internationally agreed pain test batteries in order:- To measure the overall facial response to pain in patients with HD- To explore the psychometric properties (inter- and…
ID
Source
Brief title
Condition
- Movement disorders (incl parkinsonism)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The feasibility of the different pain test batteries will be evaluated using a
screening tool including different items and cut-off scores.
Secondary outcome
The potential disturbances in the processing of pain in terms of facial
expression will be measured by the investigators by using the facial expression
items of the PAIC15. In addition, the intra- and interrater reliability of the
facial descriptors, body movements and vocalization items of the PAIC15 will be
assessed.
An exploratory objective is to assess the agreement (measurement error), in
other words how close scores for repeated measures are, will be assessed for
each outcome included in this study (e.g. facial response [PAIC15], pain
inhibition and facilitation).
Background summary
Huntington*s Disease (HD) is a autosomal-dominant neurodegenerative disease
causing motor (e.g., chorea) and non-motor symptoms (e.g., neurocognitive and
neuropsychiatric disturbances, and autonomic disturbances). Pain is a commonly
reported non-motor symptom in HD, with a prevalence of around 40% in the
manifest stage. Despite its high prevalence, patients with HD seem to be at
risk for undertreatment of pain as the disease progresses. This might be caused
by disturbances in the pain processing, which might influence the pain
experience and subsequently also the use of analgesics. Available experimental
studies in HD demonstrated indeed a significant prolongation of processing
noxious stimuli at spinal cord level in the manifest stage, compared to healthy
controls and individuals in the premanifest stage.
Pain management regimens rely on adequate pain assessment using valid and
reliable pain scales. Despite the availability of specifically developed and
internationally agreed pain test batteries to test disturbances in pain
processing and psychometric properties of pain scales, studies concerning these
topics in HD are scarce. In order to test the effect of HD on pain processing
and the psychometric properties of pain scales, the different pain test
batteries should be assessed on their feasibility in HD.
Study objective
The main objective of this pilot study is to assess the feasibility of
internationally agreed pain test batteries in order:
- To measure the overall facial response to pain in patients with HD
- To explore the psychometric properties (inter- and intrarater reliability) of
the facial descriptors, body movements, and vocalization items of an
observational pain scale, the Pain Assessment in Impaired Cognition Scale
(PAIC15), in patients with HD.
- To explore the prevalence and extent of endogenous pain modulation in the
early and middle stage of HD (facilitation, inhibition and the balance between
the two).
An exploratory objective is to assess the agreement (measurement error), in
other words how close scores for repeated measures are, will be assessed for
each outcome included in this study (e.g. facial response, pain inhibition and
facilitation).
Study design
An experimental, observational, cross-sectional study.
Study burden and risks
This study assesses the feasibility of internationally agreed pain test
battery, which will eventually provide the possibility to assess whether
disturbances in pain processing in HD are present and to test the psychometric
properties of an observational pain scale (PAIC15). The development of a
reliable pain scale and gaining fundamental knowledge about pain processing in
HD yield benefits for pain management regimens in HD.
The risk associated with this study is small and related to the discomfort
associated with the pain test batteries. The experimental setups are frequently
used and according to internationally agreed standards. In addition, the
devices used for inducing a painful stimulus will be set according to the
safety limits so that no physical harm can be inflicted on the patients.
The experimental setup allows us to collect unique data concerning pain
processing and psychometric properties of a pain scale in HD. Furthermore, the
combination of experimental data with clinical data results in a positive
balance of benefits compared to the small risk of this study.
Albinusdreef 2
Leiden 2333 ZA
NL
Albinusdreef 2
Leiden 2333 ZA
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study, an Adult- Onset
Huntington's Disease (HD) subject must meet the following criteria:
1. Genetically and clinically confirmed AoHD patients (>= 21 years, CAG repeats
>= 36; DCL of 4).
2. Good general health apart from having HD.
Note: Patients with chronic illness (e.g. hypertension) will be eligible if the
illness is stable and well-controlled according to the investigator that will
not impact the primary objectives of the study.
3. Able to give written informed consent.
Exclusion criteria
Potential Adult-Onset Huntington's Disease subject who meets any of the
following criteria will be excluded from participation of this study:
1. Juvenile and Pediatric Huntington*s Disease (age at onset <21 years).
2. Patients in the late stage of the disease (UDHRS-TFC score < 3).
3. Have medical, psychiatric, or other conditions (other than HD) that,
according to the investigator, may compromise the patient*s ability to
understand the patient information sheet, to give informed consent, to comply
with all study requirements, or to perform study assessments .(other than HD).
4. Have a history of (in the past year) or current (ab)use of any drug, alcohol
or medication that, in the opinion of the investigator, may seriously impact
interfere with the primary objectives of the study, according to the
investigator.
5. The presence of any sensorimotor neuropathy or any another disturbance
significantly disturbing the somatosensory systems), based on medical history
and/or clinical examination, that can interfere with the pain testing battery.
6. Women who are pregnant or breastfeeding.
Design
Recruitment
metc-ldd@lumc.nl
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 | NL84512.058.23 |