Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT06264063 |
Other study ID # |
D-DIST |
Secondary ID |
|
Status |
Recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
January 10, 2024 |
Est. completion date |
October 10, 2025 |
Study information
Verified date |
January 2024 |
Source |
IRCCS Centro Neurolesi "Bonino-Pulejo" |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
Dystonias represent hyperkinetic movement disorders characterized by protracted muscle
contractions, such as to cause torsional movements and anomalous postures in different parts
of the body. Although they occur more often in a focal form (blepharospasm, oromandibular
dystonia, cervical dystonia, laryngeal dystonia, attitudinal cramps of the limbs) than
segmental (involvement of several contiguous muscle groups, e.g. facial muscles and neck
muscles), they are nevertheless capable of significantly influencing the quality of life,
with consequent social and health costs. Although described as a predominantly motor
disorder, the presence of non-motor symptoms in dystonias associated with alteration of the
fronto-striatal circuits is increasingly recognized. Neuroimaging studies have highlighted
that the striatum and, more specifically, striatal dopamine, is involved in high cognitive
processes such as attention, reward-based learning and decision making. Clinical conditions
associated with cortico-striatal circuit dysfunction and abnormal meso-striatal or
meso-cortical dopamine transmission also appear to influence temporal estimation, delay
discounting, showing an impulsive preference for immediate rewards over delayed
gratification.
Based on these premises, the present project aims to evaluate the cognitive and affective
aspects of dystonias, in line with neuroimaging research documenting structural and
functional dysfunctions in the respective brain regions.
Description:
Dystonias represent hyperkinetic movement disorders characterized by protracted muscle
contractions, such as to cause torsional movements and anomalous postures in different parts
of the body. Although they occur more often in a focal form (blepharospasm, oromandibular
dystonia, cervical dystonia, laryngeal dystonia, attitudinal cramps of the limbs) than
segmental (involvement of several contiguous muscle groups, e.g. facial muscles and neck
muscles), they are nevertheless capable of significantly influencing the quality of life,
with consequent social and health costs. Although described as a predominantly motor
disorder, the presence of non-motor symptoms in dystonias associated with alteration of the
fronto-striatal circuits is increasingly recognized. Neuroimaging studies have highlighted
that the striatum and, more specifically, striatal dopamine, is involved in high cognitive
processes such as attention, reward-based learning and decision making. Clinical conditions
associated with cortico-striatal circuit dysfunction and abnormal meso-striatal or
meso-cortical dopamine transmission also appear to influence temporal estimation, delay
discounting, showing an impulsive preference for immediate rewards over delayed
gratification.
Based on these premises, the present project aims to evaluate the cognitive and affective
aspects of dystonias, in line with neuroimaging research documenting structural and
functional dysfunctions in the respective brain regions.
The study aims to investigate the neurocognitive profile in patients with dystonia. In
particular, investigators will evaluate the correlation between the alterations of the
subcortical areas and the cognitive and affective functions involved in the processes of
evaluating risk, reward and impulsivity.
Primary Objectives:
Study of cognitive and affective functions in dystonic subjects, with particular reference to
the mechanisms of reward learning, inhibitory control and impulsivity.
Secondary objectives:
Connectivity analysis of neuronal substrates related to higher order cognitive alterations