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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


Recruitment information / eligibility

Status Recruiting
Enrollment 102
Est. completion date October 10, 2025
Est. primary completion date March 10, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria: - > 18 years old; - Informed consent; - Montreal cognitive assessment > 21; Exclusion Criteria: - Patients with cervical dystonia with anterocollis spasm; - Sensory-motor deficits that can hinder neuropsychological assessment - Contraindications to performing Magnetic Resonance Imaging

Study Design


Intervention

Behavioral:
control group
the investigators have to assess the neuropsychological and psychological profile with specific questionnaire that evaluated the moral index, presence of obsessive and compulsive disorders and Montreal Cognitive Assessment to evaluate cognitive functions
experimental group
the investigators have to assess the neuropsychological and psychological profile with specific questionnaire that evaluated the moral index, presence of obsessive and compulsive disorders and Montreal Cognitive Assessment to evaluate cognitive functions
Diagnostic Test:
EEG power in alpha band
partecipants were submitted to registration of electrical activity with EEG to study the EEG power in alpha band

Locations

Country Name City State
Italy IRCCS Centro Neurolesi Bonino Pulejo Messina

Sponsors (1)

Lead Sponsor Collaborator
IRCCS Centro Neurolesi "Bonino-Pulejo"

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary montreal cognitive assessment Study of cognitive functions in dystonic subjects, with particular reference to the mechanisms of memory, attention and executive functions 1 hour
Primary Beck depression inventory Study of affective functions in dystonic subjects, with particular reference to the mechanisms of mood and evaluating the presence of depressive symptoms 1 hour
Secondary EEG power in alpha band Connectivity analysis of neuronal substrates related to higher order cognitive alterations and the power of alpha band 1 hour
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