Study of Behavioral Dysfunctions and Related Neuronal Correlates in Patients With Dystonia
D-DIST
1 other identifier
interventional
102
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 28, 2023
CompletedStudy Start
First participant enrolled
January 10, 2024
CompletedFirst Posted
Study publicly available on registry
February 16, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 10, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
October 10, 2025
CompletedMarch 31, 2026
March 1, 2026
2 months
December 28, 2023
March 26, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
montreal cognitive assessment
Study of cognitive functions in dystonic subjects, with particular reference to the mechanisms of memory, attention and executive functions
1 hour
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 Outcomes (1)
EEG power in alpha band
1 hour
Study Arms (2)
experimental group
EXPERIMENTALpatients with dystonia were submitted to a neuropsychological evaluation
control group
EXPERIMENTALhealthy patients were submitted to a neuropsychological evaluation
Interventions
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
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
partecipants were submitted to registration of electrical activity with EEG to study the EEG power in alpha band
Eligibility Criteria
You may qualify if:
- \> 18 years old;
- Informed consent;
- Montreal cognitive assessment \> 21;
You may not qualify if:
- Patients with cervical dystonia with anterocollis spasm;
- Sensory-motor deficits that can hinder neuropsychological assessment
- Contraindications to performing Magnetic Resonance Imaging
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
IRCCS Centro Neurolesi Bonino Pulejo
Messina, Messina, 98124, Italy
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
December 28, 2023
First Posted
February 16, 2024
Study Start
January 10, 2024
Primary Completion
March 10, 2024
Study Completion
October 10, 2025
Last Updated
March 31, 2026
Record last verified: 2026-03