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CompletedNCT06264063D-DISTUpdated Mar 31, 2026

Study of Behavioral Dysfunctions and Related Neuronal Correlates in Patients With Dystonia

An interventional study of control group and experimental group in Dystonia, Neurologic Disorder and NEUROSCIENCE, sponsored by IRCCS Centro Neurolesi Bonino Pulejo. Completed at 1 site in Italy. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-31.

Sponsored by IRCCS Centro Neurolesi Bonino Pulejo · Not applicable, Interventional, and Screening

Phase
Not applicable
Study type
Interventional
Enrollment
102
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

Read the detailed 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

02

Conditions studied

  • Dystonia
  • Neurologic Disorder
  • NEUROSCIENCE
03

In context

Dystonia

319 studies on the registry are indexed under Dystonia; 56 are open to participants now.

This study's enrollment of 102 is above the median of 32 across 181 interventional studies indexed under Dystonia.

Browse Dystonia studies →

Lead sponsor

IRCCS Centro Neurolesi Bonino Pulejo is the lead sponsor of 67 studies on the registry; 32 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • > 18 years old;
  • Informed consent;
  • Montreal cognitive assessment > 21;

Exclusion criteria

Exclusion Criteria:

  • Patients with cervical dystonia with anterocollis spasm;
  • Sensory-motor deficits that can hinder neuropsychological assessment
  • Contraindications to performing Magnetic Resonance Imaging
05

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
102 participants (actual)

Study arms

  • Experimental
    experimental group

    patients with dystonia were submitted to a neuropsychological evaluation

    Behavioral: experimental group · Diagnostic Test: EEG power in alpha band

  • Experimental
    control group

    healthy patients were submitted to a neuropsychological evaluation

    Behavioral: control group · Diagnostic Test: EEG power in alpha band

Interventions

  • Behavioralcontrol 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

  • Behavioralexperimental 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 testEEG power in alpha band

    partecipants were submitted to registration of electrical activity with EEG to study the EEG power in alpha band

06

What researchers measure

Primary outcomes

  1. montreal cognitive assessment

    Study of cognitive functions in dystonic subjects, with particular reference to the mechanisms of memory, attention and executive functions

    Time frame: 1 hour

  2. 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

    Time frame: 1 hour

Secondary outcomes

  1. EEG power in alpha band

    Connectivity analysis of neuronal substrates related to higher order cognitive alterations and the power of alpha band

    Time frame: 1 hour

07

Study locations

1 site
  • IRCCS Centro Neurolesi Bonino Pulejo
    Messina, Messina 98124, Italy
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 31, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06264063
Lead sponsor
IRCCS Centro Neurolesi Bonino Pulejo
Responsible party
Caterina Formica (Principal Investigator, IRCCS Centro Neurolesi Bonino Pulejo) — Principal investigator
First posted
Feb 16, 2024
Start date
Jan 10, 2024
Primary completion
Mar 10, 2024
Completion
Oct 10, 2025
Last update
Mar 31, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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