NCT06264063

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 28, 2023

Completed
13 days until next milestone

Study Start

First participant enrolled

January 10, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 16, 2024

Completed
23 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 10, 2024

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2025

Completed
Last Updated

March 31, 2026

Status Verified

March 1, 2026

Enrollment Period

2 months

First QC Date

December 28, 2023

Last Update Submit

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

EXPERIMENTAL

patients with dystonia were submitted to a neuropsychological evaluation

Behavioral: experimental groupDiagnostic Test: EEG power in alpha band

control group

EXPERIMENTAL

healthy patients were submitted to a neuropsychological evaluation

Behavioral: control groupDiagnostic Test: EEG power in alpha band

Interventions

control groupBEHAVIORAL

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

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

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

control groupexperimental group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

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

Location

MeSH Terms

Conditions

DystoniaNervous System Diseases

Interventions

Control Groups

Condition Hierarchy (Ancestors)

DyskinesiasNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

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

Locations