DystoniaD-DISTNCT06264063
Study of Behavioral Dysfunctions and Related Neuronal Correlates in Patients With Dystonia
A study testing experimental group and EEG power in alpha band in people with Dystonia and Neurologic Disorder, run by IRCCS Centro Neurolesi Bonino Pulejo at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Dystonia, Neurologic Disorder, NEUROSCIENCE
- What is being tested?
- experimental group and EEG power in alpha band
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteItaly
- Study dates
- 10 Jan 2024to 10 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- > 18 years old;
- Informed consent;
- Montreal cognitive assessment > 21;
Who cannot join
- Patients with cervical dystonia with anterocollis spasm;
- Sensory-motor deficits that can hinder neuropsychological assessment
- Contraindications to performing Magnetic Resonance Imaging
Trial locations and contacts
1 site in 1 country.
About this study
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
- Conditions
- Dystonia, Neurologic Disorder, NEUROSCIENCE
- Being tested
- control group, experimental group, EEG power in alpha band
- Medical subject headings
- Dystonia, Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
control groupBehavioural
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 groupBehavioural
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
EEG power in alpha bandDiagnostic test
partecipants were submitted to registration of electrical activity with EEG to study the EEG power in alpha band
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | patients with dystonia were submitted to a neuropsychological evaluation Receives: Behavioral: experimental group; Diagnostic Test: EEG power in alpha band |
| control group | Experimental | healthy patients were submitted to a neuropsychological evaluation Receives: Behavioral: control group; Diagnostic Test: EEG power in alpha band |
What is being measured
The primary outcome is the main question the study is designed to answer.
montreal cognitive assessment
Study of cognitive functions in dystonic subjects, with particular reference to the mechanisms of memory, attention and executive functions
Measured: 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
Measured: 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
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2024
- Study start10 Jan 2024
- Primary completion10 Mar 2024
- Study completion10 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DystoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS Centro Neurolesi Bonino Pulejo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Caterina Formica, IRCCS Centro Neurolesi Bonino Pulejo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06264063
- Sponsor's protocol ID
- D-DIST
- Acronym
- D-DIST
- Status last verified
- Mar 2026
- First submitted
- 28 Dec 2023
- Last updated
- 31 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Behavioral Dysfunctions and Related Neuronal Correlates in Patients With Dystonia
- ClinicalTrials.gov ID
- NCT06264063
- Acronym / sponsor ID
- D-DIST / D-DIST
- Conditions
- Dystonia, Neurologic Disorder, NEUROSCIENCE
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- IRCCS Centro Neurolesi Bonino PulejoUniversity, hospital or other
- Study start
- 10 Jan 2024 (actual)
- Primary completion
- 10 Mar 2024 (actual)
- Study completion
- 10 Oct 2025 (actual)
- First posted
- 16 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Behavioral: experimental group, Diagnostic Test: EEG power in alpha bandpatients with dystonia were submitted to a neuropsychological evaluation |
| control group | Experimental | Behavioral: control group, Diagnostic Test: EEG power in alpha bandhealthy patients were submitted to a neuropsychological evaluation |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- > 18 years old;
- Informed consent;
- Montreal cognitive assessment > 21;
Key exclusion criteria (3 listed)
- Patients with cervical dystonia with anterocollis spasm;
- Sensory-motor deficits that can hinder neuropsychological assessment
- Contraindications to performing Magnetic Resonance Imaging
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| control groupthe 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 | Behavioural | control group |
| experimental groupthe 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 | Behavioural | experimental group |
| EEG power in alpha bandpartecipants were submitted to registration of electrical activity with EEG to study the EEG power in alpha band | Diagnostic test | control group, experimental group |
Primary outcome
montreal cognitive assessment
Time frame: 1 hour
Study of cognitive functions in dystonic subjects, with particular reference to the mechanisms of memory, attention and executive functions
Beck depression inventory
Time frame: 1 hour
Study of affective functions in dystonic subjects, with particular reference to the mechanisms of mood and evaluating the presence of depressive symptoms
1 secondary outcome
EEG power in alpha band
Time frame: 1 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2026.
Related trials for Dystonia
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Intrathecal Baclofen and Pediatric Dystonia
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Focused Ultrasound Unilateral Pallidotomy for Medication-Refractory Limb Dystonia
Limb Dystonia, Idiopathic Dystonia
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Deep Brain Stimulation Surgery for Movement Disorders
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Deep Brain Stimulation Surgery for Focal Hand Dystonia
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing experimental group and EEG power in alpha band in people with Dystonia and Neurologic Disorder, run by IRCCS Centro Neurolesi Bonino Pulejo at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
montreal cognitive assessment (time frame: 1 hour). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2026.