Parkinson DiseaseRTsAsMIRTNCT03476668
Relationship Between Dopaminergic Asymmetric Degeneration and Attentional Resources in Parkinson's Disease.
A study testing MIRT in people with Parkinson Disease and Attention Disturbances, run by Ospedale Generale Di Zona Moriggia-Pelascini.
Trial summary
The researchers aimed to investigate the relationship between the asymmetric dopaminergic degeneration and the attentional resources in a group of patients with Parkinson's disease (PD). Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Parkinson Disease, Attention Disturbances
- What is being tested?
- MIRT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2017to 1 Aug 2017
- 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 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stage 2.5-3 according to the Hoehn and Yahr scale (H\&Y);
- Stable pharmacological treatment for the last 6 weeks before the enrolment and during the hospitalization;
- Mini Mental State Examination (MMSE) ≥ 24;
- No evidences of dysexecutive syndrome.
Who cannot join
- Any focal brain lesion detected in brain imaging studies (CT or MRI) performed in the previous 12 months;
- Drug-induced dyskinesias;
- Disturbing resting and/or action tremor, corresponding to scores 2-4 in the specific items of UPDRS III;
- Behavioral disturbances (evaluated with Neuropsychiatric Inventory);
- Visual and auditory dysfunctions according to the general clinical evaluation and medical history;
- Equivocal report about the side of disease onset or bilateral motor involvement.
About this study
The researchers aimed to investigate the relationship between the asymmetric dopaminergic degeneration and the attentional resources in a group of patients with Parkinson's disease (PD).
Read the detailed description
To bypass the impaired habitual motor-behavioural control, Parkinson's disease (PD) patients may exploit the network of goal-directed mode of action. The frontostriatal connections underline this functioning, that is based on attention. Since the cognitive processes are related with dopamine, the asymmetrical degeneration of the dopaminergic system affects differently the right side affected (RPD) and the left side affected (LPD) PD patients.
The aim of the study was to investigate the relationship between the asymmetric dopaminergic degeneration and the attentional resources in a group of patients with PD.
- Conditions
- Parkinson Disease, Attention Disturbances
- Being tested
- MIRT
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MIRTOther
4-week multidisciplinary intensive rehabilitation treatment
| Study group | Role | What they receive |
|---|---|---|
| RPD PD patients | Active comparator | Right-side affected PD patients. Intervention: MIRT Receives: Other: MIRT |
| LPD PD patients | Active comparator | Left-side affected (LPD) PD patients. Intervention: MIRT Receives: Other: MIRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Reaction Times (V RTs)
Visual Reaction Times
Measured: 4 weeks
Auditory Reaction Times (A RTs)
Auditory Reaction Times
Measured: 4 weeks
Multiple Choices RTs (MC RTs)
Multiple Choices RTs
Measured: 4 weeks
Secondary outcomes (2)
Unified Parkinson's Disease Rating Scale (UPDRS)
Unified Parkinson's Disease Rating Scale
Measured: 4 weeks
Timed Up and Go Test (TUG)
Timed Up and Go Test
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2018
- Study start1 Jan 2017
- Primary completion1 Aug 2017
- Study completion1 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ospedale Generale Di Zona Moriggia-Pelascini
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Giuseppe Frazzitta, MD, Principal investigator, epartment of Parkinson's disease, Movement Disorders and Brain Injury Rehabilitation, "Moriggia-Pelascini" Hospital - Via Pelascini, 3, 22015, Gravedona ed Uniti, Como, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03476668
- Sponsor's protocol ID
- MIRT-RTs-Laterality
- Acronym
- RTsAsMIRT
- Status last verified
- May 2018
- First submitted
- 19 Mar 2018
- Last updated
- 30 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Dopaminergic Asymmetric Degeneration and Attentional Resources in Parkinson's Disease.
- ClinicalTrials.gov ID
- NCT03476668
- Acronym / sponsor ID
- RTsAsMIRT / MIRT-RTs-Laterality
- Conditions
- Parkinson Disease, Attention Disturbances
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Ospedale Generale Di Zona Moriggia-PelasciniUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Aug 2017 (actual)
- Study completion
- 1 Aug 2017 (actual)
- First posted
- 26 Mar 2018 (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.
The researchers aimed to investigate the relationship between the asymmetric dopaminergic degeneration and the attentional resources in a group of patients with Parkinson's disease (PD).
Detailed description
To bypass the impaired habitual motor-behavioural control, Parkinson's disease (PD) patients may exploit the network of goal-directed mode of action. The frontostriatal connections underline this functioning, that is based on attention. Since the cognitive processes are related with dopamine, the asymmetrical degeneration of the dopaminergic system affects differently the right side affected (RPD) and the left side affected (LPD) PD patients.
The aim of the study was to investigate the relationship between the asymmetric dopaminergic degeneration and the attentional resources in a group of patients with PD.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RPD PD patients | Active comparator | Other: MIRTRight-side affected PD patients. Intervention: MIRT |
| LPD PD patients | Active comparator | Other: MIRTLeft-side affected (LPD) PD patients. Intervention: MIRT |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Stage 2.5-3 according to the Hoehn and Yahr scale (H\&Y);
- Stable pharmacological treatment for the last 6 weeks before the enrolment and during the hospitalization;
- Mini Mental State Examination (MMSE) ≥ 24;
- No evidences of dysexecutive syndrome.
Key exclusion criteria (6 listed)
- Any focal brain lesion detected in brain imaging studies (CT or MRI) performed in the previous 12 months;
- Drug-induced dyskinesias;
- Disturbing resting and/or action tremor, corresponding to scores 2-4 in the specific items of UPDRS III;
- Behavioral disturbances (evaluated with Neuropsychiatric Inventory);
- Visual and auditory dysfunctions according to the general clinical evaluation and medical history;
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 |
|---|---|---|
| MIRT4-week multidisciplinary intensive rehabilitation treatment | Other | LPD PD patients, RPD PD patients |
Primary outcome
Visual Reaction Times (V RTs)
Time frame: 4 weeks
Visual Reaction Times
Auditory Reaction Times (A RTs)
Time frame: 4 weeks
Auditory Reaction Times
Multiple Choices RTs (MC RTs)
Time frame: 4 weeks
Multiple Choices RTs
2 secondary outcomes
Unified Parkinson's Disease Rating Scale (UPDRS)
Time frame: 4 weeks
Timed Up and Go Test (TUG)
Time frame: 4 weeks
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 30 May 2018.
- Individual participant dataSharing planned: No
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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.
Giuseppe Frazzitta, MD principal investigator
epartment of Parkinson's disease, Movement Disorders and Brain Injury Rehabilitation, "Moriggia-Pelascini" Hospital - Via Pelascini, 3, 22015, Gravedona ed Uniti, Como, Italy
Questions about this trial
What is this clinical trial studying?
A study testing MIRT in people with Parkinson Disease and Attention Disturbances, run by Ospedale Generale Di Zona Moriggia-Pelascini.
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 4 inclusion and 6 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 30 May 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Visual Reaction Times (V RTs) (time frame: 4 weeks). The study lists 3 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 30 May 2018.