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Relationship Between Dopaminergic Asymmetric Degeneration and Attentional Resources in Parkinson's Disease. (RTsAsMIRT)

Primary Purpose

Parkinson Disease, Attention Disturbances

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
MIRT
Sponsored by
Ospedale Generale Di Zona Moriggia-Pelascini
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Parkinson Disease

Eligibility Criteria

40 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    RPD PD patients

    LPD PD patients

    Arm Description

    Right-side affected PD patients. Intervention: MIRT

    Left-side affected (LPD) PD patients. Intervention: MIRT

    Outcomes

    Primary Outcome Measures

    Visual Reaction Times (V RTs)
    Visual Reaction Times
    Auditory Reaction Times (A RTs)
    Auditory Reaction Times
    Multiple Choices RTs (MC RTs)
    Multiple Choices RTs

    Secondary Outcome Measures

    Unified Parkinson's Disease Rating Scale (UPDRS)
    Unified Parkinson's Disease Rating Scale
    Timed Up and Go Test (TUG)
    Timed Up and Go Test

    Full Information

    First Posted
    March 19, 2018
    Last Updated
    May 28, 2018
    Sponsor
    Ospedale Generale Di Zona Moriggia-Pelascini
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03476668
    Brief Title
    Relationship Between Dopaminergic Asymmetric Degeneration and Attentional Resources in Parkinson's Disease.
    Acronym
    RTsAsMIRT
    Official Title
    Relationship Between Dopaminergic Asymmetric Degeneration and Attentional Resources in Parkinson's Disease.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    January 1, 2017 (Actual)
    Primary Completion Date
    August 1, 2017 (Actual)
    Study Completion Date
    August 1, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Ospedale Generale Di Zona Moriggia-Pelascini

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief 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).
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Parkinson Disease, Attention Disturbances

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    100 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    RPD PD patients
    Arm Type
    Active Comparator
    Arm Description
    Right-side affected PD patients. Intervention: MIRT
    Arm Title
    LPD PD patients
    Arm Type
    Active Comparator
    Arm Description
    Left-side affected (LPD) PD patients. Intervention: MIRT
    Intervention Type
    Other
    Intervention Name(s)
    MIRT
    Intervention Description
    4-week multidisciplinary intensive rehabilitation treatment
    Primary Outcome Measure Information:
    Title
    Visual Reaction Times (V RTs)
    Description
    Visual Reaction Times
    Time Frame
    4 weeks
    Title
    Auditory Reaction Times (A RTs)
    Description
    Auditory Reaction Times
    Time Frame
    4 weeks
    Title
    Multiple Choices RTs (MC RTs)
    Description
    Multiple Choices RTs
    Time Frame
    4 weeks
    Secondary Outcome Measure Information:
    Title
    Unified Parkinson's Disease Rating Scale (UPDRS)
    Description
    Unified Parkinson's Disease Rating Scale
    Time Frame
    4 weeks
    Title
    Timed Up and Go Test (TUG)
    Description
    Timed Up and Go Test
    Time Frame
    4 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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. Exclusion Criteria: 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Giuseppe Frazzitta, MD
    Organizational Affiliation
    epartment of Parkinson's disease, Movement Disorders and Brain Injury Rehabilitation, "Moriggia-Pelascini" Hospital - Via Pelascini, 3, 22015, Gravedona ed Uniti, Como, Italy
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Relationship Between Dopaminergic Asymmetric Degeneration and Attentional Resources in Parkinson's Disease.

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