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

May 28, 2018 updated by: Ospedale Generale Di Zona Moriggia-Pelascini
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: RPD PD patients
Right-side affected PD patients. Intervention: MIRT
Other: MIRT
4-week multidisciplinary intensive rehabilitation treatment
Active Comparator: LPD PD patients
Left-side affected (LPD) PD patients. Intervention: MIRT
Other: MIRT
4-week multidisciplinary intensive rehabilitation treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Reaction Times (V RTs)
Time Frame: 4 weeks
Visual Reaction Times
4 weeks
Auditory Reaction Times (A RTs)
Time Frame: 4 weeks
Auditory Reaction Times
4 weeks
Multiple Choices RTs (MC RTs)
Time Frame: 4 weeks
Multiple Choices RTs
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Unified Parkinson's Disease Rating Scale (UPDRS)
Time Frame: 4 weeks
Unified Parkinson's Disease Rating Scale
4 weeks
Timed Up and Go Test (TUG)
Time Frame: 4 weeks
Timed Up and Go Test
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ospedale Generale Di Zona Moriggia-Pelascini

Investigators

  • Principal Investigator: Giuseppe Frazzitta, MD, epartment of Parkinson's disease, Movement Disorders and Brain Injury Rehabilitation, "Moriggia-Pelascini" Hospital - Via Pelascini, 3, 22015, Gravedona ed Uniti, Como, Italy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Actual)

August 1, 2017

Study Completion (Actual)

August 1, 2017

Study Registration Dates

First Submitted

March 19, 2018

First Submitted That Met QC Criteria

March 19, 2018

First Posted (Actual)

March 26, 2018

Study Record Updates

Last Update Posted (Actual)

May 30, 2018

Last Update Submitted That Met QC Criteria

May 28, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MIRT-RTs-Laterality

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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