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

Sponsor
Ospedale Generale Di Zona Moriggia-Pelascini (Other)
Overall Status
Completed
CT.gov ID
NCT03476668
Collaborator
(none)
100
Enrollment
2
Arms
7
Actual Duration (Months)

Study Details

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).

Condition or Disease Intervention/Treatment Phase
  • Other: MIRT
 N/A

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

Study Type:
Interventional
Actual Enrollment :
100 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Relationship Between Dopaminergic Asymmetric Degeneration and Attentional Resources in Parkinson's Disease.
Actual Study Start Date :
Jan 1, 2017
Actual Primary Completion Date :
Aug 1, 2017
Actual Study Completion Date :
Aug 1, 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Visual Reaction Times (V RTs) [4 weeks]

    Visual Reaction Times

  2. Auditory Reaction Times (A RTs) [4 weeks]

    Auditory Reaction Times

  3. Multiple Choices RTs (MC RTs) [4 weeks]

    Multiple Choices RTs

Secondary Outcome Measures

  1. Unified Parkinson's Disease Rating Scale (UPDRS) [4 weeks]

    Unified Parkinson's Disease Rating Scale

  2. Timed Up and Go Test (TUG) [4 weeks]

    Timed Up and Go Test

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ospedale Generale Di Zona Moriggia-Pelascini
ClinicalTrials.gov Identifier:
NCT03476668
Other Study ID Numbers:
  • MIRT-RTs-Laterality
First Posted:
Mar 26, 2018
Last Update Posted:
May 30, 2018
Last Verified:
May 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Parkinson Disease

Study Results

No Results Posted as of May 30, 2018