NCT03476668

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).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P75+ for not_applicable parkinson-disease

Timeline
Completed

Started Jan 2017

Shorter than P25 for not_applicable parkinson-disease

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 19, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 26, 2018

Completed
Last Updated

May 30, 2018

Status Verified

May 1, 2018

Enrollment Period

7 months

First QC Date

March 19, 2018

Last Update Submit

May 28, 2018

Conditions

Outcome Measures

Primary Outcomes (3)

  • Visual Reaction Times (V RTs)

    Visual Reaction Times

    4 weeks

  • Auditory Reaction Times (A RTs)

    Auditory Reaction Times

    4 weeks

  • Multiple Choices RTs (MC RTs)

    Multiple Choices RTs

    4 weeks

Secondary Outcomes (2)

  • Unified Parkinson's Disease Rating Scale (UPDRS)

    4 weeks

  • Timed Up and Go Test (TUG)

    4 weeks

Study Arms (2)

RPD PD patients

ACTIVE COMPARATOR

Right-side affected PD patients. Intervention: MIRT

Other: MIRT

LPD PD patients

ACTIVE COMPARATOR

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

Other: MIRT

Interventions

MIRTOTHER

4-week multidisciplinary intensive rehabilitation treatment

LPD PD patientsRPD PD patients

Eligibility Criteria

Age40 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 19, 2018

First Posted

March 26, 2018

Study Start

January 1, 2017

Primary Completion

August 1, 2017

Study Completion

August 1, 2017

Last Updated

May 30, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share