Relationship Between Dopaminergic Asymmetric Degeneration and Attentional Resources in Parkinson's Disease.
RTsAsMIRT
1 other identifier
interventional
100
0 countries
N/A
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable parkinson-disease
Started Jan 2017
Shorter than P25 for not_applicable parkinson-disease
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
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2017
CompletedFirst Submitted
Initial submission to the registry
March 19, 2018
CompletedFirst Posted
Study publicly available on registry
March 26, 2018
CompletedMay 30, 2018
May 1, 2018
7 months
March 19, 2018
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 COMPARATORRight-side affected PD patients. Intervention: MIRT
LPD PD patients
ACTIVE COMPARATORLeft-side affected (LPD) PD patients. Intervention: MIRT
Interventions
Eligibility Criteria
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
Condition Hierarchy (Ancestors)
Study Officials
- 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 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