NCT01845883

Brief Summary

In this proposal the investigators have three Specific Aims using human patient populations as model systems; 1) identify a role for the Basal Ganglia (BG) in perceptual decision making; 2) determine whether the Basal Ganglia contribute to decision making under conditions of visual uncertainty; 3) determine whether the cerebellum plays a role in perceptual decision-making under conditions of visual uncertainty. The investigators designed experiments using healthy humans and humans with diseases known to affect the Basal Ganglia and the cerebellum, Parkinson's Disease, dystonia and non-dystonic cerebellar damage. With this approach the investigators will test the following hypotheses: 1) Patients with Parkinson's Disease and dystonia will have more difficulty than healthy controls making perceptual decisions when faced with sensory uncertainty; when sensory information is certain, patients will show improved decision-making but will still be impaired relative to healthy humans. Hypothesis 2: If ambiguous sensory information is aided by prior information, patients with Parkinson's Disease and dystonia will be unable to use the prior (bias/memory) information to inform their decisions. Hypothesis 3: Deep Brain Stimulation (DBS) of Basal Ganglia structures will improve the ability of patients to use prior information to inform their decisions when faced with sensory uncertainty. Hypothesis 4: Both cholinergic and dopaminergic medical therapies will improve the ability of patients to use prior information to inform their decisions. Hypothesis 5: Patients with non-dystonic cerebellar damage will be similar to healthy controls in performance of a perceptual decision making task in conditions of visual uncertainty. The overarching framework of this application is that the same mechanisms (D1 striatal synaptic plasticity) that operate in reward learning play a role in learning and using stimulus priors in a perceptual decision-making task when faced with uncertainty. Because Parkinson's Disease and dystonia share deficits in striatal circuitry, the patient deficits on this task will be similar. Because non-dystonic cerebellar patients do not have dysfunction of striatal circuits, they will show no deficits in the ability to use stimulus priors to guide choices in uncertain conditions. In the event these patients do show deficits, this is will provide evidence for an unexplored role for the cerebellum in perceptual decision-making.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

April 1, 2013

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

April 23, 2013

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 3, 2013

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

December 18, 2015

Status Verified

December 1, 2015

Enrollment Period

2.7 years

First QC Date

April 23, 2013

Last Update Submit

December 17, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • Choice performance - % correct responses out of total number of trials

    data from each subject will be assessed at the end of each session to monitor and measure outcome measures.

    at the end of each testing session - 2 hours

Secondary Outcomes (1)

  • Reaction Time to make a choice - measured in milliseconds

    at the end of each testing session - 2 hours

Study Arms (1)

Deep Brain Stimulator

OTHER

Some of our subjects that participate to the study have Deep Brain Stimulation implanted. They will perform the behavioral task twice, with the stimulation ON or OFF.

Procedure: Deep Brain Stimulation (DBS)

Interventions

Patients with DBS will participate to the study both when the stimulation is off and on.

Deep Brain Stimulator

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Group 1 - Age and Sex matched healthy controls:
  • Age 18-80 Years
  • Group 2 - Patients with Parkinson's Disease - No DBS:
  • "on meds" and "off meds" (tested in separate sessions) - total of 2 sessions
  • Age 45-80 Years
  • Unified PD rating scale (UPDRS)
  • Mini mental health Status (MMHS)
  • Group 3 - Patients with Parkinson's Disease already consented for DBS (STN):
  • Age 45-80 Years
  • Unified PD rating scale (UPDRS)
  • Mini mental health Status (MMHS)
  • Group 4 - Patients with Parkinson's Disease already consented for DBS (GPi):
  • Age 45-80 Years
  • Unified PD rating scale (UPDRS)
  • Mini mental health Status (MMHS)
  • +20 more criteria

You may not qualify if:

  • Visual impairment or ocular motility disorder Inability to sit for the 30 minute task plus 20-30 minute instruction time, setup, and wait time.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Neuroscience Research Building

Los Angeles, California, 90095, United States

RECRUITING

MeSH Terms

Conditions

Parkinson DiseaseDystoniaAtaxia

Interventions

Deep Brain Stimulation

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesDyskinesiasNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsSurgical Procedures, Operative

Study Officials

  • Michele Basso, PhD

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alessandra Perugini, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 23, 2013

First Posted

May 3, 2013

Study Start

April 1, 2013

Primary Completion

December 1, 2015

Study Completion

December 1, 2016

Last Updated

December 18, 2015

Record last verified: 2015-12

Locations