NCT02278406

Brief Summary

The purpose of this study is to determine if deep brain stimulation can change brain oxygen levels in people with Parkinson's Disease. Measurements will be taken using a non-invasive device while subjects are both on and off their medications, and while their stimulator is in the on and off setting.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2014

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

October 28, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 30, 2014

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

May 8, 2017

Status Verified

May 1, 2017

Enrollment Period

11 months

First QC Date

October 28, 2014

Last Update Submit

May 3, 2017

Conditions

Parkinson's Disease

Keywords

Parkinson's DiseaseDeep brain stimulatordbs

Outcome Measures

Primary Outcomes (1)

  • Brain oxygen levels

    1 day

Study Arms (1)

Parkinson's patients with DBS

EXPERIMENTAL

Patients with Parkinson's Disease who are at least 3-months post subthalamic deep brain stimulator surgery

Other: Deep brain stimulator

Interventions

Deep brain stimulatorOTHER

We will measure brain oxygen levels with a non-invasive near infrared spectroscopy device.

Parkinson's patients with DBS

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18-75
  • Diagnosis of Idiopathic Parkinson's disease made by a movement disorders neurologist.
  • At least 3 months status-post bilateral subthalamic deep brain stimulation surgery
  • Positive response to STN DBS as evidenced by \>20% improvement in UPDRS-III score after surgery as determined by a movement disorders neurologist.
  • Cognitively intact as demonstrated with a MOCA \> 24.
  • Signed informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

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

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 of Neurosurgery

Study Record Dates

First Submitted

October 28, 2014

First Posted

October 30, 2014

Study Start

October 1, 2014

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

May 8, 2017

Record last verified: 2017-05

Locations

US(1)