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Non-invasive Measurement of Brain Oxygen Levels in People With Subthalamic Deep Brain Stimulators

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02278406
Recruitment Status : Completed
First Posted : October 30, 2014
Last Update Posted : May 8, 2017
Sponsor:
Information provided by (Responsible Party):
Ron Alterman, Beth Israel Deaconess Medical Center

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.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Other: Deep brain stimulator Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Employing Near Infrared Spectroscopy to Non-invasively Assess Changes in Cerebral Perfusion in Response to Subthalamic Deep Brain Stimulation
Study Start Date : October 2014
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Parkinson's patients with DBS
Patients with Parkinson's Disease who are at least 3-months post subthalamic deep brain stimulator surgery
Other: Deep brain stimulator
We will measure brain oxygen levels with a non-invasive near infrared spectroscopy device.




Primary Outcome Measures :
  1. Brain oxygen levels [ Time Frame: 1 day ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Failure to meet all of the inclusion criteria.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02278406


Locations
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United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center

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Responsible Party: Ron Alterman, Professor of Neurosurgery, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT02278406    
Other Study ID Numbers: 2013P000117
First Posted: October 30, 2014    Key Record Dates
Last Update Posted: May 8, 2017
Last Verified: May 2017
Keywords provided by Ron Alterman, Beth Israel Deaconess Medical Center:
Parkinson's Disease
Deep brain stimulator
dbs
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases