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Effects of Deep Brain Stimulation (DBS) Frequency on Neural Synchrony (DBS)

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ClinicalTrials.gov Identifier: NCT02304848
Recruitment Status : Completed
First Posted : December 2, 2014
Last Update Posted : March 11, 2019
Sponsor:
Information provided by (Responsible Party):
Helen M. Bronte-Stewart, Stanford University

Study Description
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Brief Summary:
The purpose of this study is to evaluate the effects of low frequency deep brain stimulation on subthalamic nucleus neural synchrony. Low frequency stimulation does not improve the cardinal motor signs of Parkinson's disease, and may be beneficial only for gait and speech. This study will provide insight into what the effects of low frequency stimulation are on neural synchrony.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Other: DBS (Deep Brain Stimulation) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : October 2012
Actual Primary Completion Date : November 28, 2017
Actual Study Completion Date : November 28, 2017

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Arms and Interventions
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Arm Intervention/treatment
Experimental: DBS (Deep Brain Stimulation)
DBS ( Deep Brain Stimulation) ( both high and low frequency deep brain stimulation will be applied to the subthalamic nucleus)
 Other: DBS (Deep Brain Stimulation)
Applying low frequency and high frequency deep brain stimulation to subthalamic nucleus.


Outcome Measures
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Primary Outcome Measures :
  1. Low frequency stimulation versus no stimulation [ Time Frame: 3 years ]
    The changes in neuronal oscillations, measured in power (dB/Hz) and frequency (Hz), that are significantly different between periods of low frequency stimulation and periods of no stimulation - during rest - in people with Parkinson's disease off medications.


Secondary Outcome Measures :
  1. Low frequency stimulation versus high frequency stimulation [ Time Frame: 3 years ]
    To determine if the effects of low frequency stimulation are due to using a lower total power delivered than normal therapeutic high frequency stimulation.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • A diagnosis of idiopathic Parkinson's disease, with bilateral symptoms at Hoehn and Yahr Stage greater than or equal to II.
  • Documented improvement in motor signs on versus off dopaminergic medication, with a change in the Unified Parkinson's Disease Rating Scale motor (UPDRS III) score of >= 30% off to on medication.
  • The presence of complications of medication such as wearing off signs, fluctuating responses and/or dyskinesias, and/or medication refractory tremor, and/or impairment in the quality of life on or off medication due to these factors.
  • Subjects should be on stable doses of medications, which should remain unchanged until the DBS system is activated. After the DBS system is optimized (during which time the overall medication dose may be reduced to avoid discomfort and complications such as dyskinesias) the medication dose should remain unchanged, if possible, for the duration of the study.
  • Treatment with carbidopa/levodopa, and with a dopamine agonist at the maximal tolerated doses as determined by a movement disorders neurologist.
  • Age > 18

Exclusion Criteria:

  • Subjects with significant cognitive impairment and/or dementia as determined by a standardized neuropsychological battery.
  • Subjects with clinically active depression, defined according to the Diagnostic and Statistical manual of Mental Disorders, Fourth Edition (DSM-IV) criteria and as scored on a validated depression assessment scale.
  • Subjects with very advanced Parkinson's disease, Hoehn and Yahr stage 5 on medication (non-ambulatory).
  • Age > 80.
  • Subjects with an implanted electronic device such as a neurostimulator, cardiac pacemaker/defibrillator or medication pump.
  • Subjects, who are pregnant, are capable of becoming pregnant, or who are breast feeding.
  • Patients with cortical atrophy out of proportion to age or focal brain lesions that could indicate a non-idiopathic movement disorder as determined by MRI
  • Subjects having a major comorbidity increasing the risk of surgery (prior stroke, severe hypertension, severe diabetes, or need for chronic anticoagulation other than aspirin).
  • Subjects having any prior intracranial surgery.
  • Subjects with a history of seizures.
  • Subjects, who are immunocompromised.
  • Subjects with an active infection.
  • Subjects, who require diathermy, electroconvulsive therapy (ECT), or transcranial magnetic stimulation (TMS) to treat a chronic condition.
  • Subjects, who have an inability to comply with study follow-up visits.
  • Subjects, who are unable to understand or sign the informed consent
Contacts and Locations
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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): NCT02304848


Locations
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United States, California
Stanford University Medical Center
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Helen Bronte-Stewart, MD, MSE, FAAN Stanford University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Helen M. Bronte-Stewart, Dr, Stanford University
ClinicalTrials.gov Identifier: NCT02304848    
Other Study ID Numbers: 60130
First Posted: December 2, 2014    Key Record Dates
Last Update Posted: March 11, 2019
Last Verified: March 2019
Keywords provided by Helen M. Bronte-Stewart, Stanford University:
Parkinson's Disease
DBS
Deep Brain Stimulation
Subthalamic Nucleus
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
Synucleinopathies
Neurodegenerative Diseases