Clinical trial NCT02304848: Effects of Deep Brain Stimulation (DBS) Frequency on Neural Synchrony
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson's Disease
Keywords: Parkinson's Disease
DBS
Deep Brain Stimulation
Subthalamic Nucleus
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2014-12-02
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Low frequency stimulation versus no stimulation
timeFrame: 3 years
Secondary outcomes:
measure: Low frequency stimulation versus high frequency stimulation
timeFrame: 3 years
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University Medical Center
state: California
Study officials:
affiliation: Stanford University
name: Helen Bronte-Stewart, MD, MSE, FAAN
role: PRINCIPAL_INVESTIGATOR
References:
citation: O'Day J, Syrkin-Nikolau J, Anidi C, Kidzinski L, Delp S, Bronte-Stewart H. The turning and barrier course reveals gait parameters for detecting freezing of gait and measuring the efficacy of deep brain stimulation. PLoS One. 2020 Apr 29;15(4):e0231984. doi: 10.1371/journal.pone.0231984. eCollection 2020.