Clinical trial NCT01934296: Chronic Effects of DBS in Parkinson's Disease and Dystonia
Official title: Chronic Effects of Deep Brain Stimulation on Cortical Local Field Potentials in Parkinson's Disease and Dystonia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson's Disease
Isolated Dystonia
Keywords: deep brain stimulation
cortical recording
neuroprosthesis
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Medtronic
First posted: 2013-09-04
Enrollment: 9
Sex: ALL
Minimum age (years): 22
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to use an investigational device to record brain activity for 12-24 months following surgical implantation of deep brain stimulation (DBS) systems. The goal of the study is better understanding of brain activity in movement disorders and how they relate to DBS, not to bring new devices to market.


Eligibility criteria: Inclusion Criteria(both groups):

* Ability to give informed consent for the study
* Movement disorder symptoms that are sufficiently severe, in spite of best medical therapy, to warrant surgical implantation of deep brain stimulators according to standard clinical criteria

Inclusion criteria (Isolated dystonia):

* Age 22-75
* Isolated dystonia that is generalized or segmental, that must affect one or - Stable doses of anti-dystonia medications (such as Artane, Baclofen, or Clonopin) for at least 30 days prior to baseline assessment
* For patients with craniofacial involvement, prior treatment with botulinum toxin with failure to adequately control dystonia symptoms.

Inclusion criteria (PD):

* Age 30-75
* Bilateral disease (Hoehn and Yahr stage 2 or greater)
* Has been treated with levodopa/carbidopa, and with a dopamine agonist, at the maximal tolerated doses as determined by a movement disorders neurologist
* Stable doses of antiParkinsonian medications for at least 30 days prior to their baseline assessment
* Significant disability in the setting of optimal medical management by a movement disorders neurologist. Disability may be due to tremor that is unresponsive to medications, or to motor fluctuations
* UPDRS-III score off medication between 20 and 60
* Improvement of at least 30% in the baseline UPDRS-III on medication score, compared to the baseline off-medication score.

Exclusion Criteria (both groups):

* Pregnancy or breast feeding
* MRI showing cortical atrophy out of proportion to age
* MRI showing focal brain lesions that could indicate a non-idiopathic movement disorder,
* Major comorbidity increasing the risk of surgery (prior stroke, severe hypertension, severe diabetes, or need for chronic anticoagulation other than aspirin)
* Inability to comply with study follow-up visits
* Any prior intracranial surgery
* Mood depression with a Beck depression inventory score of \> 17 on baseline screening
* Significant cognitive impairment (MoCA\<25).
* History of seizures
* Immunocompromised
* Has an active infection
* Requires diathermy, electroconvulsive therapy (ECT) or transcranial magnetic - Has an implanted electronic device such as a neurostimulator, cardiac pacemaker or medication pump.

Primary outcomes:
measure: Number of Patients With Parkinson's Disease With Reliable Cortical and Sub-cortical Brain Signals
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF Surgical Movement Disorders Center
state: California
Study officials:
affiliation: University of California, San Francisco
name: Philip Starr, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Swann NC, de Hemptinne C, Miocinovic S, Qasim S, Ostrem JL, Galifianakis NB, Luciano MS, Wang SS, Ziman N, Taylor R, Starr PA. Chronic multisite brain recordings from a totally implantable bidirectional neural interface: experience in 5 patients with Parkinson's disease. J Neurosurg. 2018 Feb;128(2):605-616. doi: 10.3171/2016.11.JNS161162. Epub 2017 Apr 14.