Chronic Effects of DBS in Parkinson's Disease and Dystonia | NCT01934296

NCT01934296

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module

Status Module

Name	Class
Medtronic	INDUSTRY

Oversight Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
chronic brain recording	Experimental	This is a one-arm, single-center study of the neurophysiology of human movement disorders with two goals: 1) Assess the feasibility of chronic brain recording using a novel fully implantable pulse generator (Medtronic Activa PC+S), which has the capability of sensing and storing local field potentials (LFPs) recorded from implanted electrodes, in addition to providing therapeutic deep brain stimulation (DBS). 2) Study acute and chronic effects of therapeutic DBS on cortical LFPs. 3) Study feasibility of the use of brain signals as feedback either directly to the patient or for DBS stimulation adjustments.	Device: Activa PC+S

Name	Type	Description	Arm Group Labels	Other Names
Activa PC+S	Device	Surgical implantation of Activa PC+S as one component of a therapeutic DBS system implantation	chronic brain recording

Measure	Description	Time Frame
Number of Patients With Parkinson's Disease With Reliable Cortical and Sub-cortical Brain Signals	To report number of PD patients with reliable cortical and subcortical brain signal recorded using Activa PC+S.	24 months

Eligibility Module

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.

Name	Affiliation	Role
Philip Starr, MD	University of California, San Francisco	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
UCSF Surgical Movement Disorders Center		San Francisco	California	94115	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
28409730	Result	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.

Arm/Group Information

ID	Title	Description
FG000	Chronic Brain Recording	This is a one-arm, single-center study of the neurophysiology of human movement disorders with two goals: 1) Assess the feasibility of chronic brain recording using a novel fully implantable pulse generator (Medtronic Activa PC+S), which has the capability of sensing and storing local field potentials (LFPs) recorded from implanted electrodes, in addition to providing therapeutic deep brain stimulation (DBS). 2) Study acute and chronic effects of therapeutic DBS on cortical LFPs. 3) Study feasibility of the use of brain signals as feedback either directly to the patient or for DBS stimulation adjustments. Activa PC+S: Surgical implantation of Activa PC+S as one component of a therapeutic DBS system implantation

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	Chronic Brain Recording	This is a one-arm, single-center study of the neurophysiology of human movement disorders with two goals: 1) Assess the feasibility of chronic brain recording using a novel fully implantable pulse generator (Medtronic Activa PC+S), which has the capability of sensing and storing local field potentials (LFPs) recorded from implanted electrodes, in addition to providing therapeutic deep brain stimulation (DBS). 2) Study acute and chronic effects of therapeutic DBS on cortical LFPs. 3) Study feasibility of the use of brain signals as feedback either directly to the patient or for DBS stimulation adjustments. Activa PC+S: Surgical implantation of Activa PC+S as one component of a therapeutic DBS system implantation

Units	Counts
Participants	BG000

Baseline Measures

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Categorical			Count of Participants

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Patients With Parkinson's Disease With Reliable Cortical and Sub-cortical Brain Signals

To report number of PD patients with reliable cortical and subcortical brain signal recorded using Activa PC+S.

5 patients with Parkinson's disease

Posted

Count of Participants

Participants

24 months

ID	Title	Description
OG000	Chronic Brain Recording	This is a one-arm, single-center study of the neurophysiology of human movement disorders with two goals: 1) Assess the feasibility of chronic brain recording using a novel fully implantable pulse generator (Medtronic Activa PC+S), which has the capability of sensing and storing local field potentials (LFPs) recorded from implanted electrodes, in addition to providing therapeutic deep brain stimulation (DBS). 2) Study acute and chronic effects of therapeutic DBS on cortical LFPs. 3) Study feasibility of the use of brain signals as feedback either directly to the patient or for DBS stimulation adjustments. Activa PC+S: Surgical implantation of Activa PC+S as one component of a therapeutic DBS system implantation

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Chronic Brain Recording	This is a one-arm, single-center study of the neurophysiology of human movement disorders with two goals: 1) Assess the feasibility of chronic brain recording using a novel fully implantable pulse generator (Medtronic Activa PC+S), which has the capability of sensing and storing local field potentials (LFPs) recorded from implanted electrodes, in addition to providing therapeutic deep brain stimulation (DBS). 2) Study acute and chronic effects of therapeutic DBS on cortical LFPs. 3) Study feasibility of the use of brain signals as feedback either directly to the patient or for DBS stimulation adjustments. Activa PC+S: Surgical implantation of Activa PC+S as one component of a therapeutic DBS system implantation

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Cerebrospinal Fluid (CSF) collected under scalp	Surgical and medical procedures		Non-systematic Assessment	One patient had a transient sterile fluid collection, consistent with CSF, under the frontal scalp postoperatively that appeared in the morning after sleep and disappeared in the upright posture.

ID	Term
D020734	Parkinsonian Disorders
D001480	Basal Ganglia Diseases
D001927	Brain Diseases
D002493	Central Nervous System Diseases