Chronic Effects of DBS in Parkinson's Disease and Dystonia (Activa PC+S)

• ClinicalTrials.gov Identifier: NCT01934296
• Recruitment Status: Active, not recruiting
• First Posted: September 4, 2013
• Last Update Posted: January 15, 2021
• Sponsor: University of California, San Francisco
• Collaborator: Medtronic
• Information provided by (Responsible Party): Philip Starr, University of California, San Francisco

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Parkinson's Disease; Isolated Dystonia	Device: Activa PC+S	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 11 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Chronic Effects of Deep Brain Stimulation on Cortical Local Field Potentials in Parkinson's Disease and Dystonia
• Study Start Date: November 2013
• Estimated Primary Completion Date: December 2021
• Estimated Study Completion Date: December 2021

Arms and Interventions

Arm

Intervention/treatment

Experimental: 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.

Device: Activa PC+S; Surgical implantation of Activa PC+S as one component of a therapeutic DBS system implantation

Outcome Measures

Primary Outcome Measures :

1. Cortical and sub-cortical brain signals using Activa PC+S [ Time Frame: 24 months ]
   Establish whether it is possible to record a reliable cortical and subcortical brain signal using Activa PC+S.

Eligibility Criteria

• Ages Eligible for Study: 22 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United States, California

UCSF Surgical Movement Disorders Center

San Francisco, California, United States, 94115

Sponsors and Collaborators

University of California, San Francisco

Medtronic

Investigators

• Principal Investigator: Philip Starr, MD; University of California, San Francisco

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Philip Starr, Professor, Neurological Surgery, University of California, San Francisco
• ClinicalTrials.gov Identifier: NCT01934296
• Other Study ID Numbers: Activa PC+S
• First Posted: September 4, 2013
• Last Update Posted: January 15, 2021
• Last Verified: January 2021

Keywords provided by Philip Starr, University of California, San Francisco:

deep brain stimulation; cortical recording; neuroprosthesis

Additional relevant MeSH terms:

Parkinson Disease; Dystonia; Dystonic Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Dyskinesias; Neurologic Manifestations