Chronic Effects of DBS in Parkinson's Disease and Dystonia

NCT01934296 | Completed Results DMC

• 1 other identifier: Activa PC+S
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson's Disease; Isolated Dystonia

Keywords

deep brain stimulation; cortical recording; neuroprosthesis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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

Interventions

Activa PC+S DEVICE

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

chronic brain recording

Eligibility Criteria

• Age: 22 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Francisco: lead
• Medtronic: collaborator

Study Sites (1)

UCSF Surgical Movement Disorders Center

San Francisco, California, 94115, United States

Location

Related Publications (1)

• 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.

  PMID: 28409730 RESULT

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Results Point of Contact

• Title: Dr. Sarah Wang, Director of Clinical Research
• Organization: University of California San Francisco

Sarah.Wang@ucsf.edu

416-353-7885

Study Officials

• Philip Starr, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Neurological Surgery

Study Record Dates

• First Submitted: August 29, 2013
• First Posted: September 4, 2013
• Study Start: November 1, 2013
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: April 24, 2023
• Results First Posted: April 24, 2023

Record last verified: 2023-04

Locations

US (1)