Chronic Effects of DBS in Parkinson's Disease and Dystonia

Parkinson's Disease Clinical Trial

— Activa PC+S  

Official title:

Chronic Effects of Deep Brain Stimulation on Cortical Local Field Potentials in Parkinson's Disease and Dystonia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01934296
• Other study ID #: Activa PC+S
• Status: Completed
• Phase: N/A
• Start date: November 2013
• Est. completion date: December 2021

Study information

• Verified date: April 2023
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dystonia
• Dystonic Disorders
• Isolated Dystonia
• Parkinson Disease
• Parkinson's Disease

Intervention

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

Locations

Country	Name	City	State
United States	UCSF Surgical Movement Disorders Center	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	Medtronic

Country where clinical trial is conducted

United States, 

References & 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 Park — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	24 months