An interventional study of Activa PC+S in Parkinson's Disease and Isolated Dystonia, sponsored by University of California, San Francisco. Completed at 1 site in United States. Open to participants aged 22 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-04-24.
Sponsored by University of California, San Francisco · Not applicable, Interventional, and Basic science
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.
4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.
This study's enrollment of 9 is below the median of 40 across 3,294 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →University of California, San Francisco is the lead sponsor of 2,132 studies on the registry; 375 are open to participants now.
Of its 262 completed or terminated interventional studies of FDA-regulated products, 196 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria(both groups):
Inclusion criteria (Isolated dystonia):
Inclusion criteria (PD):
Exclusion Criteria (both groups):
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
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.
Time frame: 24 months
| Milestone | Chronic Brain Recording |
|---|---|
| Started | 9 |
| Completed | 9 |
| Not completed | 0 |
To report number of PD patients with reliable cortical and subcortical brain signal recorded using Activa PC+S.
| Participants | Chronic Brain Recording |
|---|---|
| Number of Patients With Parkinson's Disease With Reliable Cortical and Sub-cortical Brain Signals | 5 |
Collected over 2 years for each patient. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Chronic Brain Recording | 0/9 (0%) | 0/9 (0%) | 2/9 (22.2%) |
| Event | Chronic Brain Recording |
|---|---|
| Cerebrospinal Fluid (CSF) collected under scalpSurgical and medical procedures | 1/9 |
| Fatigue after surgerySurgical and medical procedures | 1/9 |
| Age, Categorical(Participants) | Chronic Brain Recording |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 9 |
| >=65 years | 0 |
| Age, Continuous(years) | Chronic Brain Recording |
|---|---|
| Mean | 57.44 ± 9.32 |
| Sex: Female, Male(Participants) | Chronic Brain Recording |
|---|---|
| Female | 3 |
| Male | 6 |
| Race (NIH/OMB)(Participants) | Chronic Brain Recording |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 9 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(Participants) | Chronic Brain Recording |
|---|---|
| United States | 9 |
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This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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University of California, San Francisco