Isolated Dystonia, Parkinson's Disease
Conditions
Keywords
deep brain stimulation, cortical recording, neuroprosthesis
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.
Interventions
DEVICEActiva PC+S
Surgical implantation of Activa PC+S as one component of a therapeutic DBS system implantation
Sponsors
Medtronic
University of California, San Francisco
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Parkinson's Disease With Reliable Cortical and Sub-cortical Brain Signals | 24 months | To report number of PD patients with reliable cortical and subcortical brain signal recorded using Activa PC+S. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 9 |
| Total | 9 |
Baseline characteristics
| Characteristic | Chronic Brain Recording |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants |
| Age, Continuous | 57.44 years STANDARD_DEVIATION 9.32 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 9 Participants |
| Region of Enrollment United States | 9 Participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 9 |
| other Total, other adverse events | 2 / 9 |
| serious Total, serious adverse events | 0 / 9 |
Outcome results
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.
Time frame: 24 months
Population: 5 patients with Parkinson's disease
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Chronic Brain Recording | Number of Patients With Parkinson's Disease With Reliable Cortical and Sub-cortical Brain Signals | 5 Participants |