N/A
N=9
Chronic Effects of DBS in Parkinson's Disease and Dystonia
Parkinson's Disease · Isolated Dystonia
Bottom Line
View on ClinicalTrials.gov: NCT01934296 ↗Enrolled (actual)
9
Serious AEs
0.0%
Results posted
Apr 2023
Primary outcome: Primary: Number of Patients With Parkinson's Disease With Reliable Cortical and Sub-cortical Brain Signals — 5 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Activa PC+S (Device)
- Age
- Adult, Older Adult · 22+ yrs
- Sex
- All
- Sponsor
- University of California, San Francisco
- Primary completion
- Dec 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With Parkinson's Disease With Reliable Cortical and Sub-cortical Brain Signals |
5 | — |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT01934296). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.