Chronic Effects of DBS in Parkinson's Disease and Dystonia (Activa PC+S)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01934296 |
Recruitment Status :
Completed
First Posted : September 4, 2013
Last Update Posted : April 4, 2022
|
- Study Details
- Tabular View
- Results Submitted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Parkinson's Disease Isolated Dystonia | Device: Activa PC+S | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 11 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Basic Science |
Official Title: | Chronic Effects of Deep Brain Stimulation on Cortical Local Field Potentials in Parkinson's Disease and Dystonia |
Study Start Date : | November 2013 |
Actual Primary Completion Date : | December 2021 |
Actual Study Completion Date : | December 2021 |

Arm | Intervention/treatment |
---|---|
Experimental: 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.
|
Device: Activa PC+S
Surgical implantation of Activa PC+S as one component of a therapeutic DBS system implantation |
- Cortical and sub-cortical brain signals using Activa PC+S [ Time Frame: 24 months ]Establish whether it is possible to record a reliable cortical and subcortical brain signal using Activa PC+S.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 22 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01934296
United States, California | |
UCSF Surgical Movement Disorders Center | |
San Francisco, California, United States, 94115 |
Principal Investigator: | Philip Starr, MD | University of California, San Francisco |
Responsible Party: | Philip Starr, Professor, Neurological Surgery, University of California, San Francisco |
ClinicalTrials.gov Identifier: | NCT01934296 |
Other Study ID Numbers: |
Activa PC+S |
First Posted: | September 4, 2013 Key Record Dates |
Last Update Posted: | April 4, 2022 |
Last Verified: | March 2022 |
deep brain stimulation cortical recording neuroprosthesis |
Parkinson Disease Dystonia Dystonic Disorders Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Movement Disorders Synucleinopathies Neurodegenerative Diseases Dyskinesias Neurologic Manifestations |