Chronic Effects of DBS in Parkinson's Disease and Dystonia



Status:Active, not recruiting
Conditions:Parkinsons Disease, Neurology, Orthopedic
Therapuetic Areas:Neurology, Orthopedics / Podiatry
Healthy:No
Age Range:22 - 75
Updated:12/12/2018
Start Date:November 2013
End Date:December 2019

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

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.


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.
We found this trial at
1
site
San Francisco, California 94115
?
mi
from
San Francisco, CA
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