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Completed

NCT Number: NCT01934296

Chronic Effects of DBS 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.

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Key information

Age range

22 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCSF Surgical Movement Disorders Center

San Francisco, California, 94115, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Activa PC+S

Device

Surgical implantation of Activa PC+S as one component of a therapeutic DBS system implantation

Primary outcomes

  1. Number of Patients With Parkinson's Disease With Reliable Cortical and Sub-cortical Brain Signals

    Time frame: 24 months

    To report number of PD patients with reliable cortical and subcortical brain signal recorded using Activa PC+S.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • Medtronic

Registry information

Official study title

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

Acronym: Activa PC+S

Important dates

Study start
2013
Primary completion
2021
Study completion
2021
First posted
Sep 4, 2013
Registry last updated
Apr 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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