Recruiting

Movement Disorders

Sponsor:

Colorado Neurological Institute

Code:

NCT02115802

Conditions

Parkinson's Disease

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

Interventions

Activa PC+S

Study Details

Brief summary:

The purpose of this study is to record electrical brain activity during DBS surgery and after DBS surgery using the Medtronic Activa PC+S deep brain stimulation (DBS) system, a modified DBS pulse generator. The goal of the study is to investigate if the electrical brain activity can help customize DBS therapy.

Conditions

Parkinson's Disease

Study ID

NCT02115802

Start date

May, 2014

Status verified date

Feb, 2016

Completion date

Dec, 2017

Anticipated

Primary completion date

Dec, 2017

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Potential participants must be undergoing DBS lead placement for Parkinson's Disease that requires them to be awake during microelectrode recording.
  • Potential participants have been treated with levodopa/carbidopa, and with a dopamine agonist, at the maximal tolerated doses as determined by a movement disorders neurologist.
  • Potential participants must have a Hoehn and Yahr stage >= 2 in the medications OFF state.
  • Potential participants must have documented improvement in motor signs on versus off dopaminergic medication, with a change in the Unified Parkinson's Disease Rating Scale motor (UPDRS III) score of >= 30% off to on medication. Patients with tremor predominant form of PD, quantified as a UPDRS tremor score in any one limb greater than or equal to 3 and UPDRS sum of axial score (speech, posture, gait, balance) less than or equal to 5, who do not reach the 30% threshold, may be included.
  • Potential participants must have evidence of complications of medication, e.g., wearing off signs, fluctuating responses and/or dyskinesias, and/or medication refractory tremor, and/or impairment in the quality of life on or off medication.
  • Potential participants must have the ability to understand instructions in English.
  • Potential participants are males or females between the ages of 21 and 75.

Exclusion Criteria:

  • Individuals who are pregnant, breastfeeding, or are capable of becoming pregnant and not using an acceptable method of birth control. Acceptable methods of birth control include hormonal contraceptives, intrauterine device, abstinence or spermicide and barrier.
  • Individuals who have magnetic resonance imaging (MRI) scans demonstrating cortical atrophy out of proportion to age.
  • Individuals who have MRI scans showing focal brain lesions that could indicate a nonidiopathic movement disorder.
  • Individuals who have major comorbidity increasing the risk of surgery such as prior stroke, severe hypertension, severe diabetes, or need for chronic anticoagulation other than aspirin.
  • Individuals who have had any prior intracranial surgery.
  • Individuals who have clinically active depression defined according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria and scored on a validated depression assessment scale.
  • Individuals who have significant cognitive impairment and/or dementia as determined by a standardized neuropsychological battery.
  • Individuals who have a history of seizures.
  • Individuals who are immunocompromised.
  • Individuals who have an active infection.
  • Individuals who require diathermy, electroconvulsive therapy (ECT) or transcranial magnetic stimulation (TMS) to treat a chronic condition.
  • Individuals who have an implanted electronic device such as a neurostimulator, cardiac pacemaker or medication pump.
  • Individuals who, at the discretion of the research team member, lack the cognitive ability to understand the instructions and fully participate in research tasks.
  • Unable to understand written and spoken instructions in English. Individuals who carry a concomitant diagnosis that would preclude them from fully participating in the research tasks due to difficulties associated with comprehending instructions, cooperating with research tasks, or otherwise rendering the individuals incapable of participating in the research tasks. Examples could include a visual or hearing impairment preventing the individual from viewing a computer screen or hearing instructions.

Study Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Activa PC+S

Specific features of LFP recorded from the deep brain nuclei will be examined for possible correlation with different natural behaviors, such as movement, walking, or speech.

Interventions

Activa PC+S

Subjects will undergo placement of bilateral standard Deep Brain Stimulation (DBS) electrodes (Medtronic model 3387/3389) and implantation of the Activa PC+S, a modified impulse generator (IPG) for DBS with the added technology of neural signal recording.

Primary outcome measure

  • Specific features of local field potentials recorded from the deep brain nuclei during different natural behaviors, such as movement, walking, or speech. [ Time Frame: 3 years ]

Central Contacts and Locations

Central contacts

Sara Hanrahan, PhD

720-974-4093shanrahan@thecni.org

Locations

Colorado Neurological Institute

Recruiting

Englewood, Colorado, United States, 80113

Principal Investigator:

Adam O Hebb, MD

More Information

Sponsor

Colorado Neurological Institute

Last update posted

Feb 23, 2016

Last verified

Feb, 2016

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Colorado Neurological Institute on 2016-02-23.