Hub and Spoke, Comparative Outcomes for Parkinson's Disease Treated With Deep Brain Stimulation

NCT02541617 | Withdrawn

• 1 other identifier: 150174
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Outcomes study to test the hypothesis that patients first identified by community-based neurologists, implanted by a networked movement disorders center, and then managed by the same community-based neurologist will have clinical outcomes comparable to movement disorders centers.

Conditions

Parkinson's Disease

Outcome Measures

Primary Outcomes (1)

• UPDRS part IV

  Change in score from baseline, complication of medical therapy for Parkinson's disease

  one year

Secondary Outcomes (10)

• UPDRS

  One Year

• PDQ-39

  One year

• Obeso Dyskinesia Rating Scale

  One year

• Hoehn and Yahr rating

  One year

• Schwab and England ADL score

  One year

Study Arms (2)

Movement Disorder Center

ACTIVE COMPARATOR

Device programming, Deep Brain stimulator will be programmed at the implanting center, standard of care

Procedure: Standard of care

Programming by community Neurologist

EXPERIMENTAL

Device programming, Deep Brain Stimulator will be programmed by community Neurologist

Procedure: Programming by community Neurologist

Interventions

Programming by community Neurologist PROCEDURE

Deep Brain stimulator with be programmed by a community Neurologist

Programming by community Neurologist

Standard of care PROCEDURE

Deep Brain Stimulator will be programmed with at the implanting movement disorders center

Movement Disorder Center

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have a clinical diagnosis of probable idiopathic PD. The diagnosis will be based upon the presence of at least three of four clinical features according to diagnostic utility (Resting Tremor, Bradykinesia, Rigidity, Asymmetric Onset) and an absence of clinical features suggestive of an alternative diagnosis.
• Demonstrated response to dopaminergic therapy. In order to exclude patients with a possible alternative diagnosis, all subjects included in the study must have demonstrated a good response to DA drugs, defined as demonstrating at least 30% improvement in parkinsonian motor signs, based upon the UPDRS motor examination subscore, following the administration of their DA drug(s) during the screening neurological examination.
• Advanced Parkinson's disease.
• No contraindications to surgery.
• Age between 50 and 75 years old.
• Available for follow-up for the entire duration of the study.
• Informed Consent: The subject understands the risks, benefits, and alternatives to the study procedures and participation in the study.
• MRI within normal range for age

You may not qualify if:

• Evidence of an alternative diagnosis or secondary parkinsonism, as suggested by features unusual early in the clinical course: Prominent postural instability, freezing phenomena, or hallucinations unrelated to medications in the first 3 years after symptom onset; dementia preceding motor symptoms; supranuclear gaze palsy (other than restriction of upward gaze) or slowing of vertical saccades in the first year; severe, symptomatic dysautonomia unrelated to medications; documentation of a condition known to produce parkinsonism and plausibly connected to the subject's symptoms (such as suitably located focal brain lesions or neuroleptic use within the past 6 months)
• Uncontrolled medical condition or clinically significant medical disease that would increase the risk of developing pre- or postoperative complications (e.g., significant cardiac or pulmonary disease, uncontrolled hypertension).
• Evidence of dementia
• Major psychiatric disorder
• Previous brain operation or injury.
• Active participation in another clinical trial for the treatment of PD.
• Patients who have demand cardiac pacemakers or who have medical conditions that require repeat MRI scans.

Sponsors & Collaborators

• Vanderbilt University: lead
• Medtronic: collaborator

MeSH Terms

Conditions

Parkinson Disease

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Fenna T Phibbs, MD

  Vanderbilt Univeristy Medical center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Neurology

Study Record Dates

• First Submitted: April 22, 2015
• First Posted: September 4, 2015
• Study Start: January 1, 2016
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2018
• Last Updated: April 27, 2017

Record last verified: 2016-11