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Deep Brain Stimulation (DBS) for Early Stage Parkinson's Disease (PD) | Clinical Trials | Clareo Health

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Deep Brain Stimulation (DBS) for Early Stage Parkinson's Disease (PD)

Safety and Tolerability of Neurostimulation in Early Stage Parkinson's Disease

NCT00282152•Vanderbilt University Medical Center

Summary

Bilateral subthalamic nucleus deep brain stimulation (B-STN DBS) is one of the most effective surgical treatments for PD patients suffering from levodopa-induced motor complications. The relatively low incidence of permanent adverse effects and the potential for neuroprotection and alteration of the natural course of PD suggest a highly favorable benefit-to-risk ratio of this procedure. Since neuroprotection is best applied early in the disease course when there are more surviving neurons, we believe that further investigation of this procedure is warranted. The proposed pilot study will provide the necessary data to substantiate the safety and tolerability of the procedure as well as provide data for the design of a full-scale, multicenter trial to investigate the hypothesis that B-STN DBS is a safe and effective treatment to slow the progression of PD.

Detailed Description

This pilot trial is designed specifically to collect the preliminary safety and tolerability data necessary to conduct a future phase III clinical trial to investigate the hypothesis that deep brain stimulation of the subthalamic nucleus in subjects with early Parkinson's will slow the progression of the disease. The study design is a prospective, randomized, blinded, single-center trial comparing the safety and tolerability of B-STN DBS + Optimal Drug Therapy (ODT) vs. (ODT) alone (control, standard of care) in 30 subjects (15 per group) with early PD (Hoehn and Yahr stage II when off medication).

Eligibility

Age

50 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients must have a clinical diagnosis of probable idiopathic PD.
•Demonstrated response to dopaminergic therapy, defined as demonstrating at least 30% improvement in parkinsonian motor signs, based upon the UPDRS motor examination subscore, following the administration of their dopamine agonist (DA) drug(s) during the screening neurological examination.
•Hoehn and Yahr (H\&Y) stage II when OFF medication.
•No contraindications to surgery.
•Age between 50 and 75 years old.
•Available for follow-up for four years.
•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.
•Levodopa or dopamine agonist therapy for greater than six months but less than or equal to four years.

Exclusion Criteria

•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 implantable cardioverter defibrillators (ICD's).
•Patients who have medical conditions that require repeat MRI scans or diathermy treatments.
•Evidence of existing dyskinesias or motor fluctuations.

Key Dates

Start Date

March 1, 2006

Primary Completion Date

January 1, 2012

Completion Date

October 1, 2015

Last Updated

May 30, 2017

Enrollment

ACTUAL participants

Conditions

Parkinson's Disease

Interventions

B-STN DBS

DEVICE

Optimal drug therapy

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 30, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Deep Brain Stimulation (DBS) for Early Stage Parkinson's Disease (PD)

Inclusion Criteria

Exclusion Criteria

Research Into the Safety of a New Agent (VT-5006) in People With and Without Parkinson's Disease

Deep Brain Stimulation Therapy in Movement Disorders

Adaptive DBS Algorithm for Personalized Therapy in Parkinson's Disease (ADAPT-PD) China Study

A Study to Evaluate the Efficacy and Safety of Intravenous (IV) Prasinezumab in Participants With Early-Stage Parkinson's Disease

Effect of Striatal Temporal Interference Stimulation on Language Processing in Neurodegenerative Diseases

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