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Subthalamic Nucleus (STN) Versus Globus Pallidus (GPi) Trial

2014-08-27 03:15:36 | BioPortfolio

Summary

The goal of the second phase of the study is to determine if simultaneous bilateral subthalamic nucleus stimulation or simultaneous bilateral globus pallidus stimulation is more effective in reducing symptoms of Parkinson's Disease.

Description

Deep Brain Stimulation (DBS) is a promising therapy for Parkinson's disease (PD) Whether DBS is superior to comprehensive best medical therapy or whether some patients or symptoms respond better to DBS in one area of the brain or the other is currently not known. The goals of this project are to compare the effectiveness of DBS and comprehensive medical therapy as treatments for PD( Phase I) and to compare bilateral DBS at 2 areas of the brain-the subthalamic nucleus (STN) and the globus pallidus (GPi) -to determine the most effective brain site for surgical intervention (Phase II) In this prospective, randomized, multi-center trial, 316 patients will be enrolled at 13 centers over four and a half years. Patients will initially be randomized to immediate surgery (DBS) or to 6 months of "best medical therapy". BMT arm patients will then be randomized to proceed into the DBS surgical phase of the trial. The DBS site (STN pr GPi) will be assigned on a random basis at the time the patient enters the surgical phase of the trial. Patients will be followed for two years post surgery (24 months for DBS only patients and 30 months for BMT-DBS patients) Effective 8/5/05 randomization to the BMT arm has been discontinued since the study has sufficient information to compare the outcomes of DBS and BMT patients at 6 months. The findings will be critically important in establishing the optimal surgical treatment of the disabling symptoms of PD.

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Parkinson's Disease

Intervention

Bilateral Deep Brain Stimulation

Location

University of California at Los Angeles
Los Angeles
California
United States
90073

Status

Completed

Source

Department of Veterans Affairs

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:15:36-0400

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Phase I Deep Brain Stimulation (DBS) vs. Best Medical Therapy (BMT) Trial

The goals of this study are to determine if simultaneous bilateral subthalamic nucleus stimulation or simultaneous bilateral globus pallidus stimulation is more effective in reducing sympt...

Combined Subthalamic and Nucleus Basalis Meynert Deep Brain Stimulation for Parkinson's Disease With Dementia

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Deep Brain Stimulation for Parkinson's Disease Trial

The purpose of this trial is to evaluate the effect of deep brain stimulation in the the globus pallidus (Gpi) and the subthalamic nucleus (STN) on motor, neuropsychological and psychiatri...

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PubMed Articles [24970 Associated PubMed Articles listed on BioPortfolio]

Persistent adverse effects following different targets and periods after bilateral deep brain stimulation in patients with Parkinson's disease.

Performed as one of the major treatments for advanced Parkinson's disease (PD), deep brain stimulation (DBS) surgery can induce adverse effects (AEs) on cognition, gait, mood, speech and swallowing, w...

Acute dementia after deep brain stimulation in Parkinson's disease.

It is not clear whether cognitive adverse events can occur after subthalamic nuclei deep brain stimulation in Parkinson's disease, and the putative mechanisms are poorly understood.

Deep brain stimulation in Parkinson's disease.

Deep brain stimulation is an essential therapeutic tool in Parkinson's disease.

Bilateral subthalamic deep brain stimulation is an effective and safe treatment option for the older patients with Parkinson's disease.

We aimed to provide evidence that subthalamic nucleus (STN) deep brain stimulation (DBS) is an effective and safe treatment option for older patients with Parkinson's disease (PD).

Toe dystonia in Parkinson's disease: Impact of subthalamic nucleus deep brain stimulation.

Off state toe dystonia (TD) is a symptom frequently encountered in Parkinson's disease (PD), but little is known about its evolution after subthalamic nucleus deep brain stimulation (STN-DBS).

Medical and Biotech [MESH] Definitions

Therapy for MOVEMENT DISORDERS, especially PARKINSON DISEASE, that applies electricity via stereotactic implantation of ELECTRODES in specific areas of the BRAIN such as the THALAMUS. The electrodes are attached to a neurostimulator placed subcutaneously.

Stimulation of the brain, which is self-administered. The stimulation may result in negative or positive reinforcement.

Proteins associated with sporadic or familial cases of PARKINSON DISEASE.

A condition caused by the neurotoxin MPTP which causes selective destruction of nigrostriatal dopaminergic neurons. Clinical features include irreversible parkinsonian signs including rigidity and bradykinesia (PARKINSON DISEASE, SECONDARY). MPTP toxicity is also used as an animal model for the study of PARKINSON DISEASE. (Adams et al., Principles of Neurology, 6th ed, p1072; Neurology 1986 Feb;36(2):250-8)

A group of disorders which feature impaired motor control characterized by bradykinesia, MUSCLE RIGIDITY; TREMOR; and postural instability. Parkinsonian diseases are generally divided into primary parkinsonism (see PARKINSON DISEASE), secondary parkinsonism (see PARKINSON DISEASE, SECONDARY) and inherited forms. These conditions are associated with dysfunction of dopaminergic or closely related motor integration neuronal pathways in the BASAL GANGLIA.

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