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Deep Brain Stimulation in Treating Patients With Dystonia

2014-08-27 03:58:14 | BioPortfolio

Summary

RATIONALE: Dystonia is a disorder in which the muscles that control voluntary movements are persistently or intermittently contracted (not relaxed). Deep brain stimulation is provided by a small, battery operated implant placed under the skin of the chest that delivers low voltage electrical pulses through a wire under the skin that is connected to a specific area of the brain. Deep brain stimulation may help lessen the symptoms of dystonia.

PURPOSE: Phase II/III trial to study the effectiveness of deep brain stimulation in treating patients who have dystonia.

Description

PROTOCOL OUTLINE: Patients undergo surgery to implant a brain stimulation system consisting of an implanted pulse generator (IPG) in the chest and a wire lead in the globus pallidum internal. After the lead has been implanted, the brain stimulation system is tested. Patients are examined at 1, 3, 6, 9, and 12 months after surgery. A double blinded evaluation, during which the IPG is either off or on, is carried out at 3 and 6 months.

Patients are followed every 3 months as long as the brain stimulation system remains in place.

Study Design

Primary Purpose: Treatment

Conditions

Dystonia

Intervention

implanted pulse generator

Location

Mount Sinai Medical Center, NY
New York
New York
United States
10029

Status

Completed

Source

FDA Office of Orphan Products Development

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:58:14-0400

Clinical Trials [561 Associated Clinical Trials listed on BioPortfolio]

Novel Stimulation Patterns for the Treatment of Dystonia

Deep brain stimulation (DBS) is an effective surgical therapy for select Dystonia patients who are refractory to medications or who have generalized symptoms (e.g. patients with Early-Onse...

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Dystonia is a disorder characterized by excessive involuntary contraction of muscles with repetitive and patterned movements. The primary focal dystonias are the most common type of dyston...

Humanitarian Device Exemption

The purpose of this study is to allow patients to undergo deep brain stimulation (DBS) surgery for the treatment of dystonia. This is NOT a research study, but rather, a requirement by th...

PubMed Articles [1439 Associated PubMed Articles listed on BioPortfolio]

Clinical Efficacy of Bilateral Deep Brain Stimulation Does Not Change After Implantable Pulse Generator Replacement but the Impedances Do: A Prospective Study.

Deep brain stimulation (DBS) is an approved therapy option for movement disorders such as Parkinson's disease (PD), essential Tremor (ET), and dystonia. While current research focuses on rechargeable ...

Reoperation for device infection and erosion following deep brain stimulation implantable pulse generator placement.

Infection and erosion following implantable pulse generator (IPG) placement are associated with morbidity and cost for patients with deep brain stimulation (DBS) systems. Here, the authors provide a d...

Parallel optical random bit generator.

We present an optical approach for high-speed parallel random bit generation based on stochastic pulse-to-pulse fluctuation in the supercontinuum (SC). Through spectrally demultiplexing the SC pulse s...

Clinical outcomes of pallidal deep brain stimulation for dystonia implanted using intraoperative MRI.

Lead placement for deep brain stimulation (DBS) using intraoperative MRI (iMRI) relies solely on real-time intraoperative neuroimaging to guide electrode placement, without microelectrode recording (M...

Cognitive correlates of prospective memory in dystonia.

Executive dysfunctions are observed in focal dystonia (i.e., blepharospasm and cervical dystonia). Prospective memory (PM) is the ability to remember to carry out intended actions in the future and pl...

Medical and Biotech [MESH] Definitions

The lack of development of SEXUAL MATURATION in boys and girls at a chronological age that is 2.5 standard deviations above the mean age at onset of PUBERTY in a population. Delayed puberty can be classified by defects in the hypothalamic LHRH pulse generator, the PITUITARY GLAND, or the GONADS. These patients will undergo spontaneous but delayed puberty whereas patients with SEXUAL INFANTILISM will not.

Use of a pulse of X-rays or fast electrons to generate free radicals for spectroscopic examination.

Evaluation of the contour of the PULSE waves which vary in different parts of the circulation and depend on physiological as well as pathophysiological conditions of the individual.

Acquired and inherited conditions that feature DYSTONIA as a primary manifestation of disease. These disorders are generally divided into generalized dystonias (e.g., dystonia musculorum deformans) and focal dystonias (e.g., writer's cramp). They are also classified by patterns of inheritance and by age of onset.

An attitude or posture due to the co-contraction of agonists and antagonist muscles in one region of the body. It most often affects the large axial muscles of the trunk and limb girdles. Conditions which feature persistent or recurrent episodes of dystonia as a primary manifestation of disease are referred to as DYSTONIC DISORDERS. (Adams et al., Principles of Neurology, 6th ed, p77)

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