Dynamic Laryngotracheal Separation for Aspiration

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2004-08-31

Study Completion Date

2009-07-31

Brief Summary

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People who aspirate after neurologic insults such as stroke often develop fatal pneumonia. This study examines the effects of dynamic vocal cord closure on swallowing. Implants placed over the chest wall are connected to electrodes placed around the nerve that closes the vocal cords. The patient triggers closure by flipping the switch of a coil taped over the skin covering the internal stimulator. Vocal cord motion is verified by videotaping through an endoscope, and the status of swallowing is documented radiologically by a modified barium swallow.

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Detailed Description

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Data pending

Conditions

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Aspiration Pneumonia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Investigators

Study Groups

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2

Group Type EXPERIMENTAL

Placement of laryngeal implant

Intervention Type DEVICE

Placement of stimulator over anterior chest wall, and electrodes around recurrent laryngeal nerve, and tunneling leads between both

Interventions

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Placement of laryngeal implant

Placement of stimulator over anterior chest wall, and electrodes around recurrent laryngeal nerve, and tunneling leads between both

Intervention Type DEVICE

Other Intervention Names

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Modified Finetech Vocare Bladder stimulator Huntington perineural electrodes

Eligibility Criteria

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Inclusion Criteria

* Aspiration pneumonia after neurological insults (e.g. stroke)
* Ability to understand the purpose of the research
* Appropriate hand motor control
* Inability to improve under standard treatments (speech-language pathologists)
* Acceptance of a tracheostomy