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NCT02468843 · ClinicalTrials.gov registry record
Novel Stimulation Patterns for the Treatment of Dystonia
A clinical trial, sponsored by University of Florida.
- Completed
- Registry status
- 10
- Enrollment target
NCT02468843 is a clinical trial that has completed, run by University of Florida. The registered enrollment target is 10 participants.
The verdict
NCT02468843 has completed, sponsored by University of Florida.
- COMPLETED
- Registry status
- 10 participants
- Enrollment target
Study Summary
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-Onset Primary Dystonia(DYT1) mutations and other dystonia subtypes). DBS patients typically experience significant improvement in disabling symptoms; however, detailed programming is always required, and stimulation-induced side effects commonly emerge. Clinicians may empirically vary voltage, pulse width, frequency and also the active contacts on the DBS lead to achieve observed optimal benefits. The majority of DBS patients undergo repeat surgeries to replace the implantable pulse generator (IPG) every 2.5 to 5 years. It has been demonstrated that, in dystonia patients, that higher settings are required for adequate symptomatic control, and that neurostimulators have a considerably shorter life when compared to neurostimulators from patients with essential tremor or Parkinson's disease. Additionally, several smaller studies have suggested that alternative pulse stimulation properties and pulse shape modifications can lower IPG battery consumption. Newer patterns of stimulation (regularity of pulses and shapes of pulses) have not been widely tested in clinical practice, and are not part of the current FDA device labeling. Novel patterns of stimulation do however, have the potential to improve symptoms, reduce side effects, and to preserve the neurostimulator life. The current research proposal will prospectively study biphasic pulse stimulation paradigms and its effects on dystonic symptoms. The investigators aim to demonstrate that we can tailor DBS settings to address dystonia symptoms, improve the safety profile, characterize distinct clinical advantages, and carefully document the safety and neurostimulator battery consumption profile for biphasic stimulation.
Interventions
- DEVICE Biphasic DBS stimulation
- OTHER Unified Dystonia Rating Scale
- OTHER Burke-Fahn- Marsden scale
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2015-07 |
| Est. Completion | 2016-08 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02468843
The ClinicalTrials.gov registry entry for NCT02468843 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Florida, which has 1,106 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Biphasic DBS stimulation is the first listed.
NCT02468843 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02468843 about?
NCT02468843 is a clinical study titled "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-Onset Primary Dystonia(DYT1) mutations and other dystonia subtypes). DBS patients typically experience significant i...
What is the current status of trial NCT02468843?
This trial is currently completed. The enrollment target is 10 participants. The study started on 2015-07. Estimated completion is 2016-08.
What interventions are being tested in trial NCT02468843?
The interventions under investigation include: Biphasic DBS stimulation (DEVICE), Unified Dystonia Rating Scale (OTHER), Burke-Fahn- Marsden scale (OTHER).
Who is sponsoring clinical trial NCT02468843?
This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.
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