CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 10 enrolled
Drug / intervention
Biphasic DBS stimulation +2 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02468843
NCT02468843N/ACompleted

Novel Stimulation Patterns and Personalized Deep Brain Stimulation for the Treatment of Dystonia

University of Florida·observational·Posted Jun 11, 2015·Updated Oct 27, 2016

In Brief

An observational study evaluating Biphasic DBS stimulation, Unified Dystonia Rating Scale, and 1 other intervention for Dystonia and Cervical Dystonia. Completed, enrolled 10 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsMedtronic

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedJun 11, 2015
Enrollment StartJul 1, 2015
Primary CompletionJan 1, 2016
Study CompletionAug 1, 2016
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 11.1 years ago

Interventions

Biphasic DBS stimulationdevice

The following protocol will be followed for each subject. In between, baseline and novel stimulation settings there will be a 30-minute washout period with DBS in the off state. 1. Current best/optimized DBS setting (considered "baseline") 2. DBS off for 30 minutes 3. Biphasic pulse stimulation mode (immediate assessment) 4. Biphasic pulse stimulation mode (assessment at 1h) 5. Biphasic pulse stimulation mode (assessment at 2h)

Unified Dystonia Rating Scaleother

Neurologist use the UDRS to determine the severity and duration of dystonia on 14 body areas.

Burke-Fahn- Marsden scaleother

Neurologist use the BFMDRS to rate the severity of dystonia in 9 regions of the body.