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Novel Stimulation Patterns for the Treatment of Dystonia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02468843
Recruitment Status : Completed
First Posted : June 11, 2015
Last Update Posted : October 27, 2016
Information provided by (Responsible Party):
University of Florida

Brief 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.

Condition or disease Intervention/treatment
Dystonia Cervical Dystonia Device: Biphasic DBS stimulation Other: Unified Dystonia Rating Scale Other: Burke-Fahn- Marsden scale

Detailed Description:

In this research study, different stimulation patterns on the DBS device will be tried for effectiveness against current symptoms. There will be two different stimulation patterns that will be performed and can occur at different clinic dates. Each of the stimulation patterns will have times varying between 2-3 hours per stage. One part of the study will deliver stimulation in a continuous manner, while the other part of the study will deliver stimulation based upon responses obtained from changes in brain wave patterns. These procedures can be performed while in the clinic for regular programming visits or at different visits. The current DBS setting will be recorded and at the end of the session the setting will be reset to back to the previous settings. The participant will have the option of participating in both or just one part.

During the visit, the participant will be analyzed for tremor and slowness by using the Trigno wireless Electromyography (EMG) and the Kinesia system. The system includes a unit composed of two modules: a wrist module, which is the size of an I-Pod and will be attached to the wrist over a comfortable wristband, and a sensor module, which will be placed over the index finger.

The entire visit will be videotaped and UDRS (Unified Dystonia Disease Rating Scale) and BFMDRS (Burke-Fahn-Marsden Dystonia Rating Scale) scores will be evaluated by two scorers. Pre-DBS "off" and "on" scores will also be taken.

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Study Type : Observational
Actual Enrollment : 10 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Novel Stimulation Patterns and Personalized Deep Brain Stimulation for the Treatment of Dystonia
Study Start Date : July 2015
Actual Primary Completion Date : January 2016
Actual Study Completion Date : August 2016

Group/Cohort Intervention/treatment
Biphasic DBS stimulations
Subjects in this group with have Biphasic DBS stimulation setting performed, Unified Dystonia Rating Scale (UDRS), and Burke-Fahn- Marsden scale (BFMDRS), tremor accelerometer, kinesia accelerometer, and GaitRite walking assessments performed.
Device: Biphasic DBS stimulation

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)

Other: Unified Dystonia Rating Scale
Neurologist use the UDRS to determine the severity and duration of dystonia on 14 body areas.
Other Name: UDRS

Other: Burke-Fahn- Marsden scale
Neurologist use the BFMDRS to rate the severity of dystonia in 9 regions of the body.
Other Name: BFMDRS

Primary Outcome Measures :
  1. Blinded Unified Dystonia Rating Scale (UDRS) [ Time Frame: Day 1 ]
    Neurologist use the UDRS to determine the severity and duration of dystonia on 14 body areas. Each body region is assessed and scores range from 0 (no dystonia) to 4 (extreme dystonia). The maximum UDRS score is 112 and includes severity and duration factors.

  2. Burke-Fahn-Marsden Dystonia Rating Scale (BFMDRS) [ Time Frame: Day 1 ]
    Neurologist use the BFMDRS to rate the severity of dystonia in 9 regions of the body. Provoking and severity factors are ranked from 0 (no dystonia) to 4 (extreme dystonia) for each body region and then adjusted scores are summed to give an overall score from 0 to 120.

Secondary Outcome Measures :
  1. Tremor accelerometer to measure motor dysfunction [ Time Frame: Day 1 ]
    Tremor accelerometer for the patients with a component of dystonic tremor (device taped or attached to the wrist by an elastic band to record how fast the tremor).

  2. Kinesia accelerometer to measure motor dysfunction [ Time Frame: Day 1 ]
    Kinesia accelerometer for the patients with a mobile component of dystonia (device attached to the arms and legs (by an elastic band or tape) to record movements).

  3. Battery Consumption compared between pre and post settings [ Time Frame: Day 2 ]
    Battery consumption will be calculated and compared between the NEW settings and patients' baseline settings. The Medtronic battery estimator helpline will be used to calculate battery life, as well as the University of Florida calculator.

  4. GaitRite walking assessment. [ Time Frame: Day 1 ]
    The GaitRite is an automated floor that when you walk on the floor it records your gait pattern.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
This is a preliminary pilot investigation that will utilize a within subjects study design and will screen 10 generalized dystonia and screen 10 cervical dystonia patients.

Inclusion Criteria:

  • Diagnosis of primary generalized dystonia or cervical dystonia
  • Bilaterally implanted globus pallidus interus(GPi) DBS.
  • Minimum of 6 months of chronic stimulation
  • Greater than 60 days on stable DBS settings

Exclusion Criteria:

  • Does not have DBS for dystonia or cervical dystonia

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02468843

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United States, Florida
Center for Movement Disorders and Neurorestoration
Gainesville, Florida, United States, 32607
Sponsors and Collaborators
University of Florida
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Principal Investigator: Leonardo Almeida, MD University of Florida Center for Movement Disorders and Neurorestoration
Additional Information:

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Responsible Party: University of Florida Identifier: NCT02468843    
Other Study ID Numbers: IRB201500366
First Posted: June 11, 2015    Key Record Dates
Last Update Posted: October 27, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by University of Florida:
Deep brain stimulation
Additional relevant MeSH terms:
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Dystonic Disorders
Neurologic Manifestations
Nervous System Diseases
Movement Disorders
Central Nervous System Diseases