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Novel Stimulation Patterns for the Treatment of Dystonia

NCT ID: NCT02468843

Last Updated: 2016-10-27

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

COMPLETED

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-07-31

Study Completion Date

2016-08-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Dystonia Cervical Dystonia

Keywords

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Deep brain stimulation DBS Dystonia DYT1

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Biphasic DBS stimulation

Intervention Type DEVICE

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 Scale

Intervention Type OTHER

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

Burke-Fahn- Marsden scale

Intervention Type OTHER

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

Interventions

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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)

Intervention Type DEVICE

Unified Dystonia Rating Scale

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

Intervention Type OTHER

Burke-Fahn- Marsden scale

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

Intervention Type OTHER

Other Intervention Names

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UDRS BFMDRS

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medtronic

INDUSTRY

Sponsor Role collaborator

University of Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Leonardo Almeida, MD

Role: PRINCIPAL_INVESTIGATOR

University of Florida Center for Movement Disorders and Neurorestoration

Locations

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Center for Movement Disorders and Neurorestoration

Gainesville, Florida, United States

Site Status

Countries

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United States

References

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Fakhar K, Hastings E, Butson CR, Foote KD, Zeilman P, Okun MS. Management of deep brain stimulator battery failure: battery estimators, charge density, and importance of clinical symptoms. PLoS One. 2013;8(3):e58665. doi: 10.1371/journal.pone.0058665. Epub 2013 Mar 11.

Reference Type BACKGROUND
PMID: 23536810 (View on PubMed)

Rawal PV, Almeida L, Smelser LB, Huang H, Guthrie BL, Walker HC. Shorter pulse generator longevity and more frequent stimulator adjustments with pallidal DBS for dystonia versus other movement disorders. Brain Stimul. 2014 May-Jun;7(3):345-9. doi: 10.1016/j.brs.2014.01.008. Epub 2014 Jan 18.

Reference Type BACKGROUND
PMID: 24548586 (View on PubMed)

Foutz TJ, McIntyre CC. Evaluation of novel stimulus waveforms for deep brain stimulation. J Neural Eng. 2010 Dec;7(6):066008. doi: 10.1088/1741-2560/7/6/066008. Epub 2010 Nov 17.

Reference Type BACKGROUND
PMID: 21084732 (View on PubMed)

Hofmann L, Ebert M, Tass PA, Hauptmann C. Modified pulse shapes for effective neural stimulation. Front Neuroeng. 2011 Sep 28;4:9. doi: 10.3389/fneng.2011.00009. eCollection 2011.

Reference Type BACKGROUND
PMID: 22007167 (View on PubMed)

Brocker DT, Grill WM. Principles of electrical stimulation of neural tissue. Handb Clin Neurol. 2013;116:3-18. doi: 10.1016/B978-0-444-53497-2.00001-2.

Reference Type BACKGROUND
PMID: 24112880 (View on PubMed)

Birdno MJ, Kuncel AM, Dorval AD, Turner DA, Gross RE, Grill WM. Stimulus features underlying reduced tremor suppression with temporally patterned deep brain stimulation. J Neurophysiol. 2012 Jan;107(1):364-83. doi: 10.1152/jn.00906.2010. Epub 2011 Oct 12.

Reference Type BACKGROUND
PMID: 21994263 (View on PubMed)

Swan BD, Grill WM, Turner DA. Investigation of deep brain stimulation mechanisms during implantable pulse generator replacement surgery. Neuromodulation. 2014 Jul;17(5):419-24; discussion 424. doi: 10.1111/ner.12123. Epub 2013 Oct 7.

Reference Type BACKGROUND
PMID: 24118257 (View on PubMed)

Beuter A, Lefaucheur JP, Modolo J. Closed-loop cortical neuromodulation in Parkinson's disease: An alternative to deep brain stimulation? Clin Neurophysiol. 2014 May;125(5):874-85. doi: 10.1016/j.clinph.2014.01.006. Epub 2014 Jan 18.

Reference Type BACKGROUND
PMID: 24555921 (View on PubMed)

Okun MS, Foote KD, Wu SS, Ward HE, Bowers D, Rodriguez RL, Malaty IA, Goodman WK, Gilbert DM, Walker HC, Mink JW, Merritt S, Morishita T, Sanchez JC. A trial of scheduled deep brain stimulation for Tourette syndrome: moving away from continuous deep brain stimulation paradigms. JAMA Neurol. 2013 Jan;70(1):85-94. doi: 10.1001/jamaneurol.2013.580.

Reference Type BACKGROUND
PMID: 23044532 (View on PubMed)

Related Links

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http://movementdisorders.ufhealth.org/

University of Florida Center for Movement Disorders \& Neurorestoration

Other Identifiers

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IRB201500366

Identifier Type: -

Identifier Source: org_study_id