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Deep Brain Stimulation Effects in Dystonia

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ClinicalTrials.gov Identifier: NCT04568681
Recruitment Status : Completed
First Posted : September 29, 2020
Last Update Posted : July 15, 2022
Sponsor:
Information provided by (Responsible Party):
University of Florida

Brief Summary:
Deep Brain Stimulation (DBS) is an effective therapy for patients with medically refractory primary dystonia. However, DBS programming for dystonia is not standardized and multiple clinic visits are frequently required to adequately control symptoms. We aim to longitudinally record brain signals from patients using a novel neurostimulator that can record brain signals. We will correlate brain signals to clinical severity scores to identify pathological rhythms in the absence of DBS, and we will study the effects of DBS on these signals in order to guide clinical programming. We are going to recruit patients who receive the Medtronic Percept device, which allows for brain signal recordings (this feature is FDA approved). The investigators will be conducting an observational study using this device to collect data that the subjects receive as standard of care.

Condition or disease Intervention/treatment
Dystonia Device: Deep brain stimulation (DBS)

Detailed Description:
The development of newer technologies has allowed clinicians and researchers to better understand pathophysiological underpinnings of different disorders managed with neuromodulation. There is a paucity of information, however, on dystonia, likely due to its rarity of cases and variability in phenomenology to allow generalization of findings. Possible abnormal brain signals, such as high activity in theta band (defined as rhythms in the 4-12Hz range ), have been proposed by small case series. The development of newer technologies has allowed clinicians and researchers to better understand pathophysiological underpinnings of different disorders managed with neuromodulation. There is a paucity of information, however, on dystonia, likely due to its rarity of cases and variability in phenomenology to allow generalization of findings. Possible abnormal brain signals, such as high activity in theta band (defined as rhythms in the 4-12Hz range ), have been proposed by small case series

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Study Type : Observational
Actual Enrollment : 7 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Deep Brain Stimulation Effects in Dystonia: Time Course of Electrophysiological Changes in Treatment
Actual Study Start Date : November 5, 2020
Actual Primary Completion Date : July 12, 2022
Actual Study Completion Date : July 12, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dystonia

Group/Cohort Intervention/treatment
Patients with dystonia
Patients with dystonia who have clinically been deemed candidates for DBS surgery.
Device: Deep brain stimulation (DBS)
Deep brain stimulation is an FDA approved therapy that involves surgical implantation of electrodes in deep brain targets and an implantable pulse generator delivers electrical pulses.




Primary Outcome Measures :
  1. Unified Dystonia Rating Scale (UDRS) [ Time Frame: 12 months ]
    A clinical scale fo dystonia severity (0-4, 0:no symptoms, 4:extreme)

  2. Burke-Fahn-Marsden Dystonia Rating Scale [ Time Frame: 12 months ]
    A clinical scale fo dystonia severity (0-4, 0:no symptoms, 4:extreme)

  3. Toronto Western Spasmodic Torticollis Rating Scale [ Time Frame: 12 months ]
    A clinical scale of dystonia severity (0-4, 0:no symptoms, 4:extreme)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Patients with dystonia, who have been cleared for DBS surgery or receiving a battery change who will receive the Percept battery.
Criteria

Inclusion Criteria:

  • Patient gives an informed consent.
  • Patient is over 18 years of age.
  • Having a diagnosis of a primary dystonia confirmed by a trained movement disorders neurologist;
  • Having failed or not tolerated conventional medical management, at the discretion of the neurologist managing the patient;

Exclusion Criteria:

  • Having alternative diagnoses to a primary dystonic syndrome;
  • Having comorbid neurodegenerative disorders that may affect mobility or cognition (e.g. comorbid Parkinson's disease);
  • Having sequelae of prior brain insult (e.g. prior stroke or brain tumor);
  • History of prior resectivebrain surgery (e.g. tumor resection);
  • Not being a DBS candidate;
  • Selection of alternative targets to conventional GPi;
  • Receiving unilateral implants
  • Having a higher surgical risk that precludes patient from having standard intraoperative mapping.

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 ClinicalTrials.gov identifier (NCT number): NCT04568681


Locations
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United States, Florida
University of Florida
Gainesville, Florida, United States, 32611
Sponsors and Collaborators
University of Florida
Investigators
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Principal Investigator: Aysegul Gunduz, PhD University of Florida
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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT04568681    
Other Study ID Numbers: IRB202002270
First Posted: September 29, 2020    Key Record Dates
Last Update Posted: July 15, 2022
Last Verified: July 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Dystonia
Dystonic Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Movement Disorders
Central Nervous System Diseases