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Completed

NCT Number: NCT04568681

Deep Brain Stimulation Effects in Dystonia

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Florida

Gainesville, Florida, 32611, United States

About this study

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

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Deep Brain Stimulation (DBS)

Device

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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Official study title

Deep Brain Stimulation Effects in Dystonia: Time Course of Electrophysiological Changes in Treatment

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Sep 29, 2020
Registry last updated
Jul 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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