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Deep Brain Stimulation Effects in Dystonia

NCT04568681 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 7

Last updated 2022-07-15

No results posted yet for this study

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.

Conditions

  • Dystonia

Interventions

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.

Sponsors & Collaborators

  • University of Florida

    lead OTHER

Principal Investigators

  • Aysegul Gunduz, PhD · University of Florida

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-05
Primary Completion
2022-07-12
Completion
2022-07-12
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04568681 on ClinicalTrials.gov