Deep Brain Stimulation Effects in Dystonia

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

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.

Study Overview

• Status: Completed
• Conditions: Dystonia
• Intervention / Treatment: 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

• Study Type: Observational
• Enrollment (Actual): 7

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32611
      • University of Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Unified Dystonia Rating Scale (UDRS)	A clinical scale fo dystonia severity (0-4, 0:no symptoms, 4:extreme)	12 months
Burke-Fahn-Marsden Dystonia Rating Scale	A clinical scale fo dystonia severity (0-4, 0:no symptoms, 4:extreme)	12 months
Toronto Western Spasmodic Torticollis Rating Scale	A clinical scale of dystonia severity (0-4, 0:no symptoms, 4:extreme)	12 months

Collaborators and Investigators

• Sponsor: University of Florida
• Investigators: Principal Investigator: Aysegul Gunduz, PhD, University of Florida

Study record dates

Study Major Dates

• Study Start (Actual): November 5, 2020
• Primary Completion (Actual): July 12, 2022
• Study Completion (Actual): July 12, 2022

Study Registration Dates

• First Submitted: September 18, 2020
• First Submitted That Met QC Criteria: September 28, 2020
• First Posted (Actual): September 29, 2020

Study Record Updates

• Last Update Posted (Actual): July 15, 2022
• Last Update Submitted That Met QC Criteria: July 14, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Movement Disorders; Dyskinesias; Dystonia; Dystonic Disorders
• Other Study ID Numbers: IRB202002270

Drug and device information, study documents

• 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