Deep Brain Stimulation Effects in Dystonia

NCT04568681 | Completed FDA Device

• 1 other identifier: IRB202002270
• Study Type: observational
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Dystonia

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

Patients with dystonia

Patients with dystonia who have clinically been deemed candidates for DBS surgery.

Device: Deep brain stimulation (DBS)

Interventions

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.

Patients with dystonia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

University of Florida

Gainesville, Florida, 32611, United States

Location

MeSH Terms

Conditions

Dystonia

Interventions

Deep Brain Stimulation

Condition Hierarchy (Ancestors)

Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Surgical Procedures, Operative

Study Officials

• Aysegul Gunduz, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2020
• First Posted: September 29, 2020
• Study Start: November 5, 2020
• Primary Completion: July 12, 2022
• Study Completion: July 12, 2022
• Last Updated: July 15, 2022

Record last verified: 2022-07

Locations

US (1)