Clinical trial NCT04568681: Deep Brain Stimulation Effects in Dystonia
Official title: Deep Brain Stimulation Effects in Dystonia: Time Course of Electrophysiological Changes in Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dystonia
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2020-09-29
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
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.

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.

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

Eligibility 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.

Primary outcomes:
measure: Unified Dystonia Rating Scale (UDRS)
timeFrame: 12 months
measure: Burke-Fahn-Marsden Dystonia Rating Scale
timeFrame: 12 months
measure: Toronto Western Spasmodic Torticollis Rating Scale
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Aysegul Gunduz, PhD
role: PRINCIPAL_INVESTIGATOR
References: