Deep Brain Stimulation Effects in Essential Tremor

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04581941

Enrollment

Registered

2020-10-09

Start date

2020-12-05

Completion date

2024-05-30

Last updated

2024-10-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Essential Tremor

Brief summary

Deep Brain Stimulation (DBS) is an effective therapy for patients with medically refractory essential tremor. However, DBS programming is not standardized and multiple clinic visits are frequently required to adequately control symptoms. The investigators aim to longitudinally record brain signals from patients using a novel neurostimulator that can record brain signals. The investigators 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.

Detailed description

The development of newer technologies has allowed clinicians and researchers to better understand pathophysiological underpinnings of different disorders managed with neuromodulation. The is now the ability to stream brain signals from a newly FDA approved device, the Medtronic Percept. The investigators will study the longitudinal effects of DBS on the brain signals that are found to correlate with tremor severity as measured with wireless wearable sensors.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

21 Years to 85 Years

Healthy volunteers

Inclusion criteria

* Patient gives an informed consent. * Patient is over 21 years of age. * Having a diagnosis of a essential tremor 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 essential tremor; * Having comorbid neurodegenerative disorders that may affect mobility or cognition (e.g. comorbid Parkinson's disease or dystonia); * Having sequelae of prior brain insult (e.g. prior stroke or brain tumor); * History of prior resective brain surgery (e.g. tumor resection); * Not being a DBS candidate; * Receiving unilateral implants * Having a higher surgical risk that precludes patient from having standard intraoperative mapping.

Design outcomes

Primary

Measure	Time frame	Description
Fahn- Tolosa- Marin Tremor Rating Scale	6 months	A clinical scale of tremor severity (0-4, 0:no symptoms, 4:extreme)

Countries

United States

Outcome results