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Completed

NCT Number: NCT04581941

Deep Brain Stimulation Effects in Essential Tremor

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.

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Key information

Age range

21 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Florida

Gainesville, Florida, 32611, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Fahn- Tolosa- Marin Tremor Rating Scale

    Time frame: 6 months

    A clinical scale of tremor severity (0-4, 0:no symptoms, 4:extreme)

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Oct 9, 2020
Registry last updated
Oct 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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