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NCT06635811 · ClinicalTrials.gov registry record · NA

Circadian Adaptive DBS in Essential Tremor

A NA study of Essential Tremor, sponsored by University of Florida.

Recruiting
Registry status
NA
Development phase
25
Enrollment target
1
Study location

NCT06635811 is a NA study of Essential Tremor that is actively recruiting participants, run by University of Florida. The registered enrollment target is 25 participants, below the 402-participant average among 41 other Essential Tremor trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT06635811, a NA study of Essential Tremor, is actively recruiting participants, sponsored by University of Florida.

RECRUITING
Registry status
NA
Development phase
25 participants
Enrollment target
1
Study location

Study Summary

Deep brain stimulation (DBS) of the thalamus is an effective treatment for medically refractory essential tremor (ET). DBS involves delivering continuous stimulation to the brain through electrodes permanently implanted in the thalamus. Despite proven effectiveness, the long-term benefit of DBS can wane over time (habituation) and side effects, including paresthesia and dysarthria, often limit the amplitude of the stimulation, resulting in suboptimal control of tremor. In clinical practice, many groups advise patients to switch their devices off at night to avoid habituation and reduce side effects. However, manually turning off the device at night can result in uncontrolled tremor when the patient moves at night. This study aims to develop an algorithm that automatically turns off stimulation when a patient is asleep, based on circadian brain signals. Turning off stimulation could potentially improve the therapy by limiting adverse effects, increasing efficacy, reducing the risk of habituation, and prolonging battery life. This study will evaluate the feasibility, safety, and tolerability of circadian adaptive DBS.

Conditions Studied

Essential Tremor

Interventions

  • DEVICE Circadian Adaptive DBS
  • DEVICE Conventional DBS

Study Locations (1)

Florida

  • Norman Fixel Institute for Neurological Diseases - Gainesville

Trial Details

FieldValue
Enrollment Target 25 participants
Start Date 2025-05-01
Est. Completion 2029-10
Phase NA

Sponsor

University of Florida

1,106 total trials

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What the Registry Record Tells You About NCT06635811

The ClinicalTrials.gov registry entry for NCT06635811 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 402-participant average among 41 other Essential Tremor trials with a reported enrollment target (94% lower). The listed sponsor is University of Florida, which has 1,106 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Essential Tremor appearing as the primary indexed condition, and to 2 interventions - of which Circadian Adaptive DBS is the first listed.

NCT06635811 reports 1 study location spanning 1 distinct geographic area - top geographies include Florida.

Frequently Asked Questions

What is clinical trial NCT06635811 about?

NCT06635811 is a clinical study titled "Circadian Adaptive DBS in Essential Tremor". Deep brain stimulation (DBS) of the thalamus is an effective treatment for medically refractory essential tremor (ET). DBS involves delivering continuous stimulation to the brain through electrodes permanently implanted in the thalamus. Despite proven effectiveness, the long-term benefit of DBS can ...

What is the current status of trial NCT06635811?

This trial is currently recruiting. It is a NA study. The enrollment target is 25 participants. The study started on 2025-05-01. Estimated completion is 2029-10.

What conditions does trial NCT06635811 study?

This clinical trial studies the following conditions: Essential Tremor.

What interventions are being tested in trial NCT06635811?

The interventions under investigation include: Circadian Adaptive DBS (DEVICE), Conventional DBS (DEVICE).

Who is sponsoring clinical trial NCT06635811?

This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06635811 being conducted?

This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.