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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: Recruiting NA study of Essential Tremor, sponsored by University of Florida.

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

Thalamic circadian rhythm is defined as a significant difference in day vs night brain activity. It can be used to set up adaptive DBS.

Conditions Studied

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
University of Florida

1,106 total trials

What NCT06635811 shows while recruiting

NCT06635811 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 402-participant average among 41 other Essential Tremor trials with a reported enrollment target (94% lower).

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 a single indexed study location in 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.

Similar trials for Essential Tremor

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT06635811's enrollment target sits among peer trials

25 29th of 41 higher than 12 of 41 other Essential Tremor trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Essential Tremor trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT06635811, the US trial registry maintained by the National Library of Medicine. NCT06635811 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.