Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06635811

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 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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Essential Tremor Central Nervous System Diseases Essential Tremor (ET) Essential Tremor, Movement Disorders Movement Disorders Nervous System Diseases

Age range

21 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Norman Fixel Institute for Neurological Diseases

Gainesville, Florida, 32608, United States

Location status: Recruiting

Location contact

Coralie de Hemptinne, PhD

PRINCIPAL_INVESTIGATOR

Julia C Gonzalez, BA

CONTACT

[email protected]

352-265-0111 ext. 32495

About this study

This single-center study will investigate the feasibility of developing an adaptive Deep brain stimulation (aDBS) strategy using thalamic circadian rhythm as a control signal. It will evaluate the safety and tolerability of aDBS compared to conventional DBS (cDBS) in a double-blinded cross-over design.

This study will recruit 25 Essential Tremor (ET) patients implanted with the bidirectional neural interface, Medtronic Percept PC (FDA approved), attached to DBS directional lead(s) (Sensight) implanted unilaterally or bilaterally in the ventral intermediate nucleus (VIM) and who are receiving adequate control of their tremor with VIM DBS.

First, the brain signal will be recorded for 1 month to identify circadian fluctuations that may be used to identify the period of sleep. Second, for each patient, an aDBS algorithm based on individualized brain activity will be developed and tested for 2 weeks in a double-blinded cross-over design comparing aDBS and cDBS. Third, at the end of this 4-week trial, patients who preferred aDBS will have the opportunity to stay on aDBS for 6 months, allowing to assess the long-term tolerability of the aDBS.

Each patient enrolled in this study will participate in 7 study visits over 8 months during which chronic brain recordings and aDBS will be set up. Symptoms and stimulation-induced side effects will be assessed by clinicians during these visits. Self-rating scales and wearable will be provided to track tremor, sleep, and movement at home.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosis of Essential Tremor confirmed by a Movement Disorders specialist following established criteria recommended by the Movement Disorders Society
  • Patients implanted with unilateral or bilateral VIM DBS leads attached to the Medtronic Percept DBS device for the treatment of Essential Tremor
  • Patients with clinical benefit of DBS as defined by a 30% improvement on the TRS or TETRAS at least 3 months after DBS implantation
  • DBS programmed in a monopolar configuration allowing chronic brain sensing (C+1- or C+2- in ring mode or any direction)
  • Be between 21 and 89 years old
  • Ability to give informed consent for the study

Exclusion criteria

  • Inability to comply with the study protocol
  • Pregnancy: all women of childbearing potential will have a negative urine pregnancy test prior to undergoing the study
  • Current active suicidal ideation (Yes to #2-5 on C-SSRS)
  • Any personality or mood symptoms that study personnel believe will interfere with study requirements

Treatment and study plan

Circadian Adaptive DBS

Device

DBS automatically turned off during sleep

Conventional DBS

Device

Continous DBS

Primary outcomes

  1. Presence of thalamic circadian rhythm

    Time frame: Baseline (first month of study participation)

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

  2. Incidence of stimulation-induced adverse events with aDBS compared to cDBS

    Time frame: Double-blind crossover period (second month of study participation)

    Adverse events are monitored the entire time subject is enrolled in study. Stimulation-induced adverse events during the double-blind crossover is a primary endpoint.

Secondary outcomes

  1. Patient's quality of life as assessed by the Quality of Life in Essential Tremor Questionnaire (QUEST), adapted for a 2-week assessment

    Time frame: From enrollment to the end of study (8 months)

    The QUEST is designed to evaluate the impact of essential tremor on daily functioning and well-being. The total score ranges from 0 to 120, with higher scores indicating worse quality of life.

  2. The Tremor Research Group Essential Tremor Rating Scale (TETRAS) Activities of Daily Living Subscale

    Time frame: From enrollment to the end of study (8 months)

    The TETRAS Activities of Daily Living Subscale will assess the ability to perform daily tasks. The total score ranges from 0 to 48, with higher scores indicating greater difficulty in performing tasks.

  3. Sleep quality as assessed by the Pittsburgh Sleep Quality Index (PSQI), adapted for a 2-week assessment

    Time frame: From enrollment to the end of study (8 months)

    The PSQI is used to assess the quality of sleep. PSQI score ranges from 0 to 21, with higher scores indicating poorer sleep quality. Each of the seven components of the PSQI is scored from 0 to 3, with 3 indicating the greatest dysfunction.

  4. Patient's cognition as assessed by the Montreal Cognitive Assessment 5-Minute Protocol (Mini MoCA)

    Time frame: From enrollment to the end of study (8 months)

    The Mini MoCA will be used to evaluate cognitive function in patients. It assesses short-term memory, executive function, verbal fluency, attention, and orientation. Scores range from 0 to 30, with higher scores indicating better cognitive performance.

  5. Patient's mood as assessed by the Beck Depression Inventory-II (BDI-II), adapted for a 2-week assessment

    Time frame: From enrollment to the end of study (8 months)

    The BDI-II will be used to assess depressive symptoms in patients. The questionnaire consists of 21 items, each rated on a scale from 0 to 3. Total scores range from 0 to 63, with higher scores indicating more severe depression. Scores are categorized as minimal (0-13), mild (14-19), moderate (20-28), and severe (29-63).

  6. Patient's impression as assessed by the Patient Global Impression of Change Scale (PGI-C)

    Time frame: From enrollment to the end of study (8 months)

    The PGI-C will be used to evaluate the patient's perception of improvement or worsening over time. The PGI-C is rated on a 7-point Likert scale, ranging from 1 (very much improved) to 7 (very much worse). Lower scores indicate better-perceived improvement, while higher scores reflect deterioration.

  7. Patient's self-report of side effects, tremor severity, and sleep

    Time frame: From enrollment to the end of study (8 months)

    At each study visit symptoms are assessed using our Custom Symptom Questionnaire (CSQ). Additionally, during the double-blind crossover period, side effects, tremor severity, and sleep is assessed daily using our Daily Assessment scale.

  8. Presence/severity of tremor tracked with wearable device

    Time frame: From enrollment to the end of double-blind crossover period (first two months of study)

    Subjects will be given a wearable device, a Fitbit watch, for objective assessment of tremor.

  9. Battery drainage/Stimulation energy use as assessed by Total Electrical Energy Delivered (TEED)

    Time frame: From enrollment to the end of study (8 months)

    The TEED will be calculated and compared for both aDBS and cDBS over a 2-week period. TEED is measured in millijoules (mJ), and lower values indicate lower energy consumption.

Study contacts

Contact information is provided by the study sponsor or research team.

Julia C Gonzalez, BA

CONTACT

[email protected]

(352) 265-0111 ext. 32495

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Official study title

Circadian Adaptive Deep Brain Stimulation in Essential Tremor

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
Oct 10, 2024
Registry last updated
Jul 30, 2026

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.