Essential TremorNCT06635811
Circadian Adaptive DBS in Essential Tremor
A study testing Circadian Adaptive DBS and Conventional DBS in people with Essential Tremor and Essential Tremor (ET), run by University of Florida at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 89 years
- Conditions the study is for
- Essential Tremor, Essential Tremor (ET), Essential Tremor, Movement Disorders
- What is being tested?
- Circadian Adaptive DBS and Conventional DBS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2025to Oct 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Norman Fixel Institute for Neurological Diseases
Gainesville, Florida, 32608
Julia C Gonzalez, BA, 352-265-0111 ext. 32495, Julia.Gonzalez@neurology.ufl.edu
Coralie de Hemptinne, PhD
About this study
Official title: Circadian Adaptive Deep Brain Stimulation 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.
Read the detailed description
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.
- Being tested
- Circadian Adaptive DBS, Conventional DBS
- Keywords
- Deep Brain Stimulation, DBS, Adaptive DBS, Adaptive Deep Brain Stimulation, Circadian
- Medical subject headings
- Essential Tremor, Movement Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Circadian Adaptive DBSDevice
DBS automatically turned off during sleep
Conventional DBSDevice
Continous DBS
| Study group | Role | What they receive |
|---|---|---|
| Adaptive DBS, Then Conventional DBS | Experimental | Participants will initially have their DBS programmed to automatically turn off during sleep for 2 weeks. Then, they will transition to continuous stimulation for another 2 weeks. Receives: Device: Circadian Adaptive DBS; Device: Conventional DBS |
| Conventional DBS, then Adaptive DBS | Experimental | Participants will initially have their DBS programmed with continuous stimulation for 2 weeks. Then, they will transition to having their DBS automatically turned off during sleep for another 2 weeks. Receives: Device: Circadian Adaptive DBS; Device: Conventional DBS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of thalamic circadian rhythm
Thalamic circadian rhythm is defined as a significant difference in day vs night brain activity. It can be used to set up adaptive DBS.
Measured: Baseline (first month of study participation)
Incidence of stimulation-induced adverse events with aDBS compared to cDBS
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.
Measured: Double-blind crossover period (second month of study participation)
Secondary outcomes (9)
Patient's quality of life as assessed by the Quality of Life in Essential Tremor Questionnaire (QUEST), adapted for a 2-week assessment
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.
Measured: From enrollment to the end of study (8 months)
The Tremor Research Group Essential Tremor Rating Scale (TETRAS) Activities of Daily Living Subscale
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.
Measured: From enrollment to the end of study (8 months)
Sleep quality as assessed by the Pittsburgh Sleep Quality Index (PSQI), adapted for a 2-week assessment
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.
Measured: From enrollment to the end of study (8 months)
Patient's cognition as assessed by the Montreal Cognitive Assessment 5-Minute Protocol (Mini MoCA)
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.
Measured: From enrollment to the end of study (8 months)
Patient's mood as assessed by the Beck Depression Inventory-II (BDI-II), adapted for a 2-week assessment
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).
Measured: From enrollment to the end of study (8 months)
Patient's impression as assessed by the Patient Global Impression of Change Scale (PGI-C)
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.
Measured: From enrollment to the end of study (8 months)
Patient's self-report of side effects, tremor severity, and sleep
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.
Measured: From enrollment to the end of study (8 months)
Presence/severity of tremor tracked with wearable device
Subjects will be given a wearable device, a Fitbit watch, for objective assessment of tremor.
Measured: From enrollment to the end of double-blind crossover period (first two months of study)
Battery drainage/Stimulation energy use as assessed by Total Electrical Energy Delivered (TEED)
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.
Measured: From enrollment to the end of study (8 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2024
- Study start1 May 2025
- Primary completionOct 2028 (estimated)
- Study completionOct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Essential TremorStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06635811
- Sponsor's protocol ID
- IRB202400652
- Status last verified
- Jul 2026
- First submitted
- 13 Sep 2024
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circadian Adaptive Deep Brain Stimulation in Essential Tremor
- ClinicalTrials.gov ID
- NCT06635811
- Acronym / sponsor ID
- IRB202400652
- Keywords
- Deep Brain Stimulation, DBS, Adaptive DBS, Adaptive Deep Brain Stimulation, Circadian
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Oct 2029 (estimated)
- First posted
- 10 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adaptive DBS, Then Conventional DBS | Experimental | Device: Circadian Adaptive DBS, Device: Conventional DBSParticipants will initially have their DBS programmed to automatically turn off during sleep for 2 weeks. Then, they will transition to continuous stimulation for another 2 weeks. |
| Conventional DBS, then Adaptive DBS | Experimental | Device: Circadian Adaptive DBS, Device: Conventional DBSParticipants will initially have their DBS programmed with continuous stimulation for 2 weeks. Then, they will transition to having their DBS automatically turned off during sleep for another 2 weeks. |
Who may qualify
- Ages
- 21 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Circadian Adaptive DBSDBS automatically turned off during sleep | Device | Adaptive DBS, Then Conventional DBS, Conventional DBS, then Adaptive DBS |
| Conventional DBSContinous DBS | Device | Adaptive DBS, Then Conventional DBS, Conventional DBS, then Adaptive DBS |
Primary outcome
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.
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.
9 secondary outcomes
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 Tremor Research Group Essential Tremor Rating Scale (TETRAS) Activities of Daily Living Subscale
Time frame: From enrollment to the end of study (8 months)
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)
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)
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)
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)
Patient's self-report of side effects, tremor severity, and sleep
Time frame: From enrollment to the end of study (8 months)
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)
Battery drainage/Stimulation energy use as assessed by Total Electrical Energy Delivered (TEED)
Time frame: From enrollment to the end of study (8 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
Related trials for Essential Tremor
Recruiting
Effects of Microelectrode-based Brain Stimulation in Humans
Essential Tremor, Parkinsons Disease (PD)
Recruiting
Deep Brain Stimulation Surgery for Movement Disorders
Parkinson's Disease, Essential Tremor
RecruitingObservational study
The Encora X1™ in a Real World Observational Study
Essential Tremor
Active, not recruitingObservational study
Identifying Markers of Disease Subtypes and Disease Progression in the Syndrome of Essential Tremor
Essential Tremor
RecruitingPhase 2
Study of AGN-151607-DP to Assess Adverse Events and Change in Disease Activity in Adult Participants With Upper Limb Essential Tremor
Upper Limb Essential Tremor
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Circadian Adaptive DBS and Conventional DBS in people with Essential Tremor and Essential Tremor (ET), run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Julia C Gonzalez, BA ((352) 265-0111 ext. 32495, Julia.Gonzalez@neurology.ufl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of thalamic circadian rhythm (time frame: Baseline (first month of study participation)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026.