Circadian Adaptive DBS in Essential Tremor
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-89
SponsorUniversity of Florida
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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 design
Design model
Crossover
Treatments tested in this trial
Circadian Adaptive DBS
DeviceDBS automatically turned off during sleep
Conventional DBS
DeviceContinous DBS
Treatment groups
25 Participants
are divided into 2 treatment groupsGroup A: Adaptive DBS, Then Conventional DBSExperimental treatment 2 interventions
Group B: Conventional DBS, then Adaptive DBSExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline (first month of study participation)2
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.
Time frame
Double-blind crossover period (second month of study participation)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
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.
Time frame
From enrollment to the end of study (8 months)2
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.
Time frame
From enrollment to the end of study (8 months)3
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.
Time frame
From enrollment to the end of study (8 months)4
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.
Time frame
From enrollment to the end of study (8 months)Sponsors and contacts
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Source ClinicalTrials.gov