Interphase Gap in Biphasic Stimulation in DBS for ET
Not Applicable
Completed
- Conditions
- Essential Tremor
- Interventions
- Device: Study Tool Computer
- Registration Number
- NCT05177900
- Lead Sponsor
- Myles Mc Laughlin
- Brief Summary
Deep Brain Stimulation (DBS) is a well established therapy in medication-refractory essential tremor (ET). Since the inception of DBS, cathodic pulses are used. Recent work suggests that biphasic pulses influence the therapeutic window when compared to cathodic pulses, when tested acutely. Animal studies and work from cochlear implants, show that the use of an interphase gap, influences the generation of action potentials. In this study, the goal is to investigate the use of an interphase gap in biphasic pulses in DBS for ET patients.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 9
Inclusion Criteria
- Patients with essential tremor treated with Vim-DBS
- Normal impedances of DBS circuit
- Signed written informed consent
Exclusion Criteria
- Active psychiatric disease or active alcohol or drug abuse
- Dementia
- History of recurrent or unprovoked seizures
- Relevant comorbidities that influence objective clinical assessment
- Pregnancy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Biphasic pulse with interphase gap Study Tool Computer - Biphasic pulse without interphase gap Study Tool Computer -
- Primary Outcome Measures
Name Time Method Therapeutic threshold (mA) During uptitration of the amplitude (entire process takes 3-4 minutes) Amplitude needed to elicit tremor arrest, expressed in milliamperes (mA)
Side effect threshold (mA) During uptitration of the amplitude (entire process takes 3-4 minutes) Amplitude needed to elicit non-transient side effects, expressed in milliamperes (mA)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
UZ Leuven
🇧🇪Leuven, Belgium