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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Biphasic pulse without interphase gap | Active Comparator |
| |
| Biphasic pulse with interphase gap | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Study Tool Computer | Device | Nonconventional pulses delivered with custom-ware designed by Boston Scientific |
|
| Measure | Description | Time Frame |
|---|---|---|
| Therapeutic threshold (mA) | Amplitude needed to elicit tremor arrest, expressed in milliamperes (mA) | During uptitration of the amplitude (entire process takes 3-4 minutes) |
| Side effect threshold (mA) | Amplitude needed to elicit non-transient side effects, expressed in milliamperes (mA) | During uptitration of the amplitude (entire process takes 3-4 minutes) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZ Leuven | Leuven | 3000 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36404213 | Derived | Boogers A, Peeters J, Van Bogaert T, De Vloo P, Vandenberghe W, Nuttin B, Mc Laughlin M. Interphase Gaps in Symmetric Biphasic Pulses Reduce the Therapeutic Window in Ventral Intermediate Nucleus of the Thalamus-Deep Brain Stimulation for Essential Tremor. Neuromodulation. 2023 Dec;26(8):1699-1704. doi: 10.1016/j.neurom.2022.09.012. Epub 2022 Nov 18. |
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| ID | Term |
|---|---|
| D020329 | Essential Tremor |
| ID | Term |
|---|---|
| D009069 | Movement Disorders |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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The patient will be allocated to the both arms in a cross-over design (no interphase gap and interphase gaps of different lenghts). The order of the pulses will be delivered in a random order, and with a double-blind design. Of all pulses, the therapeutic window will be assessed acutely (3 times per pulse shape).
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