Tardive Dystonia Clinical Trial
Official title:
Validation of an Electrode Internal Globus Pallidum Deep Brain Stimulation Lead Implantation for Treatment of Dystonia
The main objective of the trial is to study the technical feasibility of the implantation of a new electrode Monocontact deep brain stimulation electrode in dystonia.
Deep brain stimulation (DBS) is a validated therapy for treating dystonia and other movement
disorders. The main therapeutical target used for treating dystonic syndromes is the internal
globus pallidum (GPi). Given the morphology and the topography of this nucleus and, based on
the experience of an efficient therapy by using only one or two contacts out of the available
four contacts of the standard DBS lead, we designed two new electrodes, one one
contact-electrode and one two contact-electrodes, with the aim to limit side effects related
to internal globus pallidum DBS and to provide a more homogeneous electric field around the
electrode within the GPi and maintaining the same therapeutical outcome.
The main objective of the trial is to study the technical feasibility of the implantation of
a new one contact-electrode (Monopolar DBS Lead Model 09064-40cm) for treating isolated
generalized/segmental dystonia or tardive dystonia.
The second main objective of the study is to assess the safety of the implantation of the new
device.
The secondary objective is to explore the therapeutical effect of DBS using the new
monocontact electrode and to study the electrical field generated around the monocontact
electrode within the GPi.
The study is prospective and patients are recruited from a Tertiary Movement Disorders
Clinic. Seven subjects will be recruited for the study.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT02524886 -
Deep Brain Stimulation for Patients With Tardive Dyskinesia and or Dystonia
|
N/A | |
| Completed |
NCT01921270 -
Dysport for the Treatment of OMD
|
Phase 1/Phase 2 |