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ID
Source
Brief title
Health condition
Dystonia
Sponsors and support
Intervention
Outcome measures
Primary outcome
o MEP thresholds, obtained during the surgery
o Distances in mm from DBS lead to IC, measured on intraoperative CT
Secondary outcome
None
Background summary
Rationale:
A well-known and serious side-effect of deep brain stimulation (DBS) is activation of the motor-tract (corticospinal tract), anatomically located in the internal capsule. To ensure a safe distance between the DBS lead and the motor-tract, intraoperative testing in an awake setting is utilized. Since awake surgery is often impossible for dystonic patients, an objective measure to ensure safe distance to the motor-tract during general anesthesia is lacking.
Objective:
To determine the correlation between the threshold of the motor evoked potential (MEP) stimulated via the DBS-lead and the (safe) distance between the DBS-lead and the internal capsule (IC).
Study design:
An intraoperative stimulation protocol is applied to determine the MEP-threshold of contralateral muscles by stimulation via the DBS-lead in dystonic patients under general anesthesia. Since the IC and DBS-lead both are depicted on postoperative imaging, the MEP-threshold is compared with the shortest distance between these structures.
Study population:
Adult dystonic patients undergoing DBS of the Globus Pallidus internus (GPi).
Main study parameters/endpoints:
The primary endpoints of the study are the threshold of the MEP during surgery and the distance between the DBS lead and the IC on intraoperative imaging.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
The NIM-Eclipse intraoperative neuromonitoring system (Medtronic) will be attached to the DBS-leads, which is considered off-label use of this system. Subjects are not submitted to additional risks.
If there is a the correlation between the MEP-threshold and the distance from the DBS lead to the IC, the NIM-Eclipse system can serve as an intraoperative tool to ensure safe distance between these two structures.
Study objective
There is a correlation between the threshold to elicit a MEP by stimulating the DBS lead and the distance between the DBS lead and the internal capsule
Study design
During surgery
Inclusion criteria
Dystonia patients undergoing bilateral GPi-DBS surgery under general anaesthesia in the University Medical Center Groningen
Exclusion criteria
None
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL9557 |
| Other | METC UMCG : METCXXX |