Ignite Creation Date:
2024-05-06 @ 7:12 AM
Last Modification Date:
2024-10-26 @ 11:46 AM
Study NCT ID:
NCT02491554
Status:
UNKNOWN
Last Update Posted:
2021-07-28
First Post:
2015-06-30
Brief Title:
Deep braIn Stimulation for Tremor TractographIC Versus Traditional
Sponsor:
University Hospital Freiburg
Organization:
University Hospital Freiburg
Study Overview
Official Title:
Deep braIn Stimulation for Tremor TractographIC Versus Traditional
Status:
UNKNOWN
Status Verified Date:
2021-07
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DISTINCT
Brief Summary:
This is a monocentric randomized controlled 2 arms interventional observer-blinded feasibility trial
Patients suffering from essential tremor ET will be treated with Deep Brain Stimulation DBS For the implantation of the DBS electrodes and the DBS system Activa INS Medtronic patients will randomized either to conventional stereotactic surgery of thalamicsubthalamic region with short anesthesia or to MR-tractography guided stereotactic surgery with target point of the dentato-rubro-thalamic bundle DRT in general anesthesia
Patients will visit the study center at screening baselineneurosurgery six and twelve months after neurosurgery
Patients suffering from essential tremor ET will be treated with Deep Brain Stimulation DBS For the implantation of the DBS electrodes and the DBS system Activa INS Medtronic patients will randomized either to conventional stereotactic surgery of thalamicsubthalamic region with short anesthesia or to MR-tractography guided stereotactic surgery with target point of the dentato-rubro-thalamic bundle DRT in general anesthesia
Patients will visit the study center at screening baselineneurosurgery six and twelve months after neurosurgery
Detailed Description:
In this monocentric randomized controlled 2 arms interventional observer-blinded feasibility trial patients suffering from therapy resistant essential tremor ET will be treated with Deep Brain Stimulation DBS
After screening eg obtaining informed consent assessment of inclusionexclusion criteria etc patients will be randomized to one of the following groups
Group 1 conventional
Conventional AC-PC based DBS implantation in the thalamicsubthalamic region Vim-cZI starting as awake surgery with a brief general anesthesia for stimulator implantation at the end of surgery
Group 2 tractographic
Magnetic resonance MR-tractography guided DBS implantation in the dentato-rubro-thalamic bundle DRT in general anesthesia
At the baselineneurosurgery visit Quality of Life QoL and other parameters will assessed Medtronics Activa INS DBS will be implanted according to randomization DBS will be started approximately one month after surgery and will be applied as per routine
Patients will have their routine visits For this trial data of the routine visits six and twelve months after neurosurgery will be collected
Patients receive DBS after the end of the trial according to local standards
After screening eg obtaining informed consent assessment of inclusionexclusion criteria etc patients will be randomized to one of the following groups
Group 1 conventional
Conventional AC-PC based DBS implantation in the thalamicsubthalamic region Vim-cZI starting as awake surgery with a brief general anesthesia for stimulator implantation at the end of surgery
Group 2 tractographic
Magnetic resonance MR-tractography guided DBS implantation in the dentato-rubro-thalamic bundle DRT in general anesthesia
At the baselineneurosurgery visit Quality of Life QoL and other parameters will assessed Medtronics Activa INS DBS will be implanted according to randomization DBS will be started approximately one month after surgery and will be applied as per routine
Patients will have their routine visits For this trial data of the routine visits six and twelve months after neurosurgery will be collected
Patients receive DBS after the end of the trial according to local standards
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| DRKS00008913 | REGISTRY | German Clinical Trial Register | None |