Ignite Creation Date:
2024-05-06 @ 2:39 AM
Last Modification Date:
2024-10-26 @ 11:21 AM
Study NCT ID:
NCT02095600
Status:
COMPLETED
Last Update Posted:
2019-03-20
First Post:
2014-03-21
Brief Title:
Radiosurgery for Drug Resistant Invalidating Tremor
Sponsor:
Fondazione IRCCS Istituto Neurologico Carlo Besta
Organization:
Fondazione IRCCS Istituto Neurologico Carlo Besta
Study Overview
Official Title:
Deep Brain Stimulation and Frameless Stereotactic Radiosurgery in the Treatment of Drug Resistant Invalidating Tremor
Status:
COMPLETED
Status Verified Date:
2019-03
Last Known Status:
None
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:
DB-SRS
Brief Summary:
Stereotactic lesioning of thalamus and basal ganglia for treatment of tremor is a well-known procedure which prior to the introduction of deep brain stimulation or DBS was usually achieved using stereotactic surgical procedures
Radiosurgery of invisible targets to treat movement disorders and intractable pain are still the domain of frame-based procedures due to the need of a solid reference system registered to the anterior commissure-posterior commissure AC-PC line which allows the use of stereotactic atlases
In this study we want to utilize a mathematical method that uses atlas-derived stereotactic coordinates to perform frameless images-guided radiosurgery of such functional targets Particularly the aim of the present study is to investigate both the efficacy and the safety of the methodology to treat upper limb and hand tremor in elderly or in patients which are not ot susceptible of surgical procedures For these reasons a dose escalation prospective trial have been designed
Radiosurgery of invisible targets to treat movement disorders and intractable pain are still the domain of frame-based procedures due to the need of a solid reference system registered to the anterior commissure-posterior commissure AC-PC line which allows the use of stereotactic atlases
In this study we want to utilize a mathematical method that uses atlas-derived stereotactic coordinates to perform frameless images-guided radiosurgery of such functional targets Particularly the aim of the present study is to investigate both the efficacy and the safety of the methodology to treat upper limb and hand tremor in elderly or in patients which are not ot susceptible of surgical procedures For these reasons a dose escalation prospective trial have been designed
Detailed Description:
None
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