Ignite Creation Date:
2024-05-06 @ 10:25 AM
Last Modification Date:
2024-10-26 @ 12:30 PM
Study NCT ID:
NCT03254017
Status:
TERMINATED
Last Update Posted:
2019-11-29
First Post:
2017-08-16
Brief Title:
Remotely Programmed Deep Brain Stimulation of the Bilateral Habenula for Treatment- Resistant Major Depression An Open Label Pilot Trial
Sponsor:
Ruijin Hospital
Organization:
Ruijin Hospital
Study Overview
Official Title:
Remotely Programmed Deep Brain Stimulation of the Bilateral Habenula for Treatment- Resistant Major Depression An Open Label Pilot Trial
Status:
TERMINATED
Status Verified Date:
2019-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
logistics reasons
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The habenulaHb is an epithalamic structure located at the center of the dorsal diencephalic conduction system a pathway involved in linking forebrain to midbrain regions An increasing number of studies indicates that that overactivity in the lateral habelunaLHb is present during depressed states where it could drive the changes in midbrain activity linked to depression Deep brain stimulationDBS of the major afferent bundle ie stria medullaris thalami of the LHb can treat treatment-resistant major depressionTRD There is no clinical case of directly stimulating habeluna for treatment TRD This research will investigate effectiveness bilateral DBS to habenula for patients with TRD
Programming is a crucial aspect of DBS which directly influences its therapeutic efficacy Researchers need to ascertain optimum stimulation parameters to help patients achieve optimal control of clinical symptoms Remote programming of DBS can markedly improve patient convenience minimize risk of infection and total treatment time and lead to an overall benefit for doctors and patients alike This research will also investigate safety and benefit of remote programming of DBS
Programming is a crucial aspect of DBS which directly influences its therapeutic efficacy Researchers need to ascertain optimum stimulation parameters to help patients achieve optimal control of clinical symptoms Remote programming of DBS can markedly improve patient convenience minimize risk of infection and total treatment time and lead to an overall benefit for doctors and patients alike This research will also investigate safety and benefit of remote programming of DBS
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None