Ignite Creation Date:
2024-05-06 @ 1:23 PM
Last Modification Date:
2024-10-26 @ 1:13 PM
Study NCT ID:
NCT04009928
Status:
RECRUITING
Last Update Posted:
2023-12-05
First Post:
2019-07-03
Brief Title:
Deep Brain Stimulation for Treatment Resistant Depression
Sponsor:
Sunnybrook Health Sciences Centre
Organization:
Sunnybrook Health Sciences Centre
Study Overview
Official Title:
Deep Brain Stimulation of the Medial Forebrain Bundle and Subcallosal Cingulate for the Treatment of Treatment Resistant Depression
Status:
RECRUITING
Status Verified Date:
2023-12
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:
None
Brief Summary:
Treatment resistant depression TRD is a major global health concern and there is a crucial need to develop novel effective treatments
The medial forebrain bundle MFB is a recently described DBS target with reported rapid onset of antidepressant effects A recent small randomized trial reported a 100 response rate The subcallosal cingulate cortex SCC is the most commonly used target in DBS for depression
Herein the investigators will conduct a sham-controlled randomized trial of DBS to the MFB or SCC for TRD
The medial forebrain bundle MFB is a recently described DBS target with reported rapid onset of antidepressant effects A recent small randomized trial reported a 100 response rate The subcallosal cingulate cortex SCC is the most commonly used target in DBS for depression
Herein the investigators will conduct a sham-controlled randomized trial of DBS to the MFB or SCC for TRD
Detailed Description:
Eight patients with TRD will be treated with DBS to the MFB At approximately 2 weeks postoperartively stimulation will be initiated in all patients Voltage and contact position will be altered initially looking for optimal and stabilized responses in depressive symptoms while trying to minimize any side effects
Following this 6 month open-label optimization phase patients will be then undergo randomization to receive 2 weeks of stimulation followed by 2 weeks of sham stimulation or vice versa These 2 week phases will be separated by a 1 week washout period Depressive symptoms will be evaluated at the end of each 2 week phase then patients will resume open-label stimiulation
Following this 6 month open-label optimization phase patients will be then undergo randomization to receive 2 weeks of stimulation followed by 2 weeks of sham stimulation or vice versa These 2 week phases will be separated by a 1 week washout period Depressive symptoms will be evaluated at the end of each 2 week phase then patients will resume open-label stimiulation
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