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NCT03952962 · ClinicalTrials.gov registry record · NA
Tractography Guided Subcallosal Cingulate Deep Brain Stimulation for Treatment Resistant Depression
A NA study of Treatment-Resistant Depression and Undergoing Deep Brain Stimulation (DBS) Surgery, sponsored by Nader Pouratian.
- Recruiting
- Registry status
- NA
- Development phase
- 12
- Enrollment target
- 1
- Study location
NCT03952962: Recruiting NA study of Treatment-Resistant Depression and Undergoing Deep Brain Stimulation (DBS) Surgery, sponsored by Nader Pouratian.
NCT03952962 is a NA study of Treatment-Resistant Depression and Undergoing Deep Brain Stimulation (DBS) Surgery that is actively recruiting participants, run by Nader Pouratian. The registered enrollment target is 12 participants, below the 374-participant average among 54 other Treatment-Resistant Depression trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03952962, a NA study of Treatment-Resistant Depression and Undergoing Deep Brain Stimulation (DBS) Surgery, is actively recruiting participants, sponsored by Nader Pouratian.
- RECRUITING
- Registry status
- NA
- Development phase
- 12 participants
- Enrollment target
- 1
- Study location
Study Summary
Treatment resistant depression remains a major problem for individuals and society. Surgical procedures may provide relief for some of these patients. The most frequently considered surgical approach is deep brain stimulation (DBS) of a part of the brain called the subcallosal cingulate region. However, the effectiveness and safety is not well established. The investigators will use a novel approach using advanced imaging technique (magnetic resonance tractography) to evaluate the feasibility and safety of this surgical approach. An innovative method for the definition of DBS target will be applied that redefines the concept of targeting as one of targeting a symptomatic network rather than a structural brain region using subject-based brain anatomy to define the target location. The correlation between imaging findings at baseline with the mood score changes at different time points of the study will be investigated.
Primary Outcome
The primary endpoint will be defined as at least a 40% reduction in the Montgomery and Asberg Depression Rating Scale (MADRS) that measures depression severity. The MADRS scores range from 0 to 60, where increased values indicate more severe depression. There are 10 questions that each yield a score of 0-6 that are then summed for a total score.
Conditions Studied
Interventions
- DEVICE Abbott Laboratories Infinity™ implantable deep brain stimulation system
Study Locations (1)
Texas
- UT Southwestern Medical Center - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2022-10-28 |
| Est. Completion | 2027-07 |
| Phase | NA |
What NCT03952962 shows while recruiting
NCT03952962 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 374-participant average among 54 other Treatment-Resistant Depression trials with a reported enrollment target (97% lower).
The record links to 2 conditions, with Treatment-Resistant Depression appearing as the primary indexed condition, and to 1 intervention - of which Abbott Laboratories Infinity™ implantable deep brain stimulation system is the first listed.
NCT03952962 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT03952962 about?
NCT03952962 is a clinical study titled "Tractography Guided Subcallosal Cingulate Deep Brain Stimulation for Treatment Resistant Depression". Treatment resistant depression remains a major problem for individuals and society. Surgical procedures may provide relief for some of these patients. The most frequently considered surgical approach is deep brain stimulation (DBS) of a part of the brain called the subcallosal cingulate region. Howe...
What is the current status of trial NCT03952962?
This trial is currently recruiting. It is a NA study. The enrollment target is 12 participants. The study started on 2022-10-28. Estimated completion is 2027-07.
What conditions does trial NCT03952962 study?
This clinical trial studies the following conditions: Treatment-Resistant Depression, Undergoing Deep Brain Stimulation (DBS) Surgery.
What interventions are being tested in trial NCT03952962?
The interventions under investigation include: Abbott Laboratories Infinity™ implantable deep brain stimulation system (DEVICE).
Who is sponsoring clinical trial NCT03952962?
This trial is sponsored by Nader Pouratian, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03952962 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Treatment-Resistant Depression
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03952962's enrollment target sits among peer trials
12 47th of 54 higher than 7 of 54 other Treatment-Resistant Depression trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Treatment-Resistant Depression trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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