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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 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.

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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.

Interventions

  • DEVICE Abbott Laboratories Infinity™ implantable deep brain stimulation system

Study Locations (1)

Texas

  • UT Southwestern Medical Center - Dallas

Trial Details

FieldValue
Enrollment Target 12 participants
Start Date 2022-10-28
Est. Completion 2027-07
Phase NA

Sponsor

Nader Pouratian

3 total trials

What the Registry Record Tells You About NCT03952962

The ClinicalTrials.gov registry entry for NCT03952962 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 374-participant average among 54 other Treatment-Resistant Depression trials with a reported enrollment target (97% lower). The listed sponsor is Nader Pouratian, which has 3 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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