Long Term Follow-up of Deep Brain Stimulation for Treatment-Resistant Depression

NCT03360942 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2024-12-12

Study results available
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Summary

The long term follow up of a pilot study in which the investigators proposed to test whether high frequency stimulation of the subcallosal cingulate (SCC) is a safe and efficacious antidepressant treatment in five TRD patients, to compare the effects of left-sided vs. right-sided stimulation, and to investigate potential mechanisms of action of this intervention. Importantly, this study will be used to assess the need for and assist in planning a larger, more definitive trial of SCC Deep Brain Stimulation (DBS) for treatment-resistant depression (TRD).

Conditions

Interventions

DEVICE

SCC DBS

Deep Brain Stimulator

Sponsors & Collaborators

  • Dartmouth-Hitchcock Medical Center

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-18
Primary Completion
2022-09-30
Completion
2022-09-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03360942 on ClinicalTrials.gov