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Deep Brain Stimulation

Deep Brain Stimulation for Treatment-Resistant Depression

N/A

Waitlist Available

Led By Christopher Rozell, PhD

Research Sponsored by Emory University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Current Major Depressive Episode (MDE), either Major Depressive Disorder single episode or recurrent type

Current depressive episode of at least two years duration or a history of more than 4 lifetime depressive episodes

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline; recovery period with stimulation off: 24 hours post-operative, week 4; stimulation phase: as needed up to week 30; naturalistic follow up: as needed for up to 10 years

Awards & highlights

Study Summary

This trial is investigating a potential new treatment for people with treatment-resistant depression, which is a form of depression that does not respond well to conventional treatments. The new treatment involves placing electrodes in a specific region of the brain and stimulating it with electricity. The goal of the trial is to use a new device to study the electrical activity in the brain around the site of stimulation, in order to understand the changes that occur when the treatment is given.

Who is the study for?

This trial is for adults aged 25-70 with Treatment Resistant Depression (TRD), who've had a depressive episode lasting at least two years or four lifetime episodes. Participants must score ≥20 on the HDRS-17 scale, have tried and not responded to four different antidepressant treatments including ECT, and be willing to relocate to Atlanta for 8-10 months.Check my eligibility

What is being tested?

The study tests the Medtronic Activa PC+S System's effect on brain activity in TRD patients. It aims to understand how Deep Brain Stimulation (DBS) alters neural networks associated with depression by measuring brain signals before and during stimulation.See study design

What are the potential side effects?

While specific side effects of DBS are not listed here, common ones include headache, seizure, confusion, difficulty concentrating, mood changes, and hardware complications like infection or device malfunction.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am currently experiencing a major depressive episode.

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I have been depressed for at least two years or had more than 4 depressive episodes.

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I have tried ECT before and it didn't work or caused side effects.

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I am on a steady dose of antidepressant medication.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline; recovery period with stimulation off: 24 hours post-operative, week 4; stimulation phase: as needed up to week 30; naturalistic follow up: as needed for up to 10 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline; recovery period with stimulation off: 24 hours post-operative, week 4; stimulation phase: as needed up to week 30; naturalistic follow up: as needed for up to 10 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline; recovery period with stimulation off: 24 hours post-operative, week 4; stimulation phase: as needed up to week 30; naturalistic follow up: as needed for up to 10 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Hamilton Depression Rating Scale-17 Score

Changes in Activa PC+S Local Field Potential (LFP) Recordings

Secondary outcome measures

Change in 9-item Patient Health Questionnaire (PHQ-9) Score

Change in Beck Anxiety Inventory (BAI) Score

Change in Beck Depression Inventory (BDI-2) Score

+21 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: DBS for Treatment Resistant DepressionExperimental Treatment1 Intervention

DBS for TRD: Exploration of LFP with the Medtronic Activa PC+S "Brain Radio" system

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Emory UniversityLead Sponsor

1,636 Previous Clinical Trials

2,560,563 Total Patients Enrolled

The Dana FoundationOTHER

17 Previous Clinical Trials

974 Total Patients Enrolled

National Institute of Neurological Disorders and Stroke (NINDS)NIH

1,339 Previous Clinical Trials

649,380 Total Patients Enrolled

Media Library

Medtronic Activa PC+S System (Deep Brain Stimulation) Clinical Trial Eligibility Overview. Trial Name: NCT01984710 — N/A

Major Depressive Disorder Research Study Groups: DBS for Treatment Resistant Depression

Major Depressive Disorder Clinical Trial 2023: Medtronic Activa PC+S System Highlights & Side Effects. Trial Name: NCT01984710 — N/A

Medtronic Activa PC+S System (Deep Brain Stimulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01984710 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is admission to this trial still available for applicants?

"The data hosted on clinicaltrials.gov indicates that this research project is not presently recruiting patients, which was last updated in August 2021. Although no longer actively searching for trial participants, there are 1297 other trials currently seeking volunteers."

Answered by AI

Who meets the criteria for enrollment in this medical trial?

"This clinical trial is seeking 10 individuals with melancholia aged 18 and 70. To be eligible, the patient must have endured a minimum of four different antidepressants treatments without response or intolerance to an adequate course of ECT during any episode. The prospective study participant should also agree to relocate near Atlanta for 8-10 months plus return regularly for assessments and possess a written release allowing investigators access their outpatient psychiatrist records. Furthermore, they are required to fall within the age range 25-70 years old and meet either criteria: having experienced current depressive episode lasting two years or more than 4 lifetime depressive episodes."

Answered by AI

Does the patient eligibility criteria of this research encompass those older than 45 years?

"This study is open to patients between 18 and 70 years old. Individuals under the age of 18 are included in 192 other trials, while individuals over 65 can find participation opportunities in 969 different clinical studies."

Answered by AI