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Procedure

DBS for Depression

Phase 1

Recruiting

Led By Albert J Fenoy, MD

Research Sponsored by Northwell Health

Eligibility Criteria Checklist

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

Must have

Age 22 - 70 years

Major Depression Disorder (MDD) diagnosed by Structured Clinical Interview for DSM-V (SCID I/DSM-V)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

Study Summary

This trial will test if deep brain stimulation can help treat treatment resistant depression and improve overall well-being. Participants will have a device implanted and monitored for 5 years to study its effects.

Who is the study for?

This trial is for adults aged 22-70 with severe, treatment-resistant depression. They must have tried multiple medications, psychotherapy, and possibly ECT without success. Participants need to be stable on their current meds and willing to be monitored over 5 years. Exclusions include those with psychosis history, unstable living situations, certain medical conditions or contraindications for surgery.Check my eligibility

What is being tested?

Researchers are testing a Medtronic SenSight Directional DBS lead device implanted in participants to treat resistant depression. Over five years, the device's effectiveness will be assessed by turning it off at random times without participants' knowledge and comparing their questionnaire scores during these periods.See study design

What are the potential side effects?

Potential side effects may include discomfort from the implantation procedure of the DBS device, headache or infection at the surgical site. There might also be risks related to hardware malfunction or adverse changes in mood or behavior due to stimulation.

Eligibility Criteria

Inclusion Criteria

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

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I am between 22 and 70 years old.

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I have been diagnosed with Major Depression Disorder.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Montgomery-Asberg Depression Rating Scale (MADRS)

Secondary outcome measures

Clinical Global Impressions (CGI) rated severity

Global Assessment of Functioning (GAF) rated functional impairment

Measuring MADRS during discontinuation cross over weeks

Trial Design

2Treatment groups

Experimental Treatment

Group I: Discontinuation Phase Group 2Experimental Treatment1 Intervention

Patients will be randomized into two groups for crossover treatment analysis of different parameter settings for six weeks.

Group II: Discontinuation Phase Group 1Experimental Treatment1 Intervention

Patients will be randomized into two groups for crossover treatment analysis of different parameter settings for six weeks.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

MedtronicIndustry Sponsor

606 Previous Clinical Trials

828,645 Total Patients Enrolled

Northwell HealthLead Sponsor

458 Previous Clinical Trials

470,913 Total Patients Enrolled

Albert J Fenoy, MDPrincipal InvestigatorNorthwell Health

2 Previous Clinical Trials

122 Total Patients Enrolled

Frequently Asked Questions

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

Are there any age limits to entering this research project?

"The minimum age requirement for this experiment is 22 years old, while the maximum permissible age to join is 70."

Answered by AI

Is Discontinuation Phase Group 1 a safe protocol for participants?

"Our evaluation committee at Power rated the safety of Discontinuation Phase Group 1 a 1 due to its limited clinical data proving efficacy and ensuring patient security."

Answered by AI

Could I potentially participate in this medical experimentation?

"To enroll in this medical trial, the patient must be between 22 and 70 years of age while being clinically diagnosed with major depressive disorder. The research team is seeking to recruit 20 patients for this clinical investigation."

Answered by AI

How many people are currently involved in this medical study?

"Affirmative. Clinicaltrials.gov shows that this investigation, which was originally publicized on October 18th 2023, is currently seeking participants. Approximately 20 people need to be enlisted from 1 medical site."

Answered by AI

Is enrollment still open for this experiment?

"The current status of this medical research as indicated on clinicaltrials.gov is actively recruiting participants. This experiment was initially posted and subsequently edited both in October, 2023."

Answered by AI

Who else is applying?

What site did they apply to?

Zucker Hillside Hospital

What portion of applicants met pre-screening criteria?

Met criteria

Why did patients apply to this trial?

I have tired practically every single antidepressant drug/combination, yet my depression is reoccurring. Over the past 2 years I have been continuously depressed despite changes in medications, therapy, transcrainal simulation, changes in MD, etc.

PatientReceived 2+ prior treatments

Recent research and studies

clinicaltrials.govStudy

DBS for Depression

2023. "DBS for Depression". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06096207.

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