Is NCT04124341 recruiting in Minneapolis, MN?

Yes, NCT04124341 is currently recruiting participants at its Minneapolis, MN location. This treatment resistant depression clinical trial is actively enrolling qualified participants.

Is participation in this Minneapolis clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Treatment Resistant Depression Clinical Trial in Minneapolis, MN

Q: How do I join the treatment resistant depression clinical trial in Minneapolis?

To join this clinical trial in Minneapolis, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

About This Treatment Resistant Depression Study in Minneapolis

This research study is designed to test if electrical stimulation of the surface of the brain in the frontal region will help treat depressive symptoms. Participants receive intermittent electrical stimulation to the brain, which involves surgically placing electric leads in between the tough fibrous membrane covering the surface of the brain and the surface of the brain itself. This type of stimulation is referred to as bilateral subdural prefrontal cortical stimulation (PCS) because it will specifically target the outer layer of the brain at the midline, right behind the forehead. It uses a pacemaker-like device, the Proclaim Elite SCS System (non-rechargeable) or the Eterna SCS System (rechargeable), both by Abbott Laboratories for stimulation. Although the U.S. Food and Drug Administration (FDA) has approved the Proclaim Elite SCS system for brain stimulation for patients with chronic pain and muscular diseases, such as Parkinson's, its use is still investigational, and the surgery is still experimental for patients who have depression.

Sponsor: University of Minnesota

Who Can Participate

Inclusion Criteria

Participant must be able to provide written informed consent.

Participant has a diagnosis of chronic (greater than or equal to 2 years) depressive episode as defined by DSM V criteria

Participant has not had an adequate response to four or more adequate antidepressant treatments from at least two different antidepressant treatment categories in the current depressive episode according to the Antidepressant Treatment History Form (ATHF)

Participant must have had ECT (Electroconvulsive Therapy) or refused to undergo ECT if clinically indicated to them

Participant must have HRSD greater than or equal to 20 at study entry

Participant must be able to complete the evaluations needed for this study including the functional imaging scans and the EEG Bayesian optimization sessions

Participant must be under the care of a licensed psychiatrist, undergoing regular care evaluations, and inform study team of any change to care team during study participation

Participant must agree to allow all forms of communication between investigators and study staff and any health care provider (current or having provided service within two years of enrollment)

Participant must provide name and contact information for at least two people greater than or equal to 22 in age who reside within a 30 minute drive of the participant's residents and whom staff may contact as necessary during study participation

Participant must be enrolled in a Medicare program

Exclusion Criteria

The PCS would (in the investigator's judgment) pose an unacceptable surgical or medical risk for the participant

Participant is unable to undergo required full body magnetic resonance imaging (MRI) during the clinical study

Participant is judged by the investigator to be acutely suicidal (e.g. within the 30 days prior to the PCS implant the participant has made a suicide attempt or gesture or has made specific plans or preparation to commit suicide or scores 21 or higher on the MSSI)

In addition to the acute suicidal risks mentioned above, participant meets any of the following:

Has made a suicide attempt within the previous 12 months that required medical treatment

Has made greater than or equal to two suicide attempts in the past 12 months

Has a clear-cut plan for suicide that states that she/he cannot guarantee that she/he will call her/his regular psychiatrist or the Investigator if the impulse to implement the plan becomes substantial during the study

Is likely to attempt suicide within the next six months, in the Investigator's opinion

Participant has a history of schizophrenia, schizoaffective disorder, or other psychotic disorder, or a current major depressive episode that includes psychotic features (commonly referred to as psychotic depression) according to the DSM V criteria

Participant with a diagnosis of dementia with a Mini-Mental State Exam (MMSE) less than or equal to 23

Participant with a positive urine pregnancy test

Participant with a positive urine drug screen

Participant with DBS (Deep Brain Stimulator)

Participant with VNS (Vagus Nerve Stimulator) if the device was active in the last 6 months prior to study enrollment

Participant with history of seizures

Participant determined by surgical safety committee to have cerebral atrophy, neurodegenerative or neurovascular disease due to age or medical condition that would prohibit optimal surgical safety, per clinical MRI

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Minneapolis?

Yes, this clinical trial (NCT04124341) has an active research site in Minneapolis, MN that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Treatment Resistant Depression Treatment Options in Minneapolis, MN

If you're searching for treatment resistant depression treatment options in Minneapolis, MN, this clinical trial (NCT04124341) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Minneapolis research site is actively enrolling participants for this clinical trial. You'll receive care from experienced treatment resistant depression specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all treatment resistant depression clinical trials near you to find additional studies recruiting in your area.

Treatment Resistant Depression Clinical Trial in Minneapolis, MN

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