PACE Trial

Personalized
Adaptive
Cortical
Electro-Stimulation

Clinical Trial Research Study for Depression

Learn More

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About the Trial

This research study is designed to test the effectiveness of electrical stimulation on the surface of the brain to treat depressive symptoms. The electrical stimulation specifically targets the outer layer of both sides of the brain right behind the forehead and is known as personalized adaptive cortical electro-stimulation (PACE).

Screening Process

Enrolled participants go through comprehensive screening, including MRI, evaluation of depressive symptoms and treatments, and medical evaluations.

Surgical Procedure

Qualified participants undergo neurosurgery to place electric leads on the surface of the brain, connected to two pacemaker-like devices beneath the collarbone.

Study Duration

19 visits in the first year for symptom review and device optimization, followed by 4 visits in the second year to track long-term outcomes. Some visits available via Zoom.

Eligibility Criteria

Participants MUST:

  • Be 22 to 70 years old
  • Be under the care of psychiatrist
  • Have a diagnosis of a chronic depressive episode that has not had an adequate response to four or more adequate antidepressant treatments
  • Have tried ECT or refused to undergo ECT if it was clinically indicated
  • Be able to consent to the study and complete the evaluations needed for this study, including the MRI and EEG

Participants MUST NOT:

  • Have medical or mental health conditions that pose an unacceptable risk for the procedure or use of the device
  • Be unable to have a full body MRI
  • Be acutely suicidal OR have had a suicide attempt in the past 12 months OR be likely to attempt suicide in the next 6 months
  • Be pregnant
  • Have DBS (Deep Brain Stimulation) or VNS (Vagus Nerve Stimulation) (active in the last 6 months)

Find Out More

To learn more about the PACE Trial or to refer patients for the study, please contact the trial team with the form below or by emailing PLACEHOLDER@EMAIL.com or calling 1-234-567-8910