Trial Search Results

Adaptive Design Study of NEST sTMS in Subjects With Major Depressive Disorder

This is a double-blind, sham controlled, multi-center study to confirm the safety and efficacy of synchronized transcranial magnetic stimulation (sTMS) for the treatment of patients currently experiencing an episode of depression who have failed to respond to at least one (1) antidepressant medication. Patients will be randomly assigned to either active or sham therapy and will undergo daily treatments for a period of time. Following completion of blinded treatments, patients may be eligible for a course of open label treatments.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

NeoSync, Inc.

Stanford Investigator(s):

Intervention(s):

  • Device: Synchronized Transcranial Magnetic Stimulation (sTMS)
  • Device: Sham Stimulation

Phase:

N/A

Eligibility


Inclusion Criteria:

   - Current episode of Major Depressive Disorder

   - Inadequate response to at least one antidepressant medication in the current episode
   (Treatment Resistant Depression)

   - Investigator able to identify IAF using EEG

   - Willingness and ability to adhere to treatment schedule (5 treatments per week for six
   weeks)

Exclusion Criteria:

   - Unable to unwilling to give informed consent

   - Diagnosed with excluded conditions or treatment histories

   - Currently hospitalized due to severity of depression symptoms

   - Use of prohibited medications (as defined by protocol) within specified time frame of
   randomization

   - Use of certain cardiac devices

   - Use of certain intracranial devices

   - Currently pregnant or unwilling to practice acceptable means of birth control, and
   women who are breastfeeding

Ages Eligible for Study

22 Years - 65 Years

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Olivia Jang
650-497-1890
Recruiting