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

NCT03288714 | Completed Results DMC FDA Device

• 1 other identifier: NND-3002
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 14

Brief Summary

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.

Conditions

Depressive Disorder; Depression; Depressive Disorder, Major; Depressive Episode; Major Depressive Disorder

Keywords

Transcranial Magnetic Stimulation; TMS; sTMS

Outcome Measures

Primary Outcomes (1)

• Incidence of Clinical Response (Reduction of At Least 50% in Baseline HAMD-17 Score) in Per-Protocol Population

  Number of participants at the end of each treatment week who saw a reduction of at least 50% in baseline Hamilton Depression Rating Scale (HAMD-17) scores from baseline to week 6, compared between the active treatment and sham-controlled groups. The Hamilton Depression Rating Scale (HAMD-17) system asks 17 questions to rank subject on a scale ranges between 0-52, with higher numbers indicating more severe symptoms. 0-7 is generally accepted to be within the normal range (or in remission), while a score of 20 or higher indicates moderate to severe depression.

  Baseline (Day 0) to End of Weeks 1, 2, 3, 4, 5, 6

Secondary Outcomes (5)

• Mean Change (SD) in HAMD-17 Scores From Baseline to End of Treatment

  Baseline (Day 0) and End of Weeks 1, 2, 3, 4, 5, 6

• Mean Change (SD) in MADRS Scores From Baseline to End of Treatment in the Per-Protocol Population

  Baseline (Day 0) and End of Weeks 1, 2, 3, 4, 5, 6

• Responder Analysis: Mean Change (SD) in HAMD-17 Scores From Baseline to End of Treatment in Per-Protocol Patients With Individual Alpha Frequency Greater Than 9.8 Hz

  Baseline (Day 0) and End of Weeks 1, 2, 3, 4, 5, 6

• Mean Change (SD) in HAMD-17 Scores From Baseline to Week 6 of Open-Label Treatments

  Baseline (sTMS Week 6/Sham Baseline) and End of Weeks 7, 8, 9, 10, 11, 12

• Incidence of Clinical Response (Reduction of At Least 50% in Baseline HAMD-17 Score) in Open-Label Per-Protocol Population

  Baseline (sTMS Week 6/Sham Baseline) and End of Weeks 7, 8, 9, 10, 11, 12

Study Arms (2)

Active sTMS

EXPERIMENTAL

Synchronized Transcranial Magnetic Stimulation (sTMS) treatments to be administered using an active device 5 times per week for six treatment weeks.

Device: Synchronized Transcranial Magnetic Stimulation (sTMS)

Sham Stimulation

SHAM COMPARATOR

Sham treatments to be administered using a sham device 5 times per week for six treatment weeks.

Device: Sham Stimulation

Interventions

Synchronized Transcranial Magnetic Stimulation (sTMS) DEVICE

sTMS delivers brain stimulation via a continuous magnetic field created by the device and set to the individual patient's intrinsic alpha frequency (IAF).

Active sTMS

Sham Stimulation DEVICE

Sham stimulation is designed to look, sound and feel like the investigational device, but does not deliver magnetic stimulation to the brain.

Sham Stimulation

Eligibility Criteria

• Age: 22 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Wave Neuroscience: lead

Study Sites (14)

Kadima Neuropsychiatry Institute

La Jolla, California, 92037, United States

Location

UCLA Westwood - Semel Institute for Neuroscience and Human Behavior

Los Angeles, California, 90024, United States

Location

Stanford University

Stanford, California, 94305, United States

Location

Emory University

Atlanta, Georgia, 30329, United States

Location

Sheppard Pratt Health System

Baltimore, Maryland, 21204, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Washington University/Barnes Jewish Hospital

St Louis, Missouri, 63110, United States

Location

New York University

New York, New York, 10016, United States

Location

Laureate Institute for Brain Research

Tulsa, Oklahoma, 74136, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Butler Hospital

Providence, Rhode Island, 02906, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Brain Health Consultants

Houston, Texas, 77046, United States

Location

MeSH Terms

Conditions

Depressive Disorder; Depression; Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Limitations and Caveats

* Sham device used exaggerated vibration at the IAF which may have provided active treatment in the form of trigeminal nerve stimulation * Short wash-out period may have negatively impacted results. * Short treatment duration may limit efficacy

Results Point of Contact

• Title: Meagan Kovacs, Clinical and Regulatory Affairs Manager
• Organization: Wave Neuroscience

meagan@waveneuro.com

9492292869

Study Officials

• Andrew Leuchter, MD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-Blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Sham Controlled

Study Record Dates

• First Submitted: September 18, 2017
• First Posted: September 20, 2017
• Study Start: November 27, 2017
• Primary Completion: March 1, 2019
• Study Completion: June 1, 2019
• Last Updated: September 5, 2021
• Results First Posted: September 5, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (14)