Treatment of Depression With Connectivity Guided Robotically Delivered rTMS

NCT02802293 | Terminated Results DMC FDA Device

• 1 other identifier: HSC20160129H
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the clinical effects (if any) of connectivity-guided repetitive transcranial magnetic stimulation (rTMS) in the treatment of major depressive disorder (MDD) to provide clues about the ideal neural networks to target for more robust clinical outcomes, and to identify potential biomarkers of treatment response including changes in brain network connectivity.

Conditions

Major Depressive Disorder

Keywords

Repetitive Transcranial Magnetic Stimulation; Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• Change in Depression Severity (MADRS)

  Measured by the Montgomery-Ashberg Depression Rating Scale. This is a 10-item diagnostic questionnaire with an overall score range from 0 to 60. A higher score indicates more severe depression: 0 to 6 - normal/symptom absent 7 to 19 - mild depression 20 to 34 - moderate depression \>34 - severe depression.

  Baseline to four weeks (the conclusion of rTMS treatment)

Secondary Outcomes (6)

• Change in Depression Severity (MADRS)

  Baseline to sixteen weeks (twelve weeks after the conclusion of rTMS treatment)

• Clinically Significant Response (MADRS)

  Baseline to four weeks (the conclusion of rTMS treatment)

• Clinically Significant Response (MADRS)

  Baseline to sixteen weeks (twelve weeks after the conclusion of rTMS treatment)

• Remission From Depression (MADRS)

  Baseline to four weeks (the conclusion of rTMS treatment)

• Remission From Depression (MADRS)

  Baseline to sixteen weeks (twelve weeks after the conclusion of rTMS treatment)

Study Arms (3)

Standard rTMS Aiming

ACTIVE COMPARATOR

Active repetitive transcranial magnetic stimulation (rTMS) will be delivered to the left DLPFC using the standard aiming strategy with the rTMS coil positioned using a robotic arm. In this arm, rTMS will be delivered at 10 Hz in 4 sec trains with 26 sec inter-train intervals, 37.5 minutes/session (i.e. 3,000 pulses/session), 5 sessions/week, for 4 weeks.

Device: repetitive transcranial magnetic stimulation; Device: robotic arm

Anterior DLPFC targeting

ACTIVE COMPARATOR

Active rTMS will be delivered to the left anterior DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm. In this arm, rTMS will be delivered at 10 Hz in 4 sec trains with 26 sec inter-train intervals, 37.5 minutes/session (i.e. 3,000 pulses/session), 5 sessions/week, for 4 weeks.

Device: repetitive transcranial magnetic stimulation; Device: robotic arm

Posterior DLPFC targeting

ACTIVE COMPARATOR

Active rTMS will be delivered to the left posterior DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm. In this arm, rTMS will be delivered at 10 Hz in 4 sec trains with 26 sec inter-train intervals, 37.5 minutes/session (i.e. 3,000 pulses/session), 5 sessions/week, for 4 weeks.

Device: repetitive transcranial magnetic stimulation; Device: robotic arm

Interventions

repetitive transcranial magnetic stimulation DEVICE

The MagPro R30 is an advanced, high performance magnetic stimulator designed primarily for non-invasive clinical use. The non-invasive brain stimulation system will be used to deliver repetitive electromagnetic pulses in this research study's treatment of major depressive disorder.

Also known as: rTMS

Anterior DLPFC targeting; Posterior DLPFC targeting; Standard rTMS Aiming

robotic arm DEVICE

This robotic system is based on a commercially available neurosurgical robot. The robot is mounted on a mobile (i.e. retractable wheels) cart which holds the robot controller and the TMS power supply and pulse-generation computer. The robotic system will be used for TMS coil positioning/targeting.

Anterior DLPFC targeting; Posterior DLPFC targeting; Standard rTMS Aiming

Eligibility Criteria

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

You may qualify if:

• Males or females with MDD receiving treatment at the iKare Mood Trauma Recovery Clinic between the ages of 18-65 years;
• Meeting the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-V) criteria for MDD as determined using the Mini-International Psychiatric Interview (MINI)
• Meeting the Patient Health Questionnaire-9 (PHQ-9 \> 14) and/or the Structured Interview Guide for the Montgomery-Ashberg Depression Rating Scale (SIGMA\>18) criteria for treatment resistance in MDD despite completing at least one adequate trial of an Selective Serotonin Reuptake Inhibitor (SSRI) or Serotonin-Norepinephrine Reuptake Inhibitor (SNRI) at an FDA-recommended dose for at least 6-8 weeks.
• Subjects on SSRIs or other antidepressants, hypnotic medications including modulators of Gamma-Aminobutryic Acid (GABA)-A receptor function, trazodone, atypical neuroleptic or other psychotropic medications such as prazosin may enter the study if they are deemed to be on a stable dose of their medication.
• Able to provide written informed consent.
• Able to read and write English.

You may not qualify if:

• Subjects with a diagnostic history of bipolar disorder, schizophrenia or schizoaffective disorder or currently exhibiting psychotic features as confirmed by MINI.
• Substance use disorder during the 3 months prior to screening; except for Mild or Moderate Alcohol Use Disorder according to DSM-V criteria.
• Any history or signs of serious medical or neurological illness including seizure disorders. Except for seizures, a subject with a clinical abnormality may be included only if the study clinician considers the illness will not introduce additional risk and will not interfere with the study procedures.
• Females will be excluded if they are pregnant (i.e. positive pregnancy test identified after their intake at the treatment clinic).
• History of traumatic brain injury (TBI) with loss of consciousness for 20 minutes or more as determined by the Brief Traumatic Brain Injury Screen (TBI Screening Tool).
• Any history or signs of metal objects (e.g. surgical clips, cardiac pacemakers, metal implants, etc.) in the body at the time of screening. MRI can have risks for persons with foreign bodies implanted in their body.

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead
• IKARE Mood, Trauma, Recovery Clinic: collaborator

Study Sites (1)

Ikare, Mood, Trauma, Recovery Clinic

San Antonio, Texas, 78229, United States

Location

Related Publications (1)

• O'Reardon JP, Solvason HB, Janicak PG, Sampson S, Isenberg KE, Nahas Z, McDonald WM, Avery D, Fitzgerald PB, Loo C, Demitrack MA, George MS, Sackeim HA. Efficacy and safety of transcranial magnetic stimulation in the acute treatment of major depression: a multisite randomized controlled trial. Biol Psychiatry. 2007 Dec 1;62(11):1208-16. doi: 10.1016/j.biopsych.2007.01.018. Epub 2007 Jun 14.

  PMID: 17573044 BACKGROUND

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Results Point of Contact

• Title: Felipe S. Salinas, Ph.D.
• Organization: University of Texas Health -- San Antonio

salinasf@uthscsa.edu

210-567-8214

Study Officials

• Felipe S Salinas, Ph.D.

  The University of Texas Health Science Center at San Antonio

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: June 13, 2016
• First Posted: June 16, 2016
• Study Start: August 17, 2017
• Primary Completion: March 23, 2021
• Study Completion: March 23, 2021
• Last Updated: August 25, 2022
• Results First Posted: August 25, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)