rTMS Study in Depression to Evaluate the Relationship Between Brain Plasticity and Clinical Outcome

NCT04032015 | Withdrawn FDA Device

• 1 other identifier: 133611
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Depression is a highly prevalent condition characterized by persistent low mood, energy, and activity that can affect one's thoughts, mood, behavior, and sense of well-being. Repetitive transcranial magnetic stimulation (rTMS), a non-invasive neuromodulatory technique, is an effective treatment for depression. However, remission rates are suboptimal and ideal stimulation parameters are unknown. The overarching goal of this study is to elucidate how brain changes accumulate during rTMS, and how these changes relate to clinical outcome. I plan to recruit patients with medication-resistant depression and treat with four weeks of rTMS in a randomized, double-blind, sham-controlled fashion. I will measure brain changes using TMS-EEG and determine how these changes relate to clinical outcome. This study will 1) test how brain changes relate to clinical outcome and 2) establish a computational model to help predict outcome and propose novel treatment protocols.

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (2)

• TMS-EEG change

  Change in TMS-EEG measures will be assessed before, during, and after each treatment session. These changes will be compared to clinical outcome to identify clinically-relevant biomarkers.

  Up to 1 month

• Hamilton Depression Rating Scale (HamD)

  Clinician administered scale to assess depression is a 24-item clinician-administered assessment utilized as a way of determining a patient's level of depression before, during, and after treatment. It takes approximately 15-20 minutes to complete the interview and score the results.

  Up to 6 months after treatment

Study Arms (2)

rTMS treatment

ACTIVE COMPARATOR

rTMS will be delivered for 20 sessions over 4 weeks. Active 10 Hz rTMS will be delivered using neuro-navigation based on participants' own MRI images. Daily treatment regiments will last 30 minutes and rTMS will be delivered at 120% of the participant's motor threshold. Participants will be monitored during the rTMS sessions for adverse events and/or side effects.

Device: TMS

Sham treatment

SHAM COMPARATOR

Sham rTMS will be delivered for 20 sessions over 4 weeks. To maximize sham validity, both 1) a direction-sensor TMS coil will alert the operators to flip the coil if the wrong side is being used, and 2) low-intensity 10Hz electrical stimulation will be applied to scalp electrodes under the coil for sham and placed but not activated in the active arm. The rTMS coil will be positioned using neuro-navigation based on participants' own MRI images, mimicking active rTMS treatment. Daily treatment regiments will last 30 minutes and sham rTMS will be delivered at 120% of the participant's motor threshold. Participants will be monitored during the sham rTMS sessions for adverse events and/or side effects. Upon completing the 20 sham sessions, participants are unblinded and offered 20 treatments of active rTMS. The open-label treatment would follow the active rTMS treatment protocol.

Device: TMS

Interventions

TMS DEVICE

Device used to administer electromagnetic fields to the brain to alter connectivity patterns

Sham treatment; rTMS treatment

Eligibility Criteria

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

You may qualify if:

• English-speaking
• Right-handed
• Ages 18-65
• Depression diagnosis as assessed through an in-depth interview
• Failed at least 1 antidepressant medication
• Without current/history of neurological disorders or seizures or risk of seizures

You may not qualify if:

• A contraindication for MRIs (e.g. implanted metal)
• History of head trauma with loss of consciousness
• History of seizures
• Neurological or uncontrolled medical disease
• Active substance abuse
• Diagnosis of psychotic or bipolar disorder
• Prior history of ECT or rTMS failure
• Currently taking medications that substantially reduce seizure threshold
• Currently pregnant or breastfeeding.

Sponsors & Collaborators

• Stanford University: lead

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 22, 2019
• First Posted: July 25, 2019
• Study Start: January 1, 2020
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: April 14, 2021

Record last verified: 2021-04