Brain-Based Biomarkers in Response to TMS in MDD | NCT02843373

Studies
Brain-Based Biomarkers in Response to TMS in MDD

NCT02843373

Sponsor

Stanford University

Status

Completed

Last Update Posted

Jun 23, 2022Actual

Enrollment

54Actual

Phase

Not provided

Conditions

Major Depressive Disorder
Depression

Interventions

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2016

Primary Completion Date

Dec 2019Actual

Completion Date

Dec 2019Actual

First Submitted Date

Jul 20, 2016

First Submission Date that Met QC Criteria

Jul 20, 2016

First Posted Date

Jul 25, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 17, 2022

Last Update Posted Date

Jun 23, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Corey Keller, Assistant Professor of Psychiatry and Behavioral Sciences, Stanford UniversityPrincipal Investigator

Lead Sponsor

Stanford UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The overarching goal of this research program is to elucidate causal and directional neural network- level abnormalities in depression, and how they are modulated by an individually-tailored, circuit-directed intervention. By using concurrent TMS and EEG, the investigators can overcome a major limitation of EEG - the inability to demonstrate causality. Here, we plan to recruit patients with medication-resistant depression undergoing rTMS treatment. At multiple time points, we will perform TMS-EEG to investigate the excitability and connectivity profiles of brain networks and how they are modulated during treatment. This study aims to provide objective brain network measures that can predict and track clinical response to TMS treatment. Findings from this study will be utilized to develop a novel, personalized treatment protocol based on individual brain networks.

Detailed Description

Goals of the study are as follows:

To evaluate the ability to predict and track brain network changes during TMS treatment for medication-resistant depression.
To develop quantitative tools that measure the connectivity and excitability of the brain using resting and single pulse TMS-EEG.
To determine the feasibility of recording EEG biomarkers in the clinic without disrupting clinical care.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

54Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
rTMS		rTMS will be delivered for 20 sessions over 4 weeks. Active 10 Hz rTMS will be delivered to the left DLPFC as assessed by either the 5cm rule or F3 site. Daily treatment regiments will last 36.5 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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
TMS	Device		rTMS

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
TMS-EEG	From pre- to post-treatment, improvement will be based on enhanced excitability and connectivity	Up to 3 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Men and women, ages 18 to 60
Medication-resistant depression as assessed by psychiatrist
Must comprehend English well to ensure adequate comprehension of the EEG and TMS instructions, and of clinical scales
Has failed >1 previous adequate antidepressant medication trials
Right-handed
No current or history of neurological disorders
No seizure disorder or risk of seizures
No use of PRN medication within 48 hours of the scheduled study appointment

Exclusion Criteria:

Any unstable medical condition, any significant CNS neurological condition such as stroke, seizure, tumor, hemorrhage, multiple sclerosis, etc
Current electroconvulsive therapy (ECT) or prior treatment failure with ECT
Currently pregnant or breastfeeding

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Community care clinic

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Corey Keller, MD PhD	Stanford University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Stanford University		Palo Alto	California	94304	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003865	Depressive Disorder, Major
D003863	Depression

Ancestor Terms

ID	Term
D003866	Depressive Disorder
D019964	Mood Disorders
D001523	Mental Disorders
D001526	Behavioral Symptoms

Browse Leaves

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Browse Branches

Not provided