Sleep TMS for Depression

NCT ID: NCT06824415

Last Updated: 2025-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-01

Study Completion Date

2025-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The goal of this study is to establish the feasibility, tolerability, and preliminary efficacy of sleep-state transcranial magnetic stimulation (TMS) for enhancing plasticity in depression treatment.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Major Depression Sleep

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Active TMS, Sham TMS

Participants will receive 2 sessions of Transcranial Magnetic Stimulation (TMS) delivered using standard intermittent theta-burst (iTBS) parameters (600 pulses, 3 min, 120% rMT). Participants will receive, on separate sessions, either active or sham iTBS delivered during pre-sleep wakefulness or NREM sleep stages while recording with Electroencephalography (EEG). Participants will perform the N-back task and Multi-source Interference Task (MSIT) during each session to measure working memory and cognitive control performance.

Group Type EXPERIMENTAL

TMS

Intervention Type DEVICE

Transcranial magnetic stimulation (TMS) applies magnetic pulses to stimulate nerve cells in the brain.

Sham TMS, Active TMS

Participants will receive 2 sessions of Transcranial Magnetic Stimulation (TMS) delivered during using standard intermittent theta-burst (iTBS) parameters (600 pulses, 3 min, 120% rMT). Participants will receive, on separate sessions, either active or sham iTBS delivered during pre-sleep wakefulness or NREM sleep stages while recording with Electroencephalography (EEG). Participants will perform the N-back task and Multi-source Interference Task (MSIT) during each session to measure working memory and cognitive control performance.

Group Type EXPERIMENTAL

TMS

Intervention Type DEVICE

Transcranial magnetic stimulation (TMS) applies magnetic pulses to stimulate nerve cells in the brain.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

TMS

Transcranial magnetic stimulation (TMS) applies magnetic pulses to stimulate nerve cells in the brain.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Current Major Depressive Disorder (MDD) diagnosis
* Failed \>= 1 antidepressant medication
* Moderate-to-severe depression

Exclusion Criteria

* Intellectual disability
* Significant head injury/neurological disorder
* Pregnancy or postpartum
* TMS/MRI contraindications
* Active substance use/suicidal ideation
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Center for Advancing Translational Sciences (NCATS)

NIH

Sponsor Role collaborator

Stanford University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Corey Keller

Associate Professor in Department of Psychiatry and Behavioral Sciences

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Corey J Keller, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Stanford University

Stanford, California, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

UM1TR004921

Identifier Type: NIH

Identifier Source: secondary_id

View Link

60980-3

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Spectral Correlation Coefficient-based TMS
NCT04040062 ENROLLING_BY_INVITATION NA
rTMS for Neuroenhancement
NCT06214871 RECRUITING NA
Testing a Transdiagnostic TMS Treatment Target
NCT06282146 ACTIVE_NOT_RECRUITING EARLY_PHASE1
In-patient SCC TMS
NCT05645575 RECRUITING NA
rTMS in First Episode Psychosis
NCT02131129 COMPLETED NA
Brain Stimulation and Decision-making
NCT04099056 RECRUITING NA