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Recruiting NCT06824415

Sleep TMS for Depression

No phase Interventional Major Depression Sleep

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: TMS.
Who it may be relevant to
Registry conditions: Major Depression, Sleep. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Optimizing Depression Treatment Through Sleep-state Brain Stimulation

Overview

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

Healthy control participant cohort funded through K99MH141192 and depressed patient cohort funded through K99MH141192 and UM1TR004921.

Interventions

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

Primary outcome measures

  • Change in Baseline TMS-EEG after iTBS [Time frame: Baseline, end of iTBS (3 minutes)]
  • Change in Baseline TMS-EEG after NREM Sleep [Time frame: Baseline, end of sleep stage (3 hours)]
  • Change in N-back Accuracy Performance [Time frame: Baseline, end of sleep stage (3 hours)]
  • Change in N-back Reaction Time Performance [Time frame: Baseline, end of sleep stage (3 hours)]
  • Change in MSIT Accuracy Performance [Time frame: Baseline, end of sleep stage (3 hours)]
  • Change in MSIT Reaction Time Performance [Time frame: Baseline, end of sleep stage (3 hours)]
Secondary outcome measures (4)
  • Changes in Pittsburgh Sleep Quality Index (PSQI) Scores [Time frame: After each sleep session (3 hours)]
  • Changes in Treatment Tolerability [Time frame: After each sleep session (3 hours)]
  • Change in EEG Spectral Power and Phase Measures [Time frame: Baseline, end of sleep stage (3 hours)]
  • Change in Functional Connectivity Measures [Time frame: Baseline, end of sleep stage (3 hours)]

Eligibility criteria

Inclusion criteria

  • Adults ages 18-65 years
  • Current Major Depressive Disorder (MDD) diagnosis
  • Failed ≥1 antidepressant medication
  • Moderate-to-severe depression
  • Stable antidepressant medication dose for ≥ 6 weeks prior to enrollment
  • Healthy control participants are adults ages 18-65 years without current MDD symptoms, not taking antidepressant or antipsychotic medications, and without major psychiatric, neurological, substance use, medical conditions affecting brain function, or TMS/MRI contraindications.

Exclusion criteria

  • Intellectual disability
  • Significant head injury/neurological disorder
  • Pregnancy or postpartum
  • TMS/MRI contraindications
  • Active substance use/suicidal ideation

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Double blind
Primary purpose
Basic science

Study locations

United States · 1 center
  • Stanford University — Stanford

Identifiers

NCT: NCT06824415 · 60980-3 · UM1TR004921 · K99MH141192

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗