Major DepressionNCT06824415
Sleep TMS for Depression
A study testing TMS in people with Major Depression and Sleep, run by Stanford University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Depression, Sleep
- What is being tested?
- TMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2025to 30 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Intellectual disability
- Significant head injury/neurological disorder
- Pregnancy or postpartum
- TMS/MRI contraindications
- Active substance use/suicidal ideation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Stanford University
Stanford, California, 94305
Hansong Lee, MS, 408-909-2203, kellerlab@stanford.edu
About this study
Official title: Optimizing Depression Treatment Through Sleep-state Brain Stimulation
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.
Read the detailed description
Healthy control participant cohort funded through K99MH141192 and depressed patient cohort funded through K99MH141192 and UM1TR004921.
- Conditions
- Major Depression, Sleep
- Being tested
- TMS
- Keywords
- sleep, tms, eeg, iTBS, real-time, closed-loop, NREM, sleep spindle, slow oscillations
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TMSDevice
Transcranial magnetic stimulation (TMS) applies magnetic pulses to stimulate nerve cells in the brain.
| Study group | Role | What they receive |
|---|---|---|
| Active TMS, Sham TMS | Experimental | 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 wakefulness and/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. Receives: Device: TMS |
| Sham TMS, Active TMS | Experimental | 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 wakefulness and/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. Receives: Device: TMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Baseline TMS-EEG after iTBS
Changes in Early Local TMS-Evoked Potentials (EL-TEP) following 3 minutes of either active or sham iTBS in each session to assess cortical excitability and plasticity measures.
- tbs; 2) sleep (cortical excitability and plasticity measures) in both active and sham.
Measured: Baseline, end of iTBS (3 minutes)
Change in Baseline TMS-EEG after NREM Sleep
Changes in Early Local TMS-Evoked Potentials (EL-TEP) following 3 hours of NREM sleep in each session to assess cortical excitability and plasticity measures.
Measured: Baseline, end of sleep stage (3 hours)
Change in N-back Accuracy Performance
N-back task (15-min) measures working memory performance and accuracy will be determined by the number of correct responses to the stimulus. Change in accuracy performance will be assessed before and after NREM sleep.
Measured: Baseline, end of sleep stage (3 hours)
Change in N-back Reaction Time Performance
N-back task (15-min) measures working memory performance and reaction time will be determined by the time it takes for the participant to respond to the stimulus. Change in reaction time performance will be assessed before and after NREM sleep.
Measured: Baseline, end of sleep stage (3 hours)
Change in MSIT Accuracy Performance
Multi-source Interference Task (MSIT; 15-min) measures cognitive control performance and accuracy will be determined by the number of correct responses to the stimulus. Change in accuracy performance will be assessed before and after NREM sleep.
Measured: Baseline, end of sleep stage (3 hours)
Change in MSIT Reaction Time Performance
Multi-source Interference Task (MSIT; 15-min) measures cognitive control performance and reaction time will be determined by the time it takes for the participant to respond to the stimulus. Change in reaction time performance will be assessed before and after NREM sleep.
Measured: Baseline, end of sleep stage (3 hours)
Secondary outcomes (4)
Changes in Pittsburgh Sleep Quality Index (PSQI) Scores
The Pittsburgh Sleep Quality Index (PSQI) contains 19 self-rated questions which measures seven aspects of sleep: (1) subjective sleep quality, (2) sleep latency, (3) sleep duration, (4) habitual sleep efficiency, (5) sleep disturbances, (6) use of sleeping medication, and (7) daytime dysfunction. The 19 self-rated items are combined to form seven component scores, each of which has a range of 0-3 points (0 indicates no difficulty, while 3 indicates severe difficulty). The seven component scores are then summed to yield one global score, with a range of 0-21 points (0 indicating no difficulty, and 21 indicating severe difficulties in all the seven areas of sleep quality).
Measured: After each sleep session (3 hours)
Changes in Treatment Tolerability
Treatment tolerability will be assessed through subject-reported comfort ratings on loudness, scalp sensation, and pain perception on scales ranging from 0 to 10.
Measured: After each sleep session (3 hours)
Change in EEG Spectral Power and Phase Measures
Changes in EEG spectral power and phase-related measures across predefined frequency bands following iTBS to assess neural oscillatory activity.
Measured: Baseline, end of sleep stage (3 hours)
Change in Functional Connectivity Measures
Changes in phase-based relationships between EEG sensors to assess connectivity changes following iTBS.
Measured: Baseline, end of sleep stage (3 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2025
- Study start1 May 2025
- Primary completion30 May 2028 (estimated)
- Study completion30 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major DepressionStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS), National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Umair Hassan, Stanford University
- Investigators
- Umair Hassan, PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06824415
- Sponsor's protocol ID
- 60980-3
- Other IDs
- UM1TR004921, K99MH141192
- Status last verified
- Jun 2026
- First submitted
- 7 Feb 2025
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Depression Treatment Through Sleep-state Brain Stimulation
- ClinicalTrials.gov ID
- NCT06824415
- Acronym / sponsor ID
- 60980-3
- Conditions
- Major Depression, Sleep
- Keywords
- sleep, tms, eeg, iTBS, real-time, closed-loop, NREM, sleep spindle
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS), National Institute of Mental Health (NIMH)
- Study start
- 1 May 2025 (actual)
- Primary completion
- 30 May 2028 (estimated)
- Study completion
- 30 May 2028 (estimated)
- First posted
- 13 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active TMS, Sham TMS | Experimental | Device: TMSParticipants 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 wakefulness and/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. |
| Sham TMS, Active TMS | Experimental | Device: TMSParticipants 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 wakefulness and/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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- Intellectual disability
- Significant head injury/neurological disorder
- Pregnancy or postpartum
- TMS/MRI contraindications
- Active substance use/suicidal ideation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TMSTranscranial magnetic stimulation (TMS) applies magnetic pulses to stimulate nerve cells in the brain. | Device | Active TMS, Sham TMS, Sham TMS, Active TMS |
Primary outcome
Change in Baseline TMS-EEG after iTBS
Time frame: Baseline, end of iTBS (3 minutes)
Changes in Early Local TMS-Evoked Potentials (EL-TEP) following 3 minutes of either active or sham iTBS in each session to assess cortical excitability and plasticity measures. 1) tbs; 2) sleep (cortical excitability and plasticity measures) in both active and sham.
Change in Baseline TMS-EEG after NREM Sleep
Time frame: Baseline, end of sleep stage (3 hours)
Changes in Early Local TMS-Evoked Potentials (EL-TEP) following 3 hours of NREM sleep in each session to assess cortical excitability and plasticity measures.
Change in N-back Accuracy Performance
Time frame: Baseline, end of sleep stage (3 hours)
N-back task (15-min) measures working memory performance and accuracy will be determined by the number of correct responses to the stimulus. Change in accuracy performance will be assessed before and after NREM sleep.
Change in N-back Reaction Time Performance
Time frame: Baseline, end of sleep stage (3 hours)
N-back task (15-min) measures working memory performance and reaction time will be determined by the time it takes for the participant to respond to the stimulus. Change in reaction time performance will be assessed before and after NREM sleep.
Change in MSIT Accuracy Performance
Time frame: Baseline, end of sleep stage (3 hours)
Multi-source Interference Task (MSIT; 15-min) measures cognitive control performance and accuracy will be determined by the number of correct responses to the stimulus. Change in accuracy performance will be assessed before and after NREM sleep.
Change in MSIT Reaction Time Performance
Time frame: Baseline, end of sleep stage (3 hours)
Multi-source Interference Task (MSIT; 15-min) measures cognitive control performance and reaction time will be determined by the time it takes for the participant to respond to the stimulus. Change in reaction time performance will be assessed before and after NREM sleep.
4 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Major Depression
RecruitingPhase 2
Study of Neuro-Cognitive Correlates of Pediatric Anxiety Disorders
Anxiety Disorders, Major Depressive Disorder
RecruitingPhase 2
Psilocybin-assisted Therapy for Comorbid Major Depressive Disorder and Alcohol Use Disorder
Major Depressive Disorder (MDD), Alcohol Use Disorder (AUD)
Recruiting
Defining Neurobiological Links Between Substance Use and Mental Illness
Major Depressive Disorder, Substance Use Disorder
RecruitingPhase 1
Neuropharmacologic Imaging and Biomarker Assessments of Response to Acute and Repeated-Dosed Ketamine Infusions in Major Depressive Disorder
Healthy Volunteer, Major Depressive Disorder
Recruiting
Psychopharmacotherapy for Depressive Patients
Major Depressive Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Umair Hassan, PhD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TMS in people with Major Depression and Sleep, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hansong Lee, MS (408-909-2203, kellerlab@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Baseline TMS-EEG after iTBS (time frame: Baseline, end of iTBS (3 minutes)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2026.