Sleep TMS for Depression

Stanford University

Status: Not yet enrolling

Conditions: Major Depression; Sleep

Treatments: Device: TMS

Study type: Interventional

Funder types: Other

Identifiers

NCT06824415

60980-3

Details and patient eligibility

About

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.

Enrollment: 15 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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15 participants in 2 patient groups

Active TMS, Sham TMS

Experimental group

Description:

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.

Treatment:

Device: TMS

Sham TMS, Active TMS

Experimental group

Description:

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.

Treatment:

Device: TMS