Recruiting

Non-Invasive Stimulation

Sponsor:

Wake Forest University Health Sciences

Code:

NCT07143838

Conditions

Depression - Major Depressive Disorder

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Interventions

Transcranial Electrical Stimulation (TES)

Study Details

Brief summary:

The goal of this pilot study is to determine if non-invasive brain stimulation during sleep can increase deep sleep in adults with depression. It will also determine if increased deep sleep improves cognitive performance and mood ratings. Participants will be asked to wear a non-invasive device that records their brain activity and delivers transcranial electrical stimulation during sleep. Participants will also wear an actigraphy watch that measures activity levels throughout the study. In addition, participants will complete several cognitive assessments and mood and sleep questionnaires throughout the study.

Conditions

Depression - Major Depressive Disorder

Study ID

NCT07143838

Start date

Jun 4, 2026

Status verified date

Jun, 2026

Completion date

Mar, 2027

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Ability to complete overnight sleep study including placement of EEG leads
  • Ability to read and understand English.
  • Moderate depression
  • Self-reported cognitive complaints

Exclusion Criteria:

  • Previous adverse reaction to transcranial electrical stimulation
  • Presence of implanted devices (e.g. intracranial device, cochlear implant)
  • Presence of metal in head (e.g. surgical clip)
  • Sensitivity or allergy to silver
  • Presence of significant neurologic disease (e.g. Parkinson's disease, epilepsy/seizure disorder, severe migraine disorder)
  • History of significant head trauma
  • History of stroke or other ischemic event
  • Diagnosed with schizophrenia, bipolar disorder, substance use disorder, or presence of current suicidal ideation
  • Currently taking medications that could alter EEG or cognitive function
  • Presence of severe insomnia
  • Presence of severe, untreated sleep apnea
  • Currently pregnant
  • Planned travel outside time zone during the study

Study Design

Enrollment

12 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Transcranial Electrical Stimulation (TES)

All participants will receive transcranial electrical stimulation (TES) during sleep

Interventions

Transcranial Electrical Stimulation (TES)

Using the Sleep WISP device, transcranial electrical stimulation will be delivered during sleep as 0.5 Hz sine wave, 0.5 mA, between frontal (frontopolar and inferior lateral frontal) and posterior (mastoid and occipital) electrodes.

Primary outcome measure

  • Duration of Stage N3 Sleep [ Time Frame: From baseline to week 3 ]
  • Percentage of N3 Sleep [ Time Frame: From baseline to week 3 ]

Central Contacts and Locations

Central contacts

Ruth Benca, MD, PhD

336-716-2911ruth.benca@advocatehealth.org

Caitlin Carroll, PhD

336-716-2440caitlin.carroll@advocatehealth.org

Locations

Wake Forest University Health Sciences

Recruiting

Winston-Salem, North Carolina, United States, 27104

Contacts

Ruth Benca, MD PhD

336-716-2911ruth.benca@advocatehealth.org

Caitlin Carroll, PhD

336-716-2440caitlin.carroll@advocatehealth.org

More Information

Sponsor

Wake Forest University Health Sciences

Last update posted

Jun 29, 2026

Last verified

Jun, 2026

Keywords

  • Sleep
  • Depression

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Wake Forest University Health Sciences on 2026-06-29.