๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-06-04

Assessing the Effects of Hormones on Noninvasive Transcranial Stimulation (NCT07635017)

๐ŸŸก Not Yet Recruiting Observational / Diagnostic โš™๏ธ Medical Device Protocol Sponsor: Carnegie Mellon University

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

This study is investigating how two types of non-invasive brain stimulation, transcranial electrical stimulation (TES) and transcranial magnetic stimulation (TMS), affect brain activity, and whether combining them produces stronger or more consistent effects than either one used alone. The motivation for this comes from the observation that TMS, which is FDA-approved for treating depression, tends to work less well in postmenopausal women because lower estrogen levels reduce the brain's ability to respond to stimulation. The research team believes that pairing TMS with TES, which targets a different set of brain cells, may be able to overcome this hormonal barrier and make stimulation more effective. Participants will come into the lab for up to 24 visits over 8 months, beginning with an initial visit to establish the right stimulation settings, followed by a series of stimulation sessions in which brain activity is measured before and after receiving either TES, TMS, or both together. For female participants, sessions will be scheduled at specific points in the menstrual cycle to capture the natural monthly rise and fall of estrogen, while male participants will be scheduled on a comparable fixed interval as a comparison group. The insights gained from this study could directly inform the development of better, more reliable brain stimulation treatments for women with depression.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (2 items) and avoid the listed exclusions (9 items).

Location: Carnegie Mellon University โ€” Pittsburgh, Pennsylvania

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • Exclusion Criteria:
  • Allergies to henna
  • Allergies to gel used for electrodes
  • History of seizures or epilepsy
  • Subjects must not have any serious disease, disorder, infection, or cognitive impairments that could affect their ability to participate in this study.
  • Female subjects of child-bearing potential must not be pregnant
  • Subjects must not have any implanted stimulators or pulse generators
  • Subjects must not have heart disease, including known arrhythmia
  • Subjects must not have any metal implants in their head

๐Ÿ” Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

๐Ÿ“ All Participating Trial Locations (1 Sites)

  • Carnegie Mellon University โ€” Pittsburgh, Pennsylvania

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
๐Ÿ›๏ธ View Official NIH Record โ†—