Assessing the Effects of Hormones on Noninvasive Transcranial Stimulation

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-40
SponsorCarnegie Mellon University

About this trial

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.

Eligibility criteria

Qualifiers

Age between 18 and 40 years old

Female subjects must have regular menstrual cycles (defined as a cycle that occurs at predictable intervals, typically between 24 and 38-days length) via self-report

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Transcranial Electrical Stimulation
  • Transcranial Magnetic Stimulation
  • TES + TMS

Treatment groups

25 Participants
are divided into 3 treatment groups

Sponsors and collaborators