Hormonal Effects on Brain Stimulation for Depression
What You Need to Know Before You Apply
What is the purpose of 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.
Are You a Good Fit for This Trial?
This trial is for healthy adults aged 18-40. Women must have regular menstrual cycles. The study includes both men and women to compare how brain stimulation works depending on hormone levels.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline Visit
Informed consent is reviewed and obtained, and participants complete a Demographic and Medical History and Menstrual Phase Identification Questionnaire (MPIQ) survey. Motor mapping is conducted to adjust TES, TMS, and joint TES+TMS parameters.
Treatment
Participants undergo repetitive stimulation with either TMS, TES, or joint TES+TMS across at most 16 days over the span of at most 6 months. Sessions are scheduled at specific points in the menstrual cycle for female participants.
Follow-up
Participants are monitored for safety and effectiveness after treatment. EMG responses and other metrics are recorded to assess changes in cortical excitability.
What Are the Treatments Tested in This Trial?
Interventions
- TES + TMS Combination
- Transcranial Electrical Stimulation (TES)
- Transcranial Magnetic Stimulation (TMS)
Trial Overview
Researchers are testing two types of non-invasive brain stimulation—transcranial electrical stimulation (TES) and transcranial magnetic stimulation (TMS)—alone and together, to see how they affect brain activity in relation to hormone changes.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Participants receive repetitive transcranial magnetic stimulation delivered to the primary motor cortex (M1), with sessions scheduled at two points per menstrual cycle - once at estrogen nadir (days 1-3) and once during the late follicular phase (days 10-14). Prior to the stimulation train, diagnostic TMS measuring SICI, LICI, and ICF is conducted to establish baseline cortical excitability. Participants then undergo a train of up to 2,000 pulses of standard rTMS or up to 600 pulses of iTBS (3 pulses at 50 Hz, burst repetition rate of 5 Hz, 2 seconds ON and 8 seconds OFF for 20 cycles at 80% motor threshold). Following the train, diagnostic TMS is repeated to assess changes in cortical excitability relative to baseline. Participants remain seated throughout the session.
Participants receive concurrent TMS and TES stimulation delivered to the primary motor cortex (M1), with sessions scheduled at two points per menstrual cycle - once at estrogen nadir (days 1-3) and once during the late follicular phase (days 10-14). Prior to the stimulation train, diagnostic TMS measuring SICI, LICI, and ICF is conducted to establish baseline cortical excitability. Participants then undergo a train of up to 2,000 paired TMS and TES pulses, with a 1-3 ms latency maintained between the two modalities. Following the train, diagnostic TMS is repeated to assess changes in cortical excitability relative to baseline. Participants remain seated throughout the session.
Participants receive focal electrical stimulation delivered to the primary motor cortex (M1), with sessions scheduled at two points per menstrual cycle - once at estrogen nadir (days 1-3) and once during the late follicular phase (days 10-14). Prior to the stimulation train, diagnostic TMS measuring SICI, LICI, and ICF is conducted to establish baseline cortical excitability. Participants then undergo a train of up to 2,000 TES pulses, with timing, amplitude, and location varied to achieve targeted cortical stimulation. Following the train, diagnostic TMS is repeated to assess changes in cortical excitability relative to baseline. Participants remain seated throughout the session.
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Who Is Running the Clinical Trial?
Carnegie Mellon University
Lead Sponsor
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