Transcranial Electrical Stimulation for Noninvasive Study of Menopausal/Perimenopausal Symptoms

Sponsor
Carnegie Mellon University
Study ID
NCT07375732
Status
Not Yet Recruiting

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Conditions

  • Menopausal Depression
  • Menopause
  • Menopause Hot Flashes
  • Menopause Related Conditions

Eligibility Criteria

Sex
FEMALE
Age
40 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • Transcranial Electrical Stimulation — DEVICE
    SharpFocus transcranial electrical stimulation (TES) uses a multichannel stimulator connected to a scalp electrode to deliver precisely timed, intensity-modulated electrical pulses. By varying the timing, amplitude, and location of these pulses, the system achieves focal stimulation of targeted cortical regions. Investigators will use Digitimer DS8R and/or Digitimer DS5 current stimulators to apply all current stimuli. These stimulators are CE certified and are intended for use in human research applications. The stimulator safely delivers brief duration (50-2000µs) current pulses for transcranial electrical stimulation and activation of nerves and muscles via surface electrodes. The current output of the DS8R is adjustable over the range 0mA to 1000mA, with a compliance voltage of up to 400V and an energy limit of 300mJ.

Study Details

Participants are being invited to a research study. This research aims to assess the tolerability of transcranial electrical stimulation of the brain, and explore the response of TES on menopausal/perimenopausal symptoms including hot flashes effects, depression/anxiety, memory-problems, and muscular problems. This study will assess what types of electrical brain stimulation affect different menopausal related symptoms. This study will help guide the development of electrical stimulation to be used for improving women's health during menopause transition.

Key Dates

First listed
Jan 29, 2026
Start date
Feb 28, 2026
Status verified
Jan 2026
Primary completion
Dec 31, 2026
Completion
Apr 30, 2027

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DEVICE_FEASIBILITY

Arms

  • Sham Comparator: Stimulation of Occipital Cortex
    Transcranial Electrical Stimulation will be delivered to the occipital cortex (mapped using the 10 20 EEG system) at a similar current/pain level as the active stimulation trial.
  • Experimental: Motor Cortex Stimulation
    Transcranial electrical stimulation will be delivered to the primary motor cortex (mapped using the 10-20 EEG system) and current will be injected such that there are evoked motor potentials in the distal extremities.

Primary Outcome Measure

Depression [ Time Frame: From enrollment to the end of treatment at 22 days ]

Central Contacts

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