NCT07375732

Transcranial Electrical Stimulation for Noninvasive Study of Menopausal/Perimenopausal Symptoms

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Carnegie Mellon University · Academic / Other
• Sex: Female
• Age: 40 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

The purpose of this study is to assess the tolerability of transcranial electrical stimulation of the brain, and explore the response of TES on menopausal/perimenopausal symptoms including vasomotor effects , depression/anxiety, memory-problems. Electrical stimulation comprises a pattern of electrical currents that are delivered into the skin non-invasively using an array of electrodes adhered to the skin surface. Pain administration and sensory testing may be performed using thermodes, which are devices attached to limbs whose temperature is controlled using a computer (heat and cold pain). Temperature will be varied across time and heat/cold delivered to assess any changes in self-reported pain and/or non-invasive Electroencephalography (EEG) and functional Near-Infrared Spectroscopy (fNIRS). Examining the association of locations of current delivery with changes in self-reported pain and EEG/fNIRS recordings will help assess the spatiotemporal dynamics in the brain relevant to pain perception and the nature of their effects on pain (e.g. increase or decrease). Prior to testing the effects on pain, the individual's primary motor cortex may be localized by delivering short pulses at locations close to the motor cortex and measuring muscle responses using electromyography (EMG) electrodes placed on muscles (e.g. on the arms and legs). The participant's resting state and pain-evoked brain activity will also be recorded using non-invasive Electroencephalography (EEG) and functional Near-Infrared Spectroscopy (fNIRS). The stimulation techniques - called SharpFocus Transcranial Electrical Stimulation (SharpFocus TES) - consist of patch arrays (a set of electrodes arranged in a grid and embedded in a flexible substrate that conforms to the skin surface) or individual electrodes being installed at various locations including the head, arms, and legs. Some of the electrodes on the scalp inject current for brain stimulation. The rest of the electrodes are for recording. Conductive cream, gel, or hydrogel is placed between the electrode and skin to improve adhesion and conductivity. Additionally, or alternatively, classic cup (e.g. gold-cup) electrodes (10 mm diameter or 6 mm diameter), used routinely in the clinic, might also be used, especially for participants with thick or long hair. A multichannel electrical stimulator connects to the electrode array to deliver pulses of electrical current that are varied in timing, intensity, and location to allow fine-grained control of the site(s) of stimulation in the brain. For sensory effects, participants will be asked to report any modulation of pain sensation they feel on electrical stimulation. Experiments will be performed to measure effects on muscle activity and perceived sensations. Results from these experiments will be used to verify and refine computational models that have been developed to simulate biophysical effects of SharpFocus TES. Furthermore, it will aid in the understanding of how the central nervous system affects several of the symptoms seen in menopause/perimenopause. The ultimate goal of this research is to create a wearable interface that can stimulate parts of the cortex for a variety of applications pertaining to menopause/perimenopause.

Conditions

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

Interventions

Type	Name	Description
DEVICE	Transcranial Electrical Stimulation	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.

Timeline

• Start date: 2026-02-01
• Primary completion: 2026-12-01
• Completion: 2027-04-01
• First posted: 2026-01-29
• Last updated: 2026-01-29