Transcranial Electrical Stimulation for Noninvasive Study of Menopausal/Perimenopausal Symptoms

NCT07375732 | Not Yet Recruiting

• 1 other identifier: STUDY2025_00000313
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Menopause Related Conditions; Menopausal Depression; Menopause Hot Flashes; Menopause

Keywords

Noninvasive Neuromodulation; Transcranial Electrical Stimulation; Depression; Vasomotor Symptoms; Hot Flashes

Outcome Measures

Primary Outcomes (5)

• Depression

  Menopause related depression will be queried using the Menopause Depression Rating Scale (Meno-D) questionnaire as well as the CES-D inventory prior to and at the end of each arm. The Meno-D is a 12-item self-report or clinician-rated scale specifically developed to assess depression during the perimenopausal transition. It captures unique symptom clusters such as irritability, memory issues, low energy, and somatic complaints not typically addressed in general depression scales. The minimum score is 0 and the maximum is 48 points.Between 20-24 points is considered to denote mild perimenopausal depression, needing onward monitoring. Between 24-32 points suggests moderate perimenopausal depression needing treatment. At 32 points and above, the woman is considered to have severe perimenopausal depression needing treatment.

  From enrollment to the end of treatment at 22 days

• Sleep Quality

  Sleep quality will be measured using the Pittsburgh Sleep Quality Index (PSQI). The PSQI is a widely used self-report questionnaire that assesses overall sleep quality and disturbances over the past month. It includes 19 items grouped into seven domains: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. Total global score ranges from 0 to 21. Higher scores indicate poorer sleep, with a total score above 5 suggesting significant sleep impairment.

  Study enrollment to end of study at 22 days

• Menopause Quality of Life

  Quality of life will be measured using the Menopause rating scale (MRS) survey. The MRS is a validated, self-administered tool designed to assess health-related quality of life in midlife women. It measures the severity of 11 common menopausal symptoms across three domains: psychological, somato-vegetative, and urogenital to evaluate symptom burden and changes over time, including before and after treatment. Scores range from 0 to 44 with 0 being no menopausal symptoms and 44 being severe menopausal symptoms.

  Upon enrollment to 22 days

• Center for Epidemiological Studies-Depression Inventory (CES-D)

  General depressive symptoms will be measured with the Center for Epidemiological Studies-Depression Inventory (CES-D). The CES-D is a 20-item self-report measure designed to assess depressive symptoms experienced over the past week. Items cover mood, somatic complaints, and interpersonal difficulties, with responses rated on a 4-point scale. Higher total scores reflect more severe depressive symptoms, with a score of 16 or above suggesting risk for clinical depression. The scale ranges from a minimum of 0 (indicating very low depression) to a maximum of 60 (indicating high depressive symptoms).

  Upon enrollment to 22 days

• Numerical Rating Scale

  A numerical rating scale (NRS) uses numbers to quantify subjective experiences of pain. NRS scores will be self-reported on a scale of 0-10 with 0 being no pain and 10 being worst pain imaginable. NRS will be presented to patients during calibration phases of Transcranial Electrical Stimulation (TES), during heat pain thresholding, and during pressure pain thresholding in the form of a visual scale and be asked to vocalize a number between 0 and 10 in response to a pain stimulus.

  Upon enrollment to 22 days

Secondary Outcomes (9)

• Pain Catastrophizing Scale

  Upon enrollment to 22 days

• Impulsive Behavior Scale

  Upon enrollment to 22 days

• Brief Pain Inventory

  Upon enrollment to 22 days.

• Electromyography Recording

  Upon enrollment to 22 days

• Sternal Skin Conductance

  Upon enrollment to 22 days

Study Arms (2)

Stimulation of Occipital Cortex

SHAM COMPARATOR

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.

Device: Transcranial Electrical Stimulation

Motor Cortex Stimulation

EXPERIMENTAL

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.

Device: Transcranial Electrical Stimulation

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.

Motor Cortex Stimulation; Stimulation of Occipital Cortex

Eligibility Criteria

• Age: 40 Years - 60 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age between 40 and 60 years
• Participants falling under stages -2 to +2 in the Stages of Reproductive Aging Workshop (STRAW +10) as defined below:
• Early menopause transition (Stage -2): Increased variability in menstrual cycle defined as persistent difference of 7 days or more in the length of consecutive cycles. Persistence is defined as recurrence within 10 cycles of the first variable cycle.
• Late menopause transition (Stage -1): Occurrence of amenorrhea of 60 days or longer.
• Final Menstrual Period (Stage 0): Have undergone 12 consecutive months without a menstrual period, not due to other medical causes.
• Early Postmenopause (Stage +1): 5-8 years after final menstrual period.
• Late Postmenopause (Stage +2): \>8 years after final menstrual period.
• Participants having frequent hot flashes (at least once a day).

You may not qualify if:

• Disorders that may mask or coincide with menopause and peri-menopause, such as: Primary Ovarian Insufficiency, Thyroid disease (Hyper/hypothyroidism), Hyperprolactinemia, Cushing's syndrome, Endometrial/Ovarian Cancer, Polycystic Ovary Syndrome (PCOS), Functional hypothalamic amenorrhea
• Concurrent drugs:
• GnRH agonist/antagonist
• Tamoxifen/aromatase inhibitors
• Other conditions: Recent hematoma (\<48 hours), History of hemorrhagic disorders (any platelet disorder (ITP, TTP, HUS, Glanzmann thrombasthenia), Hemophilia A/B, history of arterial insufficiency, any prior history of malignancy, current pregnancy, a lifetime history of severe, uncontrolled mood disorders (anxiety, depression, bipolar), psychotic disorders, other neural disorders, or heart disease, any condition that makes them unable to perform tasks outlined in experiment, tattoos on sensory testing sites.

Sponsors & Collaborators

• Carnegie Mellon University: lead

MeSH Terms

Conditions

Depression; Hot Flashes

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Central Study Contacts

Pulkit Grover, PhD

CONTACT

412-268-3644; pgrover@andrew.cmu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DEVICE FEASIBILITY
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 20, 2026
• First Posted: January 29, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: January 29, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share