Transcranial Electrical Stimulation for Noninvasive Study of Menopausal/Perimenopausal Symptoms

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age40-60
SponsorCarnegie Mellon University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age between 40 and 60 years

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.

Disqualifiers

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

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.

Trial design

Design model

Crossover

Treatments tested in this trial

  • 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.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Stimulation of Occipital CortexSham comparator 1 intervention
Group B: Motor Cortex StimulationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
From enrollment to the end of treatment at 22 days
2

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.

Time frame
Study enrollment to end of study at 22 days
3

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.

Time frame
Upon enrollment to 22 days
4

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).

Time frame
Upon enrollment to 22 days

Secondary outcomes

1

Pain Catastrophizing Scale

Measures of catastrophic thinking related to pain will be measured with the Pain Catastrophizing Scale (PCS). The PCS is a 13-item self-report questionnaire widely used self-report tool that measures catastrophic thinking related to pain. It assesses three domains-rumination, magnification, and helplessness based on thoughts and feelings about pain, even when not currently in pain. Total scores range from 0-52, where higher scores indicate greater catastrophizing; a total score above 30 indicates a clinically significant level.

Time frame
Upon enrollment to 22 days
2

Impulsive Behavior Scale

Measures of impulsivity will be measured with the UPPS Inventory. The UPPS is a 59-item self-report questionnaire developed to assess four distinct facets of impulsivity: urgency, lack of premeditation, lack of perseverance, and sensation-seeking. Grounded in the Five Factor Model of personality, it integrates items from multiple established impulsivity scales. Responses are rated on a 4-point Likert scale, with higher scores indicating greater impulsive tendencies. Higher scores indicate greater impulsivity, with subscale minimums/maximums ranging from 4 to 16.

Time frame
Upon enrollment to 22 days
3

Brief Pain Inventory

Daily pain severity will be measured with the Brief Pain Inventory (BPI). The BPI is a self-report questionnaire assessing pain severity and its interference with daily functioning. Respondents rate pain intensity (worst, least, average, current) and interference with activities (e.g., mood, work, sleep) on 0-10 scales. Scores yield severity and interference indices, with higher values indicating greater pain impact. The BPI demonstrates strong reliability, validity, and sensitivity across diverse clinical populations.

Time frame
Upon enrollment to 22 days.
4

Electromyography Recording

High density electromyography (HD-EMG) will be recorded in response to transcranial electrical stimulation (TES) throughout the study period. HD-EMG and/or bipolar EMG electrodes will be placed on the participant's limbs or torso muscles to record resulting activity. EMG activity is recorded in microvolts and resulting motor evoked potentials (MEPs) will be quantified in terms of changes in amplitude (root mean square ratio), shape, and latency.

Time frame
Upon enrollment to 22 days

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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