Transcranial Electrical Stimulation for Noninvasive Study of Menopausal/Perimenopausal Symptoms
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Carnegie Mellon University
- Enrollment
- 50
- Primary Endpoint
- Depression
Study Overview
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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Device Feasibility
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 40 Years to 60 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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).
Exclusion Criteria
- •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.
Arms & Interventions
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.
Intervention: Transcranial Electrical Stimulation (Device)
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.
Intervention: Transcranial Electrical Stimulation (Device)
Outcomes
Primary Outcomes
Depression
Time Frame: From enrollment to the end of treatment at 22 days
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.
Sleep Quality
Time Frame: Study enrollment to end of study at 22 days
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.
Menopause Quality of Life
Time Frame: Upon enrollment to 22 days
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.
Center for Epidemiological Studies-Depression Inventory (CES-D)
Time Frame: Upon enrollment to 22 days
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).
Numerical Rating Scale
Time Frame: Upon enrollment to 22 days
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.
Secondary Outcomes
- 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)
- Functional Near-Infrared Spectroscopy(Upon enrollment to 22 days)
- Electroencephalogram(Upon enrollment to 22 days)
- Heat Pain Thresholding(Upon enrollment to 22 days)
- Pressure Pain Thresholding(Upon enrollment to 22 days)
Investigators
Pulkit Grover
Professor
Carnegie Mellon University