Transcranial Electrical Stimulation for Noninvasive Study of Menopausal/Perimenopausal Symptoms
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About
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.
Full 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.
Enrollment
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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.
Trial design
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Allocation
Interventional model
Masking
50 participants in 2 patient groups
Trial contacts and locations
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Central trial contact
Pulkit Grover, PhD
Data sourced from clinicaltrials.gov
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