None listed
Conditions
Brief summary
The aim of this research is to investigate how a potential treatment works for the cognitive and mood symptoms experienced during menopause through a form of non-invasive brain stimulation. Transcranial magnetic stimulation (TMS) is a technique that can alter activation in certain areas of the brain by using magnetic stimulation. This stimulation is non-invasive, which means it is applied to the top of your scalp. The stimulation then travels through the scalp and into the brain. Specific forms of TMS, like intermittent theta-burst stimulation (iTBS) are promising treatments for depression, memory, and thinking. We hypothesise that this may be a promising treatment option that can improve cognition and mood in females going through the late menopause transition. This research will address this evidence-practice gap by testing whether the treatment works.
Interventions
Participants will receive five sessions of intermittent theta burst stimulation (iTBS), a form of transcranial magnetic stimulation (TMS). iTBS is a clinically proven, non-invasive brain stimulation technique that uses electromagnetic fields to activate neural networks in the brain to improve memory, thinking, and mood.
Participants will receive five sessions of iTBS over the left dorsolateral prefrontal cortex (DLPFC), delivered by a qualified and trained PhD candidate. iTBS will be delivere
Participants will receive five sessions of intermittent theta burst stimulation (iTBS), a form of transcranial magnetic stimulation (TMS). iTBS is a clinically proven, non-invasive brain stimulation technique that uses electromagnetic fields to activate neural networks in the brain to improve memory, thinking, and mood. Participants will receive five sessions of iTBS over the left dorsolateral prefrontal cortex (DLPFC), delivered by a qualified and trained PhD candidate. iTBS will be delivered using a MagVenture Transcranial Magnetic Stimulator (MagVenture A/S DK-3520, Denmark). The coil will be held tangential to the scalp with the handle pointed posterolaterally away from the midline at 45 degrees to induce a second phase current in the posterolateral to anteromedial direction. Resting motor threshold (rMT) will be determined as the lowest stimulation intensity at which 5 out of 10 TMS pulses produce a visible response in the first dorsal interossei muscle of the right hand. Stimulation intensity will be delivered at 90 % of the rMT, which will be assessed at the start of each rTMS session. The TMS coil will be positioned through a Brainsight neuro-navigation system (Rogue Research Inc., Canada) based on anatomical landmarks in Montreal Neurological Institute (MNI) space. The coil will be positioned over the left DLPFC in accordance with the BeamF3 algorithm. The left DLPFC was chosen as a core region involved in executive functions, and the U.S. Food and Drug Administration (FDA) has approved rTMS for the treatment of affective disorders targeting the region. Following randomisation, participants will be allocated to one of the two trial arms (sham or active treatment). Active treatment will consist of five sessions of iTBS over five consecutive days. Participants will receive five blocks of iTBS, and each block will be separated by ten minutes. Bursts of three pulses will be delivered at 50 Hz, repeated at 200 millisecond intervals in trains of two seconds. Two-second trains of iTBS will be repeated every ten seconds for a total of 600 pulses per block, and 3000 pulses per session. The intervention will be delivered on Western Sydney University's Westmead Campus. The laboratory is equipped with a Technical Laboratory Officer who will assist the PhD Candidate to monitor tolerability and adherence to the intervention via direct observation. Additionally, the PhD candidate has been receiving training and piloting the use of the TMS device since December 2023, as supervised by a physiotherapist with TMS expertise. All training will be overseen by the supervisory panel and complete by January 2025 (prior to commencing recruitment for the MenoStim Trial).
Sponsors
Western Sydney University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
45 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
• Females undergoing the late menopausal transition stage according to the STRAW criteria as defined by: (a) amenorrhea of 60 days or longer; (b) FSH levels greater than 25 IU/L in a random blood draw; and (c) self-reported vasomotor symptoms, including hot flushes, sleep disturbances, and night sweats. • Females experiencing self-reported subjective cognitive complaints relative to previously normal cognitive status; and self-reported depressive symptoms or anxiety. • Willing to complete all study-related activities for the complete trial including in person assessments and remote follow-ups.
Exclusion criteria
• Individuals who have contraindications to TMS identified using the Transcranial Magnetic Stimulation Adult Safety Screen questionnaire, including: a. History of adverse reactions to rTMS or other forms of non-invasive brain stimulation such as transcranial direct current stimulation (tDCS). b. History of seizures, a medical diagnosis of epilepsy, or family history of epilepsy. c. History of strokes, head injuries with loss of consciousness > 30 min, severe dizzy spells, or frequent or severe headaches and/or migraines. d. Individuals with metal inside the head (outside of the mouth), including shrapnel, surgical clips, or fragments from welding or metal works. e. Individuals with any implanted devices such as cardiac pacemakers, medical pumps, intra-cardiac lines, or Cochlear implants; or with a fine-wire electrode inserted anywhere in their body. • Reproductive age females; females in the late reproductive stage or the early menopausal transition; and postmenopausal females. • Females who have been receiving MHT treatment for less than three months at the time of recruitment or plan to commence MHT treatment during the study duration. • Individuals using neuroactive medications, including anticonvulsants, antidepressants, and anxiolytics. • A diagnosis of neurodegenerative, psychiatric affective, non-affective, or neurological illness. • Significant cognitive impairment as deemed by scoring 17 or less on the Telephone Montreal Cognitive Assessment (T-MoCA). • Current episode of major depression as deemed by scoring 15 or greater according to the Patient Health Questionnaire-9 (PHQ-9). • High dependence on medical care (including medications, particularly drugs with a narrow therapeutic index) due to past or current medical conditions (e.g., cancer) as deemed by the study physician. • Study physician discretion regarding medical status, appropriateness of participation, or concern about intervention adherence. • Individuals who are not willing to follow the study protocol e.g., are not able to attend face-to-face visits or those who plan to move out of the area or travel interstate or overseas within the treatment period. • Individuals who are actively participating in another clinical trial(s). • Individuals who are not proficient in reading and writing in English.
Outcome results
None listed