None listed
Conditions
Brief summary
This study aims to evaluate the safety, feasibility, and acceptability of combining cognitive training (CT) with intermittent theta burst stimulation (iTBS), a safe and non-invasive form of brain stimulation, in older adults with mild cognitive impairment (MCI). MCI is a condition involving mild memory and thinking difficulties that can increase the risk of developing dementia. Participants will be randomly allocated to one of two groups: CT combined with active iTBS, or CT combined with sham (inactive) iTBS. Both groups receive the same 10-week cognitive training program. iTBS is delivered over 5 consecutive days at the start of the study, targeting a brain region involved in memory and learning. As this is a feasibility pilot study, the primary aim is not to test whether the intervention works, but to assess whether it can be safely and practically delivered, including how well participants can be recruited, how many complete the program, and how acceptable they find it. Any changes in memory, thinking, brain activity, and well-being will also be measured as exploratory outcomes to inform the design of a future larger trial. We hypothesise that the combined CT and iTBS program will be feasible, acceptable, and safe in people with MCI.
Interventions
Computerised Cognitive Training (CCT) + Intermittent Theta Burst Stimulation (iTBS): Week 1 – Combined Delivery (In-Person): Over 5 consecutive weekdays, participants attend in-person sessions at Western Sydney University (NICM or Campbelltown campus). Each daily session is approximately 3 hours in total, comprising: iTBS: 5 sessions per day (10 minutes apart), targeting the left dorsolateral prefrontal cortex (DLPFC), for a total of 25 sessions (15,000 pulses). • Delivered using MagPro X100 or MagStim Super Rapid2 Plus1 stimulators. • Coil positioned with neuronavigation (Brainsight, BeamF3). • Stimulation parameters: 3 pulses at 50 Hz, repeated at 5 Hz, delivered in 2-second trains with 8-second inter-train intervals, at 75% resting motor threshold (RMT), adjusted daily. • Delivered by the chief investigator (an occupational therapist/neuroscientist with 1 year of intensive TMS training), under the ongoing supervision of a neuroscientist and TMS expert. • Rest: 20-minute rest period following iTBS. CCT (In-Person): 1-hour one-to-one session, delivered on a computer by the same occupational therapist (chief investigator) with extensive experience in cognitive training. • Format: Computer-based interactive tasks; one-on-one delivery with real-time guidance. • Example exercises from the iCog.X Boost program: visual memory grids, auditory memory tasks, divided attention dual-tasks, logical reasoning exercises, and problem-solving strategy exercises. These sessions focus on teaching participants cognitive strategies that will later be applied in the online training. • Adherence monitoring: Daily attendance checklists for both iTBS and CCT are maintained by the research team. Weeks 2–10 – CCT Only (Online): Participants continue the CCT intervention independently online for an additional 9 weeks. • Delivery: ~1 hour per week (9 sessions), via a secure, university-hosted platform (developed in Flask Python and hosted through pythonanywhere). • Training Content: Same training modules as in-person, ensuring continuity. The online mode includes interactive activities, instructional videos, images, and practice questions. Unlike the in-person sessions, these modules are self-paced, with automated feedback and performance adaptation. • Psychoeducation: Two small-group sessions (each ~2 hours: 90 minutes content + 30 minutes group discussion) are delivered via Zoom by a registered psychologist. These occur during the online training phase, specifically, one session in Week 5 and the second in Week 8 of the 10-week intervention period. Content includes videos, slides, interactive exercises, and collaborative discussion of cognitive strategies. • Home-Based Tasks: Weekly assignments encourage transfer of skills into daily life. Examples include: • Memory challenges (recall a shopping list or recipe ingredients without notes). • Strategy-based activities (chunking information when learning new material). • Reflection questions or short quizzes on strategy use. • Adherence Monitoring: Online session completion is automatically logged by the platform. Attendance at psychoeducation sessions is recorded, and reminders/support are provided via phone and email. Sham iTBS Condition: Participants receive the same cognitive training protocol as the active intervention group. Sham stimulation is delivered using the same figure-of-eight coil rotated 180°, which substantially reduces magnetic field penetration while preserving the auditory and tactile sensations of active stimulation. Sham iTBS is administered over 5 consecutive days (3 pulses at 50 Hz, repeated at 5 Hz, delivered in 2-second trains with 8-second inter-train intervals, 5 sessions/day for 5 days, total 25 sessions). This method maintains blinding integrity and has been validated in previous TMS trials.
Sponsors
Study design
Eligibility
Inclusion criteria
• Aged 55–85 years • Clinical characterisation of Mild Cognitive Impairment (MCI) based on Winblad criteria, including: • Subjective cognitive complaints via semi-structured clinical interview • Objective cognitive decline: • Memory Alteration Test (M@T) score greater than or equal to 37, OR • Performance 1.0–1.5 standard deviations below age-adjusted norms and/or estimated premorbid ability (Test of Premorbid Functioning [ToPF]) • Preserved or minimal instrumental activities of daily living (iADL) impairment, based on HBA-FAQ and study neuropsychologist discretion • Right-handed (Edinburgh Handedness Inventory) • Fluent in English (reading, writing, speaking) • Normal or corrected-to-normal vision and hearing • Access to a personal desktop or laptop with full internet access
Exclusion criteria
• Prior exposure to transcranial magnetic stimulation (TMS) within the past 12 months • Memory Alteration Test (M@T) score 30 minutes, retrograde amnesia, post-traumatic concussion syndrome, or structural brain abnormalities