Brain Stimulation + Cognitive Training for Mild Cognitive Impairment
(RISE pilot Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a treatment combining brain stimulation and cognitive training for individuals with mild cognitive impairment (MCI). The brain stimulation, known as accelerated intermittent theta burst stimulation (iTBS), is non-invasive and aims to enhance memory and thinking skills. Participants will also engage in computer-based exercises to improve cognitive function. Individuals with MCI who maintain a stable medication routine and received a diagnosis within the past year may be suitable candidates. The trial aims to determine if this approach effectively improves daily life functions in those with MCI. As an unphased trial, it provides a unique opportunity to explore innovative treatments that could enhance cognitive health.
Do I need to stop my current medications for the trial?
You can continue taking your current medications if they have been at a stable dose for at least 4 weeks before joining the trial. However, daily or weekly use of anticholinergic or sedative medications is not allowed.
What prior data suggests that this combined treatment of iTBS and CCT is safe for people with mild cognitive impairment?
Research has shown that accelerated intermittent theta burst stimulation (iTBS) is usually safe and well-tolerated. One study found that iTBS in people with mild cognitive impairment (MCI) did not cause serious side effects. Another study reported that personalized iTBS was both safe and provided cognitive benefits for patients with mild Alzheimer's disease.
Computerized cognitive training (CCT) is also considered safe. Previous studies highlight that CCT can improve mental abilities in older adults without causing harmful effects. A review of several studies shows that CCT enhances overall brain function in people with MCI.
In summary, research studies have generally shown both iTBS and CCT to be safe. Participants in these studies did not report major safety concerns.12345Why are researchers excited about this trial?
Unlike the standard of care for mild cognitive impairment, which often involves medications like cholinesterase inhibitors, the treatment in question uses a non-invasive brain stimulation technique called accelerated intermittent theta-burst stimulation (iTBS) combined with cognitive training. Researchers are excited about this approach because iTBS is thought to enhance brain plasticity and improve cognitive function more directly by stimulating specific brain regions. Additionally, the treatment's accelerated nature means it could potentially deliver benefits in a shorter time frame compared to traditional therapies. This combination of brain stimulation with cognitive training offers a novel way to potentially boost cognitive abilities in those with mild cognitive impairment.
What evidence suggests that this trial's treatments could be effective for mild cognitive impairment?
Studies have shown that accelerated intermittent theta burst stimulation (iTBS) can improve thinking and memory in people with mild cognitive impairment (MCI). Research indicates that this method may enhance brain function and skills like memory and problem-solving. In this trial, one group of participants will receive iTBS combined with computerized cognitive training (CCT), which has been found to further increase brain activity and the brain's ability to change and adapt. Another group will receive iTBS with sham CCT. CCT alone has also been effective in improving different types of memory and overall brain function in those with MCI. This combination is being explored because both treatments show promise in boosting cognitive abilities.24678
Who Is on the Research Team?
Stephanie Aghamoosa
Principal Investigator
Medical University of South Carolina
Are You a Good Fit for This Trial?
This trial is for people aged 60-85 who have been diagnosed with mild cognitive impairment or a mild neurocognitive disorder in the past year. Participants must speak English, be able to complete assessments, and have a friend or family member willing to help provide information.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive 12 sessions of accelerated iTBS and 11 sessions of either active or sham CCT over 3 treatment days
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Accelerated iTBS
- Computerized Cognitive Training
Trial Overview
The study tests whether combining non-invasive brain stimulation (iTBS) with computerized cognitive training can improve memory and thinking skills in people with mild cognitive problems. All participants get iTBS and are randomly assigned to one of two types of computer-based training.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Participants will receive 12 sessions of accelerated iTBS and 11 sessions of active CCT on each of 3 treatment days.
Participants will receive 12 sessions of accelerated iTBS and 11 sessions of sham CCT on each of 3 treatment days.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Medical University of South Carolina
Lead Sponsor
National Institutes of Health (NIH)
Collaborator
National Institute on Aging (NIA)
Collaborator
Citations
High-dose accelerated intermittent theta burst stimulation ...
Discussion: Personalized aiTBS targeting the DMN or FPN produced clinically meaningful cognitive benefits in mild AD and was safe. Key Words.
Effects of accelerated intermittent theta-burst stimulation ...
These findings suggest that the combined intervention can effectively promote cognitive performance and brain function in aMCI patients.
Accelerated intermittent theta burst stimulation combined ...
Accelerated intermittent theta burst stimulation combined with cognitive training modulates cortical plasticity and brain activation in patients with amnestic ...
Effects of intermittent theta-burst stimulation on cognition and ...
These findings suggest that iTBS can produce delayed cognitive enhancement in individuals with amnestic MCI and very mild AD, while the impact ...
A phase I trial of accelerated intermittent theta burst rTMS for ...
This study provides critical preliminary data to motivate and inform subsequent clinical trials to determine the efficacy of iTBS to improve cognition in ...
A phase I trial of accelerated intermittent theta burst rTMS for ...
There is emerging evidence that suggests accelerated iTBS may benefit cognition in prodromal neurodegenerative disease, but the safety, feasibility, ...
NCT05992831 | Transcranial Magnetic Stimulation for MCI
The goal of this phase II study is to establish the dose-response curves of a safe and clinically feasible non-invasive brain stimulation technique ...
Efficacy and safety of intermittent theta-burst stimulation ... - PMC
The therapeutic efficacy and safety profiles of daily or accelerated intermittent theta-burst stimulation (iTBS) in comparison to daily or ...
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