Transcranial Magnetic Stimulation for Mild Cognitive Impairment (TMS-AD Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Duke University
No Placebo Group
Approved in 3 jurisdictions
Trial Summary
What is the purpose of this trial?The proposed research will use closed-loop transcranial magnetic stimulation (TMS) based on individualized brain networks to establish parameters that can reliably control brain states. This will be tested in healthy aging and mild cognitive impairment (MCI) cohorts. The investigators will study network activation and neural oscillatory mechanisms underlying the network that regulates working memory and then target this network using closed-loop TMS to the Prefrontal Cortex. Investigators will measure the impact of TMS on working memory performance and task-based neural activity. The project will use brain stimulation and network modeling techniques to enhance working memory in healthy older adults and MCI and will demonstrate the value of closed-loop, network-guided TMS for future clinical applications.
Is transcranial magnetic stimulation (TMS) safe for humans?
Transcranial magnetic stimulation (TMS) is generally considered safe, with guidelines established to minimize risks. Some mild side effects like headaches and nausea have been reported, and there is a rare risk of seizures, but serious adverse effects are uncommon.
1241011What data supports the effectiveness of the treatment Transcranial Magnetic Stimulation for Mild Cognitive Impairment?
Research shows that repetitive Transcranial Magnetic Stimulation (rTMS) can improve cognitive function in people with mild cognitive impairment (MCI). Studies have found that rTMS can enhance memory performance and cognitive abilities, with some improvements lasting for weeks after treatment.
35689How does the treatment Transcranial Magnetic Stimulation differ from other treatments for mild cognitive impairment?
Transcranial Magnetic Stimulation (rTMS) is unique because it uses magnetic fields to stimulate specific areas of the brain, potentially enhancing cognitive function in patients with mild cognitive impairment. Unlike traditional drug treatments, rTMS is non-invasive and can improve brain activity and memory performance by targeting cognitive-related brain areas.
36789Will I have to stop taking my current medications?
The trial requires that you stop taking any medications known to lower the seizure threshold or affect working memory.
Eligibility Criteria
This trial is for English-speaking adults who are experiencing mild cognitive impairment or general cognitive decline. Participants must be willing to provide consent. It aims to help those noticing memory challenges associated with aging.Participant Groups
The study tests a technique called closed-loop transcranial magnetic stimulation (TMS), targeting the Prefrontal Cortex, to improve working memory in older adults and those with mild cognitive impairment by modulating brain networks.
3Treatment groups
Experimental Treatment
Placebo Group
Group I: TMS-RandomizedExperimental Treatment1 Intervention
Three different closed-loop conditions will be tested, each triggered by the presence of a sustained period of alpha-band power. In the first condition, arrhythmic TMS trains with a stochastic (randomized) inter-pulse interval, will be used to disrupt cortical alpha oscillations and thus be expected to enhance memory performance.
Group II: TMS-OrderedExperimental Treatment1 Intervention
Three different closed-loop conditions will be tested, each triggered by the presence of a sustained period of alpha-band power. In the second condition, rhythmic (ordered) alpha-frequency TMS trains, with the expectation that this alpha stimulation will further entrain a synchronization during the task and thereby worsen memory performance.
Group III: TMS-ShamPlacebo Group1 Intervention
Three different closed-loop conditions will be tested, each triggered by the presence of a sustained period of alpha-band power. In a third condition, sham stimulation will be delivered at the same randomized inter-pulse interval, but with no TMS delivered to the brain.
Transcranial Magnetic Stimulation is already approved in United States, Canada, European Union for the following indications:
🇺🇸 Approved in United States as Transcranial Magnetic Stimulation for:
- Major Depressive Disorder
- Obsessive Compulsive Disorder
🇨🇦 Approved in Canada as Transcranial Magnetic Stimulation for:
- Major Depressive Disorder
🇪🇺 Approved in European Union as Transcranial Magnetic Stimulation for:
- Major Depressive Disorder
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Duke University HospitalDurham, NC
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Who is running the clinical trial?
Duke UniversityLead Sponsor
National Institute on Aging (NIA)Collaborator
References
[Repetitive transcranial magnetic stimulation. Possibilities, limits and safety aspects]. [2019]Repetitive magnetic stimulation (rTMS) is a non-invasive, painless method to induce transient activation in circumscript regions of the human cortex. In contrast to TMS with single pulses rTMS allows a more effective stimulation of association cortex and temporary interference with the proper functioning of stimulated areas. Possible applications for examination of the functional anatomy of language lateralisation, memory functions and visual perception are discussed. Possible therapeutic for movement disorders and depression are discussed. On the basis of theoretical considerations and current experience rTMS induced epileptogenic effects are discussed and safety recommendations are given.
Side effects of repetitive transcranial magnetic stimulation. [2005]The side effects of repetitive transcranial magnetic stimulation are largely unexplored and the limits of safe exposure have not been determined except as regards the acute production of seizures. Although tissue damage is unlikely, however, cognitive and other adverse effects have been observed and the possibility of unintended long-term changes in brain function are theoretically possible.
Brain stimulation improves associative memory in an individual with amnestic mild cognitive impairment. [2016]In patients with cognitive deficits, brain stimulation has been shown to restore cognition ( Miniussi et al., 2008 , Brain Stimulation, 1, 326). The aim of this study was to assess whether repetitive Transcranial Magnetic Stimulation (rTMS) could improve memory performance in an individual with amnestic Mild Cognitive Impairment (aMCI). Stimulation of the left parietal cortex increased accuracy in an association memory task, and this improvement was still significant 24 weeks after stimulation began. These findings indicate that rTMS to the left parietal cortex improved memory performance in aMCI.
Comparative incidence rates of mild adverse effects to transcranial magnetic stimulation. [2022]Past research has largely neglected to investigate mild adverse effects (MAEs) to transcranial magnetic stimulation (TMS), including headache and nausea. Here we explored the relationship between MAEs, participant characteristics (age and gender) and protocol parameters, including mode of application, coil geometry, stimulated brain region, TMS frequency, TMS intensity, and active vs. sham stimulation.
Effects of repetitive transcranial magnetic stimulation on improvement of cognition in elderly patients with cognitive impairment: a systematic review and meta-analysis. [2018]This systematic review and meta-analysis aimed to examine the effects of repetitive transcranial magnetic stimulation (rTMS) on cognitive function in older patients with cognitive impairment.
Repetitive Transcranial Magnetic Stimulation Induced Hypoconnectivity Within the Default Mode Network Yields Cognitive Improvements in Amnestic Mild Cognitive Impairment: A Randomized Controlled Study. [2020]Repetitive transcranial magnetic stimulation (rTMS) is thought to be effective in alleviating cognitive symptoms in patients with amnestic mild cognitive impairment (aMCI), but the mechanisms related to network modification are poorly understood.
Neuroimaging mechanisms of high-frequency repetitive transcranial magnetic stimulation for treatment of amnestic mild cognitive impairment: a double-blind randomized sham-controlled trial. [2021]Individuals with amnestic mild cognitive impairment (aMCI) have a high risk of developing Alzheimer's disease. Although repetitive transcranial magnetic stimulation (rTMS) is considered a potentially effective treatment for cognitive impairment in patients with aMCI, the neuroimaging mechanisms are poorly understood. Therefore, we performed a double-blind randomized sham-controlled trial in which rTMS was applied to the left dorsolateral prefrontal cortex of aMCI patients recruited from a community near the Third Hospital Affiliated to Sun Yat-sen University, China. Twenty-four patients with aMCI were randomly assigned to receive true rTMS (treatment group, n = 12, 6 men and 6 women; age 65.08 ± 4.89 years) or sham stimulation (sham group, n = 12, 5 men and 7 women; age 64.67 ± 4.77 years). rTMS parameters included a stimulation frequency of 10 Hz, stimulation duration of 2 seconds, stimulation interval of 8 seconds, 20 repetitions at 80% of the motor threshold, and 400 pulses per session. rTMS/sham stimulation was performed five times per week over a period of 4 consecutive weeks. Our results showed that compared with baseline, Montreal Cognitive Assessment scores were significantly increased and the value of the amplitude of low-frequency fluctuation (ALFF) was significantly increased at the end of treatment and 1 month after treatment. Compared with the sham group, the ALFF values in the right inferior frontal gyrus, triangular part of the inferior frontal gyrus, right precuneus, left angular gyrus, and right supramarginal gyrus were significantly increased, and the ALFF values in the right superior frontal gyrus were significantly decreased in the treatment group. These findings suggest that high-frequency rTMS can effectively improve cognitive function in aMCI patients and alter spontaneous brain activity in cognitive-related brain areas. This study was approved by the Ethics Committee of Shenzhen Baoan Hospital of Southern Medical University, China (approval No. BYL20190901) on September 3, 2019, and registered in the Chinese Clinical Trials Registry (registration No. ChiCTR1900028180) on December 14, 2019.
Effect of transcranial magnetic stimulation as an enhancer of cognitive stimulation sessions on mild cognitive impairment: Preliminary results. [2021]Mild cognitive impairment (MCI) is a state between normal cognition and dementia. Currently, there is little evidence of repetitive Transcranial Magnetic Stimulation (rTMS) as an enhancing tool for Cognitive Stimulation (CS) on MCI. The importance of this study consists in its assessment of the enhancing effect of rTMS on CS in 22 MCI patients randomized and divided into two group: active (AG) and sham (SG). Diagnoses and assessments were determined during 30 sessions over a 10-week period by Montreal Cognitive Assessment (MoCA) and Neuropsí test. Results were statistically significant in the intergroup analysis with MoCA and intragroup only for AG.
Integration of Virtual Reality into Transcranial Magnetic Stimulation Improves Cognitive Function in Patients with Parkinson's Disease with Cognitive Impairment: A Proof-of-Concept Study. [2022]Emerging evidence has indicated the positive effects of repetitive transcranial magnetic stimulation (rTMS) on patients with Parkinson's disease (PD) for the treatment of mild cognitive impairment (MCI).
Safety Review for Clinical Application of Repetitive Transcranial Magnetic Stimulation. [2023]Studies using repetitive transcranial magnetic stimulation (rTMS) in healthy individuals and those with neuropsychiatric diseases have rapidly increased since the 1990s, due to the potential of rTMS to modulate the cortical excitability in the brain depending on the stimulation parameters; therefore, the safety considerations for rTMS use are expected to become more important. Wassermann published the first safety guidelines for rTMS from the consensus conference held in 1996, and Rossi and colleague then published the second safety guidelines from the multidisciplinary consensus meeting held in Siena, Italy in 2008, on behalf of the International Federation of Clinical Neurophysiology. More than 10 years after the second guidelines, the updated third safety guidelines were recently published in 2021. The general safety guidelines for conventional rTMS have not substantially changed. Because the most frequently used rTMS protocol is conventional (low- and high-frequency) rTMS in research and clinical settings, we focus on reviewing safety issues when applying conventional rTMS with a focal cortical stimulation coil. The following issues will be covered: 1) possible adverse events induced by rTMS; 2) checklists to screen for any precautions and risks before rTMS; 3) safety considerations for dosing conventional rTMS; and 4) safety considerations for using rTMS in stroke and traumatic brain injury.
The repetitive transcranial magnetic stimulation in Alzheimer's disease patients with behavioral and psychological symptoms of dementia: a case report. [2023]Repetitive transcranial magnetic stimulation is a noninvasive intervention, can significantly reduce behavioral and psychological symptoms and cognitive impairment in AD patients. Only few cases have been reported the adverse reactions after the treatment. This report described the different adverse reactions after repetitive transcranial magnetic stimulation with different parameters.