Repetitive Transcranial Magnetic Stimulation for Mild Cognitive Impairment

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Arizona

Disqualifiers: Stroke, Head injuries, Multiple sclerosis, others

Trial Summary

What is the purpose of this trial?

The ultimate goal of this study is to develop non-invasive, painless repetitive transcranial magnetic stimulation (rTMS) protocols to prevent cognitive decline in patients with mild cognitive impairment (MCI) and cognitively normal individuals at high risk of developing Alzheimer's disease (AD). Currently, 1 in 9 adults over the age of 65 have AD, which currently totals more than 5 million Americans and this number is expected to rise as high as 16 million by 2050. MCI is a clinical syndrome that represents the gray area between healthy aging and dementia. Those with amnestic MCI (aMCI) have memory problems more severe than normal for their age and education, but their symptoms are not as severe as those of people with AD. Patients with aMCI are at high risk for AD. Notably, roughly half of those with MCI will continue to progress and convert to clinical dementia within 3 years. Alternatively, it is also worthwhile to study cognitively healthy older adults who carry genes that may increase the risk of AD. The frequency of the human APOE gene ε4 allele increases in patients with AD and the ε4 allele is also associated with an earlier age of disease onset. Currently, there are no known therapies that can effectively modify the progression and hallmark symptoms of AD. Therefore, it is crucial to provide an early intervention in patients with aMCI to delay or prevent the progression to AD. More specifically, this project has two specific aims: 1. To plan personalized non-invasive brain stimulation location by brain Imaging with Magnetic Resonance Imaging (MRI) in Mild Cognitive Impairment (MCI) 2. To identify potential personalized cognitive enhancement strategy (such as dosage or patterns) of Transcranial Magnetic Stimulation (TMS) in MCI. Techniques to artificially and precisely stimulate brain tissue are increasingly recognized as valuable tools both in clinical practice and in cognitive neuroscience studies among healthy individuals and people with clinical conditions. With these practices, researchers can safely stimulate specific regions of the brain to explore causal relationships that comprise the brain's circuitry and modulate behavior.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Repetitive 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, as seen in studies where it enhanced memory and cognitive test scores. It has also been effective in improving cognitive function in patients with Parkinson's disease and post-stroke cognitive impairment.

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How does the treatment repetitive transcranial magnetic stimulation (rTMS) differ from other treatments for mild cognitive impairment?

Repetitive transcranial magnetic stimulation (rTMS) is unique because it is a noninvasive treatment that uses magnetic fields to stimulate specific areas of the brain, potentially enhancing cognitive function in patients with mild cognitive impairment. Unlike other treatments, rTMS can alter brain activity in cognitive-related areas, which may lead to improvements in cognitive function.

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Eligibility Criteria

This trial is for English-speaking individuals aged 50-80 with mild cognitive impairment (MCI), who can attend daily sessions for 4 weeks, and haven't been in another study recently. They should have certain scores on cognitive tests like the MMSE or MoCA, be right-handed, and not have dementia.

Inclusion Criteria

You must be able to speak English.

You have not participated in another research study that involves receiving treatment within the past 6 months.

You have difficulty with thinking and memory as shown by certain tests, such as the MMSE or MoCA, with scores between 24-27 or 18-26, respectively. Or, you have a Clinical Dementia Rating Scale score of 0.5.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Intervention

Participants receive 30 intervention sessions of TMS across three different protocols, with MRI and cognitive tasks before and after each protocol

3 months

30 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including brain imaging and neuropsychological assessments

3 months

2 visits (in-person)

Participant Groups

The study aims to prevent cognitive decline using repetitive transcranial magnetic stimulation (rTMS). It involves personalized brain stimulation guided by MRI imaging to enhance memory and delay Alzheimer's disease progression in those at high risk.

Group I: Inhibitory TBS Experimental Treatment 1 Intervention

Inhibitory TBS

Group II: Excitatory TBS Experimental Treatment 1 Intervention

Excitatory TBS

Group III: Sham TBS Placebo Group 1 Intervention

Sham TBS

TBS is already approved in United States for the following indications:

🇺🇸 Approved in United States as TMS for:

• Major Depressive Disorder

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Bioscience Research Laboratory Tucson, AZ

Who Is Running the Clinical Trial?

University of Arizona Lead Sponsor

National Institute on Aging (NIA) Collaborator

References

1. Ireland pubmed.ncbi.nlm.nih.gov

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.

2. Netherlands pubmed.ncbi.nlm.nih.gov

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).

3. India pubmed.ncbi.nlm.nih.gov

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.

4. Switzerland pubmed.ncbi.nlm.nih.gov

Cerebral activity manipulation of low-frequency repetitive transcranial magnetic stimulation in post-stroke patients with cognitive impairment. [2022] The aim of this study was to evaluate the therapeutic effect of low-frequency repetitive transcranial magnetic stimulation (rTMS) on post-stroke cognitive impairment (PSCI).

5. England pubmed.ncbi.nlm.nih.gov

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.

6. Netherlands pubmed.ncbi.nlm.nih.gov

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.

7. England pubmed.ncbi.nlm.nih.gov

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.