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Phase 2 Clinical Trial Conducted to Assess the Effectiveness of Faster Transcranial Magnetic Stimulation (iTMS) in Improving Mild Cognitive Impairment (MCI)

Clinical Trial Investigating Faster Transcranial Magnetic Stimulation to Improve Mild Cognitive Impairment

Seoul Asan Hospital Provides Source

A clinical trial is currently taking place in the United States to explore whether faster transcranial magnetic stimulation (iTMS) can enhance mild cognitive impairment (MCI), an intermediate stage that may lead to dementia.

TMS involves the placement of a large electromagnetic coil on the scalp to generate a magnetic field within the brain tissue by passing an electric current through the brain’s nerve cells. It is commonly used to treat severe depression that does not respond well to medication and to evaluate the brain’s ability to transmit electrical signals across neural circuits.

Mild cognitive impairment refers to a condition where an individual’s cognitive functioning, such as memory, is below par compared to their same-aged peers, but not to the extent of interfering with daily life. However, it is known that mild cognitive impairment often progresses to dementia.

According to EurekAlert, the American Association for the Advancement of Science’s science news website, Professor Andreana Benitez from the University of South Carolina School of Medicine’s research team in neuropsychology is leading this phase 2 clinical trial after the initial findings were reported on the 29th.

The research team purposely selected elderly individuals with various causes of MCI in order to investigate the different types present. MCI can arise from multiple factors including Alzheimer’s disease, as well as age-related changes in the brain resembling those caused by strokes.

Given the prevalence of depression among the elderly, especially those with MCI, TMS is already approved by the US Food and Drug Administration (FDA) for depression treatment in the left hemisphere of the brain.

In this particular clinical trial, iTMS will be used, which delivers more stimulation pulses to the brain within a shorter time frame than conventional TMS. While regular TMS lasts between 20 to 30 minutes each session, iTMS stops after 3 minutes while maintaining the same efficacy.

Due to its concise treatment duration, iTMS can be administered multiple times a day. For instance, a once-daily regimen of regular TMS that typically lasts 4 to 6 weeks can be shortened to approximately 6 days.

Phase 1 clinical trials have already confirmed the safety and tolerability of iTMS. The research team now aims to determine the optimal dosage required to improve depression and memory decline in elderly individuals with MCI through this phase 2 trial. As part of the process, some trial participants will receive very weak or no magnetic stimulation to ascertain the exact dose required.

Additionally, the research team plans to employ Fitbit, a smartwatch worn on the wrist, to monitor the impact of iTMS treatment on the daily lives of the participants. This method allows for an accurate understanding of their routines without relying solely on direct self-reporting.

The primary objective of this phase 2 clinical trial is to investigate whether iTMS can effectively alleviate MCI and depression. Upon confirmation of the appropriate iTMS dosage, a comprehensive phase 3 trial will be conducted, targeting a larger population of individuals with MCI to further evaluate the treatment’s efficacy.

Contact: skhan@yna.co.kr

Execution time2023-07-31 08:57

transcranial magnetic stimulation

[출처: 서울아산병원]

(Seoul = Yonhap News) Reporter Han Seong-gan = A clinical trial is being conducted in the United States to determine whether mild cognitive impairment (MCI), an intermediate stage that can lead to dementia, can be improved with faster transcranial magnetic stimulation ( iTMS ).

TMS is a method where a large electromagnetic coil is placed on the scalp and an electric current is passed through the brain to stimulate the nerve cells of the brain and generate a magnetic field in the brain tissue. It is used to treat severe depression that does not work well with medication. It is also used to measure the ability to transmit electrical signals to various neural circuits in the brain.

Mild cognitive impairment is a case where cognitive functioning, such as memory, is below that of other elderly people of the same age, and is not to the extent that it interferes with everyday life. However, mild cognitive impairment is likely to progress to dementia.

According to EurekAlert, the science news website of the American Association for the Advancement of Science (AAAS), this clinical trial, conducted by a research team led by Professor Andreana Benitez of Neuropsychology at the University of South Carolina School of Medicine, is being conducted as a phase 2 clinical trial following the first step reported on the 29th.

The research team selected elderly people with different types of MCI caused by as many causes as possible. MCI can occur for a number of reasons. It can be due to Alzheimer’s disease, but it can also be due to stroke-like changes in the brain during the aging process.

Depression is common among the elderly. This is especially true for older people with MCI.

TMS, used in the left hemisphere of the brain, is already approved by the US Food and Drug Administration (FDA) to treat depression.

iTMS, which will be used in this clinical trial, sends more stimulation pulses to the brain in a shorter time than normal TMS. Unlike regular TMS, magnetic stimulation is applied for 20 to 30 minutes at a time, but it stops in 3 minutes, but the effect remains the same.

Because the treatment time is so short, it can be done several times a day. For example, the once-daily treatment with regular TMS, which used to take 4 to 6 weeks, is shortened to about 6 days.

In phase 1 clinical trials that have already been conducted, iTMS has been found to be safe and well tolerated.

The research team aims to find out what dose of iTMS is needed to improve depression and memory decline in elderly people with MCI, through a phase 2 clinical trial. To determine the exact dose, some of the clinical trial participants received magnetic stimulation very weak or no magnetic stimulation, the research team said.

The research team will also use Fitbit, a smart watch worn on the wrist, to track how the iTMS treatment affects the daily lives of the trial participants.

Rather than asking the participants directly, this method helps to accurately understand their daily life.

The most important primary purpose of the phase 2 clinical trial is whether iTMS can help improve MCI and depression.

Once the correct dose of iTMS is confirmed, a full-scale phase 3 clinical trial will be conducted to target more MCI patients to test the effect of iTMS.

skhan@yna.co.kr

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