80 Participants NeededMy employer runs this trial

rTMS for Cognitive Impairment

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Overseen ByJoy Shihui Meng, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: San Francisco Neurology and Sleep Center
Must be taking: Cognitive enhancers
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether repetitive transcranial magnetic stimulation (rTMS) can improve thinking and memory in adults with mild to moderate cognitive issues, such as mild dementia. Participants will use the EXOMIND™ device for six sessions over three weeks, targeting specific brain areas. The study aims to determine if this treatment can enhance cognitive function over three months. Individuals experiencing noticeable memory and thinking difficulties, who have been stable on cognitive medications for at least four weeks, might be suitable candidates. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could enhance cognitive health.

Do I need to stop my current medications for the trial?

You need to be on stable doses of any cognitive-enhancing medications for at least 4 weeks before the trial and should not change them during the study. If you are taking medications that lower the seizure threshold, you may need to stop them, as they are not allowed in the trial.

What prior data suggests that the rTMS technique is safe for cognitive impairment?

Research has shown that the EXOMIND™ device (BTL-699-2), used for repetitive transcranial magnetic stimulation (rTMS), is generally safe and well-tolerated. Studies have found that this device can improve mental well-being without causing major side effects. For example, research on similar devices indicates that rTMS does not lead to seizures or memory loss, unlike some other brain stimulation methods.

In another study, participants using the BTL-699-2 device reported better sleep quality and lower stress levels, with no significant negative effects. More broadly, rTMS has proven effective and safe for conditions like obsessive-compulsive disorder and depression, where it already has FDA approval. This suggests the treatment might also be well-tolerated for cognitive impairment.

Overall, while specific data on cognitive impairment is limited, existing research provides reassuring evidence about the device's safety in humans.12345

Why are researchers excited about this trial?

Unlike traditional treatments for cognitive impairment, such as medications and cognitive therapy, the EXOMIND™ device uses repetitive transcranial magnetic stimulation (rTMS) to directly target the brain. This method involves delivering magnetic pulses to the left dorsolateral prefrontal cortex, which is thought to play a role in cognitive function. Researchers are excited about this treatment because it offers a non-invasive approach that may enhance cognitive abilities more quickly and effectively than current options. Additionally, the personalized adjustment of stimulation based on the individual's motor threshold could lead to more tailored and potentially more effective outcomes.

What evidence suggests that the EXOMIND™ device is effective for cognitive impairment?

Studies have shown that repetitive transcranial magnetic stimulation (rTMS) can improve thinking and memory in some individuals. rTMS is particularly effective for mental health conditions like depression, which can sometimes be linked to cognitive difficulties. Research indicates that real rTMS treatments have significantly enhanced thinking abilities in multiple studies involving hundreds of participants. In this trial, participants will receive rTMS using the EXOMIND™ device, tested for boosting mental well-being, though no published evidence yet specifically addresses its effect on thinking problems. rTMS stimulates nerve cells in the brain, especially in areas related to thinking and mood.12467

Are You a Good Fit for This Trial?

This trial is for adults aged 50 to 90 with mild to moderate cognitive impairment or early dementia. Participants must have a MoCA score between 10 and 25, be able to attend all visits, have stable medication doses, sufficient vision and hearing, and a caregiver who can provide information about their condition.

Inclusion Criteria

I am between 50 and 90 years old.
I am able and willing to attend all study visits.
* Presence of a reliable study partner or caregiver who can provide information about the participant's cognitive and functional status.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

Treatment

Participants receive 6 sessions of high-frequency rTMS targeting the left dorsolateral prefrontal cortex over approximately 3 weeks

3 weeks
6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 1-month and 3-month follow-up

3 months
2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • EXOMIND™ device (BTL-699-2)

Trial Overview

The study tests whether six sessions of repetitive transcranial magnetic stimulation (rTMS) over three weeks can improve thinking and memory in people with cognitive decline. All participants receive rTMS using the EXOMIND device; changes in cognition are measured up to three months after treatment.

How Is the Trial Designed?

1

Treatment groups

Active Control

Group I: rTMS TreatmentActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

San Francisco Neurology and Sleep Center

Lead Sponsor

Citations

A Novel Breakthrough in Transcranial Magnetic Stimulation ...

Conclusion: The study results indicate ExoTMS™ treatments as a promising approach in enhancing mental well-being, showing efficacy across all WEMWBS well-being ...

ExoTMS transcranial magnetic stimulation for the reduction of ...

This article aims to evaluate the efficacy and safety of a novel TMS device with ExoTMS™ Technology for alleviating BE symptoms. Methods.

EXOMIND (BTL-699-2) for the Improvement of Sleep ...

The goal of this clinical trial is to evaluate whether the treatment with BTL-699-2 device is able to improve sleep quality and reduce stress in adults ...

Clinical Research Trial Listing ( Sleep

Over the years, rTMS has shown promise in treating various mental health conditions, including depression, obsessive-compulsive disorder (OCD) ...

Statement of Clarification: Exomind in Vogue and Other Media ...

In the United States, TMS devices are FDA-cleared for major depressive disorder, depression with anxious features, obsessive-compulsive disorder ...

Effects of Accelerated rTMS on Cognitive Function

The purpose of this study is to evaluate the efficacy and tolerability of repetitive transcranial magnetic stimulation (rTMS) delivered via the ...

BTL-699-2 for Sleep Quality · Info for Participants

Research has shown that transcranial magnetic stimulation (TMS), as used in the BTL-699-2 device, is generally safe for healthy individuals and those with ...