Clinical trials

Parkinson's disease (PD) is a brain disorder that causes progressive problems with movement, such as slowness, stiffness, tremor, and difficulty walking. Many people with PD also develop problems with thinking and memory. Current medications can help control movement symptoms but often become less effective over time and may cause side effects. There is a need for additional treatment options that can address both movement and thinking difficulties in PD. Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive treatment that uses magnetic pulses delivered to the scalp to stimulate specific areas of the brain. Previous research has shown that rTMS targeting the motor cortex (the part of the brain that controls movement) can improve motor symptoms in people with PD. The purpose of this pilot study is to evaluate whether an accelerated course of rTMS targeting the motor cortex can improve movement and thinking abilities in people with mild to moderate Parkinson's disease. The study will enroll 40 participants aged 50 to 90 years at the San Francisco Neurology and Sleep Center. Participants will receive 6 sessions of rTMS using the EXOMIND™ device, administered twice per week over approximately 3 weeks. Each session delivers high-frequency magnetic stimulation to the motor cortex on both sides of the brain. Participants will be assessed before treatment, at the last treatment session, and at 1-month and 3-month follow-up visits. The primary outcome measure is the change in motor symptoms as measured by the Movement Disorder Society Unified Parkinson's Disease Rating Scale Part III (MDS-UPDRS-III) at 1 month after treatment. Secondary outcomes include additional measures of walking and gait, domain-specific cognitive testing using the Creyos cognitive battery (assessing memory, attention, reasoning, and other thinking skills), the Montreal Cognitive Assessment (MoCA), depression symptoms (PHQ-9), and quality of life (PDQ-39). This is a single-center, open-label study with no placebo or control group. Total participation duration is up to 139 days, including screening, treatment, and follow-up visits.

Chronic insomnia disorder is a common condition in which people have ongoing difficulty falling asleep, staying asleep, or waking too early. It affects about 10-12% of adults and can lead to daytime problems, stress, and other health issues. Current treatments include talk therapy (cognitive behavioral therapy for insomnia) and sleep medications, but medications can have side effects and may not work well over the long term. Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive treatment that uses magnetic pulses applied to the scalp to stimulate specific areas of the brain. It has shown promise in improving sleep quality in people with insomnia by targeting a brain region called the left dorsolateral prefrontal cortex, which plays a role in the overactive brain arousal thought to cause insomnia. The purpose of this study is to find out whether an accelerated course of rTMS using the EXOMIND™ device can improve sleep in adults with chronic insomnia disorder. The study will enroll approximately 70 participants aged 18 to 85 years at a single site in San Francisco. Participants will receive 6 rTMS sessions (3 times per week for 2 weeks). Each session lasts about 25 minutes. The study has three phases: a screening phase (up to 25 days) to confirm eligibility using sleep questionnaires and at-home sleep monitoring, a 2-week open-label treatment phase, and a follow-up phase with visits at 1 month and 3 months after the last treatment session. Total participation lasts up to approximately 139 days. The main goal is to measure whether insomnia severity improves after treatment, using a standard questionnaire called the Insomnia Severity Index (ISI). The study will also measure changes in objective sleep patterns (such as how long it takes to fall asleep, time spent in deep sleep, and total sleep time) recorded by a home sleep monitoring device, as well as changes in sleep quality, stress levels, and overall clinical impression of improvement. This is an open-label pilot study, meaning all participants will receive the rTMS treatment and there is no placebo group. The study does not involve any medications. Participants must not have certain medical conditions, electronic or metal implants in or near the head, untreated sleep apnea, or active serious psychiatric disorders. Participants who are pregnant or breastfeeding cannot take part.

Cognitive impairment, including mild cognitive impairment (MCI) and mild dementia, is a growing public health challenge with limited effective treatment options. Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive neuromodulation technique that has shown promise for improving cognitive function, but most studies have used conventional protocols and relied on global screening tools that may not capture domain-specific changes. The purpose of this study is to evaluate the efficacy and tolerability of repetitive transcranial magnetic stimulation (rTMS) delivered via the EXOMIND™ device (BTL-699-2) for improving cognitive function in adults aged 50 to 90 years with mild to moderate cognitive impairment. The study asks whether a course of 6 rTMS sessions targeting the left dorsolateral prefrontal cortex, administered twice weekly over approximately 3 weeks, can produce meaningful and sustained improvements in global and domain-specific cognitive function over a 3-month follow-up period. This is a single-center, open-label, prospective pilot study enrolling 80 participants with documented cognitive decline (Montreal Cognitive Assessment \[MoCA\] score 10-25). Participants will receive 6 sessions of high frequency rTMS (6,300 pulses per session at alternating frequencies of 12, 15, and 18 Hz) over approximately 3 weeks. The primary outcome is the change from baseline in MoCA score at 1-month follow-up. Secondary outcomes include changes in MoCA score at post-treatment and 3-month follow-up, changes in domain-specific cognitive measures (visual spatial working memory, episodic memory, deductive reasoning, mental rotation, verbal short term memory, and attention) assessed by the Creyos cognitive battery, and changes in depressive symptoms measured by the Patient Health Questionnaire-9 (PHQ-9). Assessments are performed at baseline, post treatment, 1-month follow-up, and 3-month follow-up. Total study duration per participant is up to 139 days.