Clinical Effects of Accelerated rTMS Targeting Motor Cortex on Motor and Cognitive Function in Parkinson's Disease: A Prospective Pilot Study
San Francisco Neurology and Sleep Center
Summary
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.
Description
Background and Rationale: Parkinson's disease (PD) affects approximately 1-2% of adults over age 60 and is characterized by progressive motor symptoms including bradykinesia, rigidity, resting tremor, and postural instability. Cognitive impairment is also common, with approximately 50% of people with PD experiencing mild cognitive impairment and cumulative dementia prevalence reaching up to 80% over the disease course. Current pharmacological treatments provide symptomatic motor benefit but are limited by declining efficacy over time, motor fluctuations, dyskinesias, and other side effects. N…
Eligibility
- Age range
- 50–90 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Subject must be 50 to 90 years of age, inclusive, on the day of signing informed consent. * Diagnosis of idiopathic Parkinson's disease according to the Movement Disorder Society Clinical Diagnostic Criteria or UK Parkinson's Disease Society Brain Bank criteria. * Hoehn and Yahr stage 1-3 (mild to moderate disease severity). * MDS-UPDRS-III (Motor Examination) score ≥10 at screening. * Stable doses of anti-parkinsonian medications (including levodopa, dopamine agonists, MAO-B inhibitors, COMT inhibitors, amantadine) for at least 4 weeks prior to screening, with no antici…
Interventions
- DeviceTMS
The open-label treatment phase will consist of 6 sessions of rTMS using the EXOMIND™ device (BTL-699-2), administered twice a week over approximately 3 weeks. Each session will deliver high-frequency stimulation (10-20 Hz) at 90-110% of resting motor threshold (RMT), with 3,000-6,000 total pulses per session. The target site will be the primary motor cortex (M1), with bilateral stimulation. The motor cortex will be localized using the standard motor threshold determination procedure, identifying the scalp position that produces consistent contraction of the contralateral hand muscles. The procedure will be conducted at San Francisco Neurology and Sleep Center with medical staff support.
Location
- San Francisco Neurology and Sleep CenterSan Francisco, California