Effects of Accelerated rTMS On Motor and Cognitive Function in Parkinson's Disease

Part of paid clinical trials in San Francisco, California.

Sponsor
San Francisco Neurology and Sleep Center
Study ID
NCT07554833
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

  • PARKINSON DISEASE (Disorder)
  • Parkinson s Disease

Eligibility Criteria

Sex
ALL
Age
50 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • TMS — DEVICE
    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.

Study Details

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.

Key Dates

Start date
May 1, 2026
Status verified
Apr 2026
Primary completion
Nov 1, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Active Comparator: rTMS Treatment
    Participants with mild to moderate idiopathic Parkinson's disease (Hoehn and Yahr stage 1-3) receive 6 sessions of high-frequency repetitive transcranial magnetic stimulation (rTMS) using the EXOMIND™ device (BTL-699-2), administered twice weekly over approximately 3 weeks. Each session delivers bilateral stimulation to the primary motor cortex (M1) at 10-20 Hz and 90-110% of resting motor threshold, with 3,000-6,000 total pulses per session. Participants maintain their stable pre-study anti-parkinsonian medication regimen throughout the study. Motor function (MDS-UPDRS-III, Freezing of Gait Questionnaire, Timed Up and Go Test, gait speed), cognitive function (Montreal Cognitive Assessment, Creyos cognitive battery), depressive symptoms (PHQ-9), and quality of life (PDQ-39) are assessed at baseline, last treatment session, 1-month follow-up, and 3-month follow-up.

Primary Outcome Measure

Change from baseline in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III (MDS-UPDRS-III) score at 1-month follow-up [ Time Frame: From baseline to the 1-month follow up ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
San Francisco Neurology and Sleep CenterSan FranciscoCalifornia94108
Joy Meng, MD
[email protected]
415-666-2536
Junyi Sun, MD, PhD
[email protected]
415-666-2536
Joy Meng, MD (PRINCIPAL_INVESTIGATOR)
Junyi Sun, MD, PhD (SUB_INVESTIGATOR)

Find similar trials in San Francisco, CA

By research site
San Francisco Neurology and Sleep Center· San Francisco, CA

Related Studies