Recruiting

rTMS

Sponsor:

San Francisco Neurology and Sleep Center

Code:

NCT07554833

Conditions

PARKINSON DISEASE (Disorder)

Parkinson s Disease

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

Interventions

TMS

Study Details

Brief 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.

Conditions

PARKINSON DISEASE (Disorder)

Parkinson s Disease

Study ID

NCT07554833

Start date

Jun 3, 2026

Status verified date

Jun, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Nov 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

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 anticipated changes during the study period.
  • Ability to provide written informed consent.
  • Subject must sign an ICF indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study.
  • Sufficient visual and auditory acuity to complete motor and cognitive assessments.
  • Availability and willingness to complete all scheduled study visits.
  • Presence of a reliable study partner or caregiver who can provide information about the participant's motor, cognitive, and functional status.
  • Ability to determine the motor threshold of the participant. The participant's motor threshold could be established as the minimum stimulus required to induce contraction of the contralateral hand muscles.
  • Subjects willing and able to abstain from partaking in any treatments other than the study procedure for the improvement in motor or cognitive function, including non-invasive brain stimulation treatments other than the study procedure during study participation.
  • Subjects willing and able to maintain their regular (pre-procedure) medication regimen, diet, and exercise routine without affecting significant change in either direction during study participation.
  • Willingness to comply with study instructions and to return to the clinic for the required visits.
  • Women of child-bearing potential are required to use birth control measures during the whole duration of the study.

Exclusion Criteria:

  • Electronic implants in or near the head - rTMS devices are contraindicated for use in patients who have active or inactive implants in or near the head including device leads, deep brain stimulators, cochlear implants, ocular implants, and vagus nerve stimulators, implanted devices such as cardiac pacemakers, defibrillators, and neurostimulators.
  • Metallic, ferromagnetic, or other magnetic-sensitive implants/objects in or near the head - rTMS devices are contraindicated for use in patients who have conductive, ferromagnetic, or other magnetic-sensitive metals implanted in their head (with some exceptions in the mouth - see Operator's Manual) or within 12 inches (30 cm) of the therapy coil. Examples include implanted electrodes/stimulators, aneurysm clips or coils, stents, bullet fragments, jewelry, hair barrettes, and tattoos with metallic ink.
  • Drug pumps within 12 inches (30 cm) of the therapy coil.
  • Inability to determine the motor threshold of the participant (i.e., the minimum stimulus required to induce contraction of the contralateral hand muscles cannot be established).
  • History of seizure disorder or epilepsy, except for a single remote seizure more than 5 years ago, which may be permitted at investigator discretion.
  • Elevated risk of seizure due to traumatic brain injury with loss of consciousness >30 minutes within the past 12 months.
  • Current use of medications known to significantly lower seizure threshold (e.g., clozapine, bupropion at doses >450 mg/day, theophylline, high-dose tricyclic antidepressants) or recent dose reduction of anticonvulsant medications or benzodiazepines within 4 weeks of screening.
  • Atypical parkinsonism or Parkinson-plus syndromes (e.g., progressive supranuclear palsy, multiple system atrophy, corticobasal degeneration).
  • Hoehn and Yahr stage 4 or 5 (severe disease with significant disability).
  • Severe dementia, defined as MoCA score below 10, or inability to follow simple verbal commands or complete basic motor and cognitive assessments.
  • Rapidly progressive cognitive decline or suspected prion disease, autoimmune encephalitis.
  • Brain tumor, intracranial hemorrhage within the past 12 months, arteriovenous malformation, or increased intracranial pressure.
  • Acute stroke within the past 3 months.
  • Prior deep brain stimulation (DBS) surgery or other neurosurgical procedures for Parkinson's disease.
  • Has a current diagnosis of psychotic disorder, bipolar disorder, or other psychiatric condition that, in the investigator's opinion, would interfere with the subject's ability to participate in the trial.
  • Has a current or recent history of serious suicidal ideation within the past 6 months, corresponding to a positive response on item 4 (active suicidal ideation with some intent to act, without specific plan) or item 5 (active suicidal ideation with specific plan and intent) on the C-SSRS, or a history of suicidal behavior within the past year, as validated by the C-SSRS at screening.
  • History of substance or alcohol use disorder of moderate to severe severity according to DSM-5 criteria within 6 months before screening, or positive test result(s) for drugs of abuse (including opiates, cocaine, cannabinoids, methamphetamines, amphetamines) at screening.
  • Has history of or current clinically significant and/or unstable medical condition that could interfere with study participation or pose safety concerns, including but not limited to: Moderate or severe hepatic impairment (Child-Pugh Score ≥7); Severe renal impairment (estimated creatinine clearance below 30 mL/min or serum creatinine >2 mg/dL); Unstable cardiac, vascular, or pulmonary disease Note: Subjects with chronic but stable, well-controlled conditions may be allowed in the study upon agreement with the investigator.
  • Has uncontrolled hypertension (systolic blood pressure >160 mm Hg or diastolic blood pressure >100 mm Hg, despite diet, exercise, or a stable dose of antihypertensive therapy) at screening.
  • Has clinically significant ECG abnormalities at screening, defined as: QTc interval (Fridericia's formula): ≥450 msec (males); ≥470 msec (females); Evidence of 2nd or 3rd degree atrioventricular block, or 1st degree atrioventricular block with PR interval >210 msec; Left bundle branch block; Features of new ischemia; Other clinically important arrhythmia
  • Has a known malignancy or history of malignancy within 5 years before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy that, in the opinion of the investigator, is considered cured with minimal risk of recurrence).
  • Had clinically significant acute illness within 7 days prior to study rTMS treatment.
  • Had major surgery (e.g., requiring general anesthesia) within 2 weeks before screening, or will not have fully recovered from surgery, or has surgery planned during the time the subject is expected to participate in the study. Note: Subjects with planned surgical procedures to be conducted under local anesthesia may participate.
  • Is pregnant or breastfeeding while enrolled in this study or within 1 month after the last session of study rTMS treatment.
  • Has received an investigational drug or used an invasive investigational medical device within 3 months before screening, or is currently enrolled in an investigational study.
  • Prior treatment with rTMS within 6 months of screening.
  • Subjects willing to partake in any treatments other than the study procedure for the improvement in cognitive function, including non-invasive brain stimulation treatments other than the study procedure, during study participation.
  • Has psychological and/or emotional problems which would render the informed consent invalid, or limit the ability of the subject to comply with the study requirements.
  • Has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the subject (e.g., compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments.
  • Is an employee of the investigator or study site, with direct involvement in the proposed study or other studies under the direction of that investigator or study site, as well as family members of the employees or the investigator.

Study Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

TMS

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.

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 and Locations

Central contacts

Joy Shihui Meng, MD

415-666-2536joymengmd@sf-neurology.com

Junyi Sun, MD, PhD

628-249-5656office@sf-neurology.com

Locations

San Francisco Neurology and Sleep Center

Recruiting

San Francisco, California, United States, 94108

Contacts

Joy Meng, MD

415-666-2536office@sf-neurology.com

Junyi Sun, MD, PhD

415-666-2536office@sf-neurology.com

Principal Investigator:

Joy Meng, MD

More Information

Sponsor

San Francisco Neurology and Sleep Center

Last update posted

Jun 16, 2026

Last verified

Jun, 2026

Keywords

  • rTMS
  • ExoMind
  • Parkinson's Disease
  • PD
  • Cognitive Function

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by San Francisco Neurology and Sleep Center on 2026-06-16.