PARKINSON DISEASE study: TMS
Official title Effects of Accelerated rTMS On Motor and Cognitive Function in Parkinson's Disease
ClinicalTrials.gov ID: NCT07554833
What this study is testing
- What it's testing
- This study aims to find out if a specific type of brain stimulation can improve movement and thinking skills in people with Parkinson's disease.
- Who it's for
- The study is looking for adults aged 50 to 90 who have mild to moderate Parkinson's disease.
- What's involved
- Participants will receive six sessions of a painless brain stimulation treatment using a device placed on the head. They will also complete tests to check their movement, walking, memory, and mood before and after the treatment.
- Time commitment
- The study lasts up to 139 days and includes visits for screening, treatment, and follow-up checks at 1 and 3 months.
You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 to 90
You may be able to join if
- 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...
- 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...
You likely can't join if
- 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...
- Metallic, ferromagnetic, or other magnetic-sensitive implants/objects in or near the head - rTMS devices are contraindicated for use in patients who...
- 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...
- 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.
See the full eligibility criteria
Who can join
- 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...
- 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.
- people 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...
- people 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.
What rules you out
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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)
- 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...
- 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...
- 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.
- people 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it is enrolling
- San Francisco, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years to 90 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at San Francisco, California, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.