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New treatment option for Parkinson Disease (PD)
Official title Modulate Tremor Severity With Low-intensity Focused Ultrasound Stimulation Targeting the Deep Nucleus of Patients With Refractory Hand Tremor.
ClinicalTrials.gov ID: NCT07172295
What this study is testing
- What it's testing
- The study plans to recruit 12 patients with Parkinsonian tremor, essential tremor, or dystonic tremor. After receiving NaviFUS-ctbTUS stimulation, the improvement in their tremor will be recorded.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Age between 18 and 80 years.
- people must belong to one of the following three categories:
- Patients with Parkinson's disease tremor who have an inadequate response to medication.
- Patients with essential tremor who have an inadequate response to medication.
- Patients with dystonic tremor who have an inadequate response to medication.
You likely can't join if
- Presence of intracranial implants deemed unsuitable for MRI, such as metal clips, ventriculoperitoneal (VP) shunts, cochlear implants, deep brain...
- Any abnormalities along the focused ultrasound beam path through the skull, including scars on the skull, scalp conditions (e.g., eczema), open...
- Pregnant or breastfeeding women.
- Use of investigational drugs from other clinical trials.
- Patients with major depressive disorder (Beck Depression Inventory-II score \> 30 within the past year) or with suicidal ideation.
- Any condition that, in the opinion of the investigator, may interfere with treatment how well it works or increase risk to the subject.
See the full eligibility criteria
- Age between 18 and 80 years.
- people must belong to one of the following three categories:
- Patients with Parkinson's disease tremor who have an inadequate response to medication.
- Patients with essential tremor who have an inadequate response to medication.
- Patients with dystonic tremor who have an inadequate response to medication.
- people are willing to shave hair over the treatment area for focused ultrasound.
- Stable medication regimen (types and dosages) for at least 4 weeks prior to study enrollment.
- Normal liver and renal function (Creatinine \< 1.3 mg/dL, GPT \< 41 U/L).
- Female participants of childbearing potential, or male participants with female partners of childbearing potential, must agree to use appropriate contraception from the first study treatment until at least 6 months...
- Presence of intracranial implants deemed unsuitable for MRI, such as metal clips, ventriculoperitoneal (VP) shunts, cochlear implants, deep brain stimulation (DBS) devices, pacemakers, or implantable cardioverter-...
- Any abnormalities along the focused ultrasound beam path through the skull, including scars on the skull, scalp conditions (e.g., eczema), open wounds, calp atrophy, or significant calcification confirmed by imaging...
- Pregnant or breastfeeding women.
- Use of investigational drugs from other clinical trials.
- Patients with major depressive disorder (Beck Depression Inventory-II score \> 30 within the past year) or with suicidal ideation.
- Any condition that, in the opinion of the investigator, may interfere with treatment how well it works or increase risk to the subject.
- Presence of any brain tumors, vascular malformations, or significant traumatic brain injury.
- Presence of significant psychiatric symptoms (Clinical Dementia Rating [CDR]
- Use of anticoagulant medications.
- Use of medications known to exacerbate tremor.
- Tremor due to metabolic or psychogenic causes.
- Coagulopathy or abnormal coagulation profiles, including any of the following:
- Platelet count ≤ 100,000/µL
- INR ≥ 1.5
- PT ≥ 1.5 × upper limit of normal (ULN)
- aPTT ≥ 1.5 × ULN
- Fibrinogen ≤ 150 mg/dL
- Inability to provide informed consent or comply with study procedures, posing potential safety concerns.
- Insufficient skull density as determined by pre-treatment evaluation, resulting in ultrasound transmission efficiency less than 20%.
The study team makes the final eligibility decision.
Where it's taking place
- Hsinchu, Hsinchu City, Taiwan
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 - 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, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hsinchu, Hsinchu City, Taiwan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.