| NCT ID | NCT07284719 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Aarhus University Hospital |
| Condition | Parkinson s Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2025-12-01 |
| Primary Completion | 2028-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2025-12-01 with a primary completion date of 2028-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study investigates magnetic resonance-guided focused ultrasound thalamotomy (MRgFUSth) for people with Parkinson's disease (PD) and tremor not responding to conventional standard doses of dopamine replacement therapy. The aim is to identify clinical and imaging biomarkers predictive of sustained tremor control up to 24 months after MRgFUSth treatment. Participants will undergo a suprathreshold levodopa test and ¹⁸F-DOPA PET imaging to evaluate dopaminergic and serotonergic involvement in tremor. All participants will receive MRgFUSth and be followed for 24 months with standardized clinical, cognitive, and quality-of-life assessments. The study seeks to improve understanding the possible mechanisms of tremor relapse and inform patient selection for MRgFUSth in PD.
Eligibility Criteria
Inclusion Criteria: * Established diagnosis of idiopathic Parkinson's disease * Tremor not manageable with optimal medication * Clinical Indication for MRgFUSth * Able to understand study requirements and provide consent * HOEHN and YAHR \<3 Exclusion Criteria: * Dementia or severe cognitive impairment * The presence of another significant neurological/psychiatric disorder or significant disease * Severe psychopathology, not medically managed * Poor balance and gait function based on neurological examination * Epilepsy * Active drug abuse * History of stroke or structural lesions on MRI that could interfere with image analysis. * Contraindications for MRI * Cardiac pacemaker * Pregnancy or breast-feeding * Claustrophobia * Patients unable to lie on the back for 2-4 hours in the MR-scanner-setting * Patients who do not want information about findings of unknown disease during the trial * SDR (Skull density rate) lower than 0.35
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07284719 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, up to 80 Years, studying Parkinson s Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07284719 currently recruiting?
Yes, NCT07284719 is actively recruiting participants. Contact the research team at andglu@rm.dk for enrollment information.
Where is the NCT07284719 trial being conducted?
This trial is being conducted at Aarhus, Denmark.
Who is sponsoring the NCT07284719 clinical trial?
NCT07284719 is sponsored by Aarhus University Hospital. The trial plans to enroll 20 participants.
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