Low-intensity focused ultrasound targeting the globus pallidus to improve movement in Huntington's disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase I/II adaptive dose-finding study delivers LIFU to the external globus pallidus using MRI-derived individualized head models and real-time neuronavigation. Three pulse repetition frequencies (10 Hz, 50 Hz, 100 Hz) are evaluated using a Bayesian optimal interval design with sequential cohorts of three and utility-driven dose escalation that integrates safety and early efficacy data. Each participant receives ten LIFU sessions over five consecutive days (two sessions per day) while motor function, cognitive measures, and adverse events are monitored. The primary goal is to identify the pulse frequency that best balances safety with improvement in motor symptoms.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Aged 18 to 75 years (inclusive)
2. Genetically confirmed Huntington's disease with HTT CAG repeat length of 40 or greater
3. Unified Huntington's Disease Rating Scale Total Maximal Chorea score of 8 or higher on a scale of 0 to 28, with higher scores indicating more severe chorea
4. Huntington's Disease Integrated Staging System stage 2 or 3
5. Willing to participate and provide informed consent
6. Have a reliable caregiver available
7. No severe cognitive impairment that would preclude reliable reporting of adverse events or efficacy during treatment

Exclusion Criteria:

1. History of self-injury, aggressive behavior, or unstable psychiatric disorders
2. History of head injury or neurosurgical procedure
3. Presence of intracranial implants, metallic foreign bodies, cochlear implants, or cardiac pacemakers
4. Severe systemic disease, pregnancy, or breastfeeding
5. Contraindications to magnetic resonance imaging, ultrasound, or anesthesia
6. Prior treatment with electroconvulsive therapy, transcranial magnetic stimulation, transcranial direct current stimulation, transcranial alternating current stimulation, or other neuromodulation therapies within the past 3 years
7. Severe brain atrophy with unclear external globus pallidus structure on MRI
8. Concurrent participation in another interventional clinical trial
9. Any other condition that, in the opinion of the investigator, would preclude participation

Where it's running

• Department of Rehabilitation Medicine, The First Affiliated Hospital of Fujian Medical University
  Fuzhou, Fujian, China Recruiting

Study contacts

• Study coordinator: Xin-Yuan Chen
• Email: fychenxinyuan@fjmu.edu.cn
• Phone: +86 15005065282

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.