Optimizing Parameters of Low-Intensity Focused Ultrasound for Pallidal Modulation in Huntington's… (NCT07513844) | Clinical Trial Compass
RecruitingNot Applicable
Optimizing Parameters of Low-Intensity Focused Ultrasound for Pallidal Modulation in Huntington's Disease
China24 participantsStarted 2026-04-20
Plain-language summary
The purpose of this research study is to determine the optimal pulse repetition frequency of low-intensity focused ultrasound that is safe and effective in improving motor symptoms in patients with Huntington's disease.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Aged 18 to 75 years (inclusive)
✓. Genetically confirmed Huntington's disease with HTT CAG repeat length of 40 or greater
✓. 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
✓. Huntington's Disease Integrated Staging System stage 2 or 3
✓. Willing to participate and provide informed consent
✓. Have a reliable caregiver available
✓. No severe cognitive impairment that would preclude reliable reporting of adverse events or efficacy during treatment
Exclusion criteria
✕. History of self-injury, aggressive behavior, or unstable psychiatric disorders
✕. History of head injury or neurosurgical procedure
✕. Presence of intracranial implants, metallic foreign bodies, cochlear implants, or cardiac pacemakers
✕. Severe systemic disease, pregnancy, or breastfeeding
✕. Contraindications to magnetic resonance imaging, ultrasound, or anesthesia
✕. 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
What they're measuring
1
Safety: Incidence of Dose-Limiting Toxicity (DLT)
Timeframe: At any point during or immediately following intervention on day of LIFUS application
2
Efficacy: Change in Unified Huntington's Disease Rating Scale Total Motor Score (UHDRS-TMS)
Timeframe: Baseline and within 2 days after completing the 5-day LIFU treatment
3
Comprehensive Benefit-Risk: Utility
Timeframe: Within 2 days after completing the 5-day LIFU treatment
Trial details
NCT IDNCT07513844
SponsorFirst Affiliated Hospital of Fujian Medical University