Optimizing Parameters of Low-Intensity Focused Ultrasound for Pallidal Modulation in Huntington's Disease

Sponsor
First Affiliated Hospital of Fujian Medical University
Study ID
NCT07513844
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Low-Intensity Focused Ultrasound Stimulation（LIFU） — DEVICE
    This is not a traditional three-arm parallel trial but a Stage I/II dose-finding study using an adaptive design. Participants are dynamically assigned to three pulse repetition frequency levels (10 Hz, 50 Hz, 100 Hz) based on predefined rules, rather than fixed randomization. The study adopts a two-stage utility-based Bayesian optimal interval (U-BOIN) design: Stage I: Dose decisions are based solely on dose-limiting toxicity (DLT) incidence. Participants are enrolled in cohorts of three. Based on observed DLTs, the next cohort's dose is determined (escalate/stay/de-escalate). Stage II: When any dose group reaches 6 participants or the highest dose is explored, safety and efficacy data are integrated to calculate a utility value. Subsequent cohorts are assigned to the dose group with the highest utility value. The study stops when any dose group reaches 12 participants or total enrollment reaches 24. Not all three dose levels may be utilized. Allocation is not fixed a priori.

Study Details

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.

Key Dates

Start date
Apr 20, 2026
Status verified
Mar 2026
Primary completion
Oct 31, 2026
Completion
Mar 31, 2027

Study Design

Enrollment
24 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: 10 Hz LIFU Group
    Low-Intensity Focused Ultrasound (LIFU), PRF 10 Hz
  • Experimental: 50 Hz LIFU Group
    Low-Intensity Focused Ultrasound (LIFU), PRF 50 Hz
  • Experimental: 100 Hz LIFU Group
    Low-Intensity Focused Ultrasound (LIFU), PRF 100 Hz

Primary Outcome Measure

Safety: Incidence of Dose-Limiting Toxicity (DLT) [ Time Frame: At any point during or immediately following intervention on day of LIFUS application ]

Central Contacts

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