Trial · NCT07513844
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Safety: Incidence of Dose-Limiting Toxicity (DLT) | At any point during or immediately following intervention on day of LIFUS application | DLT refers to the occurrence of any of the following six events during LIFU treatment: 1. Second-degree scalp burn; 2. Clinical seizure; 3. Worsening of chorea or new movement disorder; 4. Significant deterioration of the patient's mood or mental status (e.g., anxiety, depression, hallucinations, excessive sleepiness); 5. Severe autonomic dysfunction, such as marked blood pressure fluctuations, abnormal heart rate, or respiratory distress; 6. Imaging-related safety events: new or significantly enlarged brain edema, new microbleeds, new infarcts, or structural abnormalities in the treatment area on post-treatment cranial MRI compared with baseline, deemed clinically significant by both radiologists and clinicians. |
| Primary | Efficacy: Change in Unified Huntington's Disease Rating Scale Total Motor Score (UHDRS-TMS) | Baseline and within 2 days after completing the 5-day LIFU treatment | The Unified Huntington's Disease Rating Scale Total Motor Score (UHDRS-TMS) evaluates motor impairment in Huntington's disease. Score range: 0-124 Higher scores indicate more severe motor impairment Response is defined as a reduction of ≥4 points from baseline. |
| Primary | Comprehensive Benefit-Risk: Utility | Within 2 days after completing the 5-day LIFU treatment | Utility is a composite measure integrating dose-limiting toxicity (DLT) and efficacy response to quantify the overall benefit-risk balance for each dose group. During the trial, the Utility value for each dose group is dynamically calculated using the U-BOIN design platform. In Stage II, the Utility value determines dose allocation for subsequent cohorts. At study completion, the dose group with the highest Utility value is identified as the optimal biological dose. |
| Other | Patient Global Impression of Change (PGI-C) | Within 2 days after completing the 5-day LIFU treatment | The Patient Global Impression of Change (PGI-C) is a patient-reported scale assessing perceived change in overall condition after treatment. Score range: 1-7 Lower scores indicate greater improvement |
| Other | Clinical Global Impression of Change (CGI-C) | Within 2 days after completing the 5-day LIFU treatment | The Clinical Global Impression of Change (CGI-C) is a clinician-rated scale assessing overall change in the patient's clinical status. Score range: 1-7 Lower scores indicate greater improvement |
| Other | Change in Unified Huntington's Disease Rating Scale Chorea Score | Baseline and within 2 days after completing the 5-day LIFU treatment | The UHDRS Chorea Score evaluates severity of choreiform movements. Score range: 0-28 Higher scores indicate more severe chorea |
| Other | Change in Symbol Digit Modalities Test (SDMT) | Baseline and within 2 days after completing the 5-day LIFU treatment | The Symbol Digit Modalities Test (SDMT) is a cognitive assessment of processing speed and attention. Score range: 0-110 (number of correct matches within 90 seconds) Higher scores indicate better cognitive function |
| Other | Change in Controlled Oral Word Association Test (COWAT) | Baseline and within 2 days after completing the 5-day LIFU treatment | The Controlled Oral Word Association Test (COWAT) assesses verbal fluency and executive function. Score range: 0-unlimited (total number of words generated across three trials, each 60 seconds) Higher scores indicate better verbal fluency and executive function |
| Other | Change in Stroop Interference Test Score | Baseline and within 2 days after completing the 5-day LIFU treatment | The Stroop Interference Test assesses cognitive inhibition and executive function. Score range: 0-unlimited (number of correct responses on the interference task within a time limit) Higher scores indicate better cognitive function |
| Other | Change in Functional Independence Scale | Baseline and within 2 days after completing the 5-day LIFU treatment | The Functional Independence Scale assesses a patient's level of independence in daily activities. Score range: 0-100 Higher scores indicate greater independence |
| Other | Change in Total Functional Capacity (TFC) | Baseline and within 2 days after completing the 5-day LIFU treatment | The Total Functional Capacity (TFC) scale is a component of the Unified Huntington's Disease Rating Scale (UHDRS) that assesses functional capacity. Score range: 0-13 Higher scores indicate better functional capacity |
| Other | Change in Functional Assessment Score | Baseline and within 2 days after completing the 5-day LIFU treatment | The Functional Assessment Score is a component of the Unified Huntington's Disease Rating Scale (UHDRS) that assesses the patient's ability to perform specific tasks. Score range: 0-25 Higher scores indicate better functional ability |
| Other | Change in Serum Neuron-Specific Enolase (NSE) | Baseline and within 2 days after completing the 5-day LIFU treatment | Serum Neuron-Specific Enolase (NSE) is a biomarker of neuronal injury. Unit of measure: ng/mL Higher levels indicate more neuronal damage |
| Other | Change in Multimodal Magnetic Resonance Imaging (MRI) Parameters | Baseline and within 2 days after completing the 5-day LIFU treatment | Change from baseline in structural and functional brain connectivity metrics as assessed by multimodal MRIto evaluate the neuromodulatory effects of LIFU. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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