Trial · NCT07513844
Optimizing Parameters of Low-Intensity Focused Ultrasound for Pallidal Modulation in Huntington's Disease
NCT07513844, Not applicable, Recruiting, First Affiliated Hospital of Fujian Medical University
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Optimizing Parameters of Low-Intensity Focused Ultrasound for Pallidal Modulation in Huntington's Disease. Trials, record NCT07513844. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07513844
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Optimizing Parameters of Low-Intensity Focused Ultrasound for Pallidal Modulation in Huntington's Disease
- NCT number
- NCT07513844
- Status
- Recruiting
- Phases
- Not applicable
- Enrollment
- 24 participants, estimated
- Lead sponsor
- First Affiliated Hospital of Fujian Medical University
- Conditions
- Huntington Disease
- Interventions
- Low-Intensity Focused Ultrasound Stimulation（LIFU）
- First posted
- 2026-04-07
- Last updated
- 2026-04-29
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests3
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Stroop Color-Word Test | Other outcome | ConductCognition |
| Symbol Coding | Other outcome | ConductCognition |
| Verbal Fluency | Other outcome | ConductCognition |
Data dates
The day each source was copied for this release.
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07513844
GET https://conductscience.org/api/trials/v1/NCT07513844/registered