Trial · NCT07168850
Focused Ultrasound Unilateral Pallidotomy for Medication-Refractory Limb Dystonia
NCT07168850, Not applicable, Recruiting, Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Focused Ultrasound Unilateral Pallidotomy for Medication-Refractory Limb Dystonia. Trials, record NCT07168850. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07168850
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Focused Ultrasound Unilateral Pallidotomy for Medication-Refractory Limb Dystonia
- NCT number
- NCT07168850
- Status
- Recruiting
- Phases
- Not applicable
- Enrollment
- 34 participants, estimated
- Lead sponsor
- Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
- Conditions
- Limb Dystonia, Idiopathic Dystonia, Medication-refractory Dystonia, Dystonia, Focal
- Interventions
- Exablate MR-guided Focused Ultrasound Pallidotomy, Sham Sham Exablate MRgFUS Pallidotomy
- First posted
- 2025-09-11
- Last updated
- 2026-11-05
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Chenge in the Burke-Fahn-Marsden Dystonia Rating Scale (BFMDRS) | Baseline to Week 12 | The BFMDRS has a maximum score of 120 for the movement subscale and 30 for the disability subscale. Higher scores indicating more severe dystonia. |
| Secondary | Incidence of treatment-related adverse events | Baseline to Week 24 | Assessment of any treatment-related adverse events throughout the whole study period |
| Secondary | Changes in the Quick Disabilities of Arm, Shoulder & Hand (Quick-DASH) score | Baseline, Week 12 and Week 24 | The QuickDASH is a shortened, 11-item version of the DASH Outcome Measure, designed to assess physical function and symptom severity related to the arm, shoulder, and hand. Maximum score 100; the greater the score the grear the disability. |
| Secondary | Changes in the Clinical Global Impression of Change (CGIC) score | Baseline, week 12 and week 24 | The CGIC is a 7-point scale used to assess the degree of change in a patient's condition since the start of treatment or another defined baseline. Lower scores indicates improvement and higher scores indicating worsening of the patient's condition. |
| Secondary | Patient Global Impression of Change (PGIC) | Baseline, Week 12 and week 24 | The maximum score of the PGIC is 7: the higher the score the higher the improvement reported by a patient. |
| Secondary | Change in the 36-Item Short Form Survey (SF-36) score | Baseline, week 12 and week 24 | The SF-36 questionnaire has a maximum score of 100 for each of its eight scaled scores (physical functioning, role limitations due to physical health, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, and mental health). The higher the scores the more favorable is health state within that specific dimension. |
| Secondary | Changes in the Short-Interval Cortical Inhibition (SICI) | Baseline and Week 24 | This is a neurophysiological measure of inhibitory processes within the motor cortex, assessed using Transcranial Magnetic Stimulation, which is measured as the relative amplitude reduction of motor evoked potentials from the test stimulus when it is preceded by the conditioning stimulus. The greater the change in SICI, the greater the pallidotomy-induced changes in motor cortex intracortical inhibitory circuits |
| Secondary | Changes in intracortical facilitation (ICF) | Baseline and Week 24 | This is a neurophysiological measures of cortical excitability, assessed using paired-pulse Transcranial Magnetic Stimulation, which describes an increase in the magnitude of a motor evoked potential in a target muscle when a suprathreshold test pulse is preceded by a subthreshold conditioning pulse at specific interstimulus intervals. The greater the change in ICF, the greater the pallidotomy-induced changes in intracortical excitatory circuits |
| Secondary | Changes in Paired Associative Stimulation (PAS) | Baseline and week 24 | This is a neurophysiological measure of cortical plasticity assessed using transcranial magnetic stimulation. The greater the change in PAS, the greater the pallidotomy-induced changes in motor cortex synaptic plasticity |
| Secondary | Changes in brain activity (using functional connectivity) using resting-state functional magnetic resonance imaging (rs-fMRI) | Baseline and Week 24 | The investigators will conduct a region-of-interest analysis to calculate changes of fMRI functional connectivity between baseline and post-pallidotomy. |
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.
Papers11
The papers the trial lists on ClinicalTrials.gov.
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.
Tests2
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 |
|---|---|---|
| Digit Span Test | Secondary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone 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/NCT07168850
GET https://conductscience.org/api/trials/v1/NCT07168850/registered