Magnetic-Resonance Guided Focused Ultrasound Pallidothalamic Tractotomy for Parkinson's Disease
NCT07925086, Not applicable, Not yet recruiting, Research Center of Neurology, Russia
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Magnetic-Resonance Guided Focused Ultrasound Pallidothalamic Tractotomy for Parkinson's Disease | ClinicalTrials.gov |
| NCT number | NCT07925086 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 168 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Research Center of Neurology, Russia | ClinicalTrials.gov |
| Conditions | Parkinson Disease (PD) | ClinicalTrials.gov |
| Interventions | MR-guided Focused Ultrasound Pallidothalamic Tractotomy, MR-guided Focused Ultrasound VIM Thalamotomy, Combined MR-guided Focused Ultrasound PTT and VIM Treatment, best medical therapy | ClinicalTrials.gov |
| First posted | 2026-11-09 | ClinicalTrials.gov |
| Last updated | 2026-11-12 | ClinicalTrials.gov |
Registered outcomes 18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Change From Baseline in Contralateral MDS-UPDRS Part III ULE score in the OFF-medication at 6 Months (PTT vs Delayed Treatment) | Baseline and 6 months after initial randomization | Change in the summed Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III items for the ULE contralateral to the treatment side: limb rigidity, bradykinesia and tremor. Score range 0-44; higher scores indicate worse motor impairment. Evaluated in the practically defined medication-OFF state by an independent blinded neurologist. Primary contrast: PTT vs delayed medical treatment. | ClinicalTrials.gov |
| Primary | Change From Baseline in Contralateral MDS-UPDRS Part III Tremor Sub-score in the OFF-medication at 6, 12 Months (PTT+VIM vs PTT) | Baseline, 6 months, and 12 months after initial MRgFUS treatment | Change in the sum of the contralateral tremor items from MDS-UPDRS Part III, score range 0-16; higher scores indicate worse tremor. Evaluated in the practically defined medication-OFF state by an independent blinded neurologist. Primary contrast: combined PTT+VIM versus PTT alone. Preoperative baseline is the reference assessment. | ClinicalTrials.gov |
| Primary | Change From Baseline in Contralateral MDS-UPDRS Part III Bradykinesia and Rigidity Sub-score in the OFF-medication at 6, 12 Months (PTT+VIM vs VIM) | Baseline, 6 months, and 12 months after initial MRgFUS treatment | Change in contralateral limb rigidity and bradykinesia items on MDS-UPDRS Part III, score range 0-28; higher scores indicate worse motor impairment. Evaluated in the practically defined medication-OFF state by an independent blinded neurologist. Primary contrast: combined PTT+VIM versus VIM alone. | ClinicalTrials.gov |
| Secondary | Change From Baseline in Contralateral MDS-UPDRS III ULE score in the OFF-medication at 6, 12 Months (PTT vs VIM) | Baseline, 6, and 12 months after initial MRgFUS treatment | Change in the summed MDS-UPDRS Part III items for the ULE contralateral to the treatment side: limb rigidity, bradykinesia and tremor. Score range 0-40; higher scores indicate worse motor impairment. Evaluated in the practically defined medication-OFF state by an independent blinded neurologist. Key secondary prespecified PTT-versus-VIM contrast in medication-OFF state. | ClinicalTrials.gov |
| Secondary | Change From Baseline in Contralateral MDS-UPDRS Part III ULE score in the OFF-medication at 6 Months (VIM or PTT+VIM vs Delayed Treatment) | Baseline and 6 months after initial randomization | Change in the summed MDS-UPDRS Part III items for the ULE contralateral to the treatment side: limb rigidity, bradykinesia and tremor. Score range 0-40; higher scores indicate worse motor impairment. Evaluated in the practically defined medication-OFF state by an independent blinded neurologist. Two key secondary comparisons: VIM vs delayed treatment and PTT+VIM vs delayed treatment, medication-OFF state. | ClinicalTrials.gov |
| Secondary | Change From Baseline in Parkinson's Disease Questionnaire-39 Summary Index at 6 Months (PTT vs Delayed Treatment) | Baseline and 6 months after initial randomization | Parkinson's Disease Questionnaire-39 (PDQ-39) Summary Index, scaled 0-100; higher scores indicate worse health-related quality of life. Key secondary PTT-versus-delayed-treatment contrast. | ClinicalTrials.gov |
| Secondary | Change From Baseline in PDQ-39 Summary Index at 6, 12 Months (PTT vs PTT+VIM) | Baseline, 6, and 12 months after initial MRgFUS treatment | PDQ-39 Summary Index, 0-100; higher scores indicate worse health-related quality of life. Key secondary comparison of PTT with PTT+VIM. | ClinicalTrials.gov |
| Secondary | Change From Baseline in Total MDS-UPDRS Part III Score in Medication-OFF State | Baseline, 6, and 12 months after MRgFUS treatment | Total MDS-UPDRS Part III motor examination score, range 0-132, with higher values indicating worse motor impairment. Analyzed over follow-up visits; active groups' visits are measured from intervention. | ClinicalTrials.gov |
| Secondary | Change From Baseline in MDS-UPDRS Part II Score | Baseline, 6, and 12 months after MRgFUS treatment | MDS-UPDRS Part II assesses motor experiences of daily living. Range 0-52, with higher scores indicating worse symptoms. | ClinicalTrials.gov |
| Secondary | Change From Baseline in MDS-UPDRS Part IV Score | Baseline, 6, and 12 months after MRgFUS treatment | MDS-UPDRS Part IV assesses motor complications including fluctuations and dyskinesias. Range 0-24; higher scores indicate more severe motor complications. | ClinicalTrials.gov |
| Secondary | Change From Baseline in Contralateral Limb CRST Score | Baseline, 6, and 12 months after MRgFUS treatment | Sum of CRST items specific to limbs contralateral to the treated hemisphere, according to the prespecified CRST item mapping; higher scores indicate worse tremor. The exact item list and subscore range must be specified in the final scoring charter. | ClinicalTrials.gov |
| Secondary | Change From Baseline in Levodopa Equivalent Daily Dose | Baseline, 6, and 12 months after MRgFUS treatment | Total levodopa equivalent daily dose (LEDD), expressed in mg/day, calculated from all prescribed antiparkinsonian medicines using a prespecified conversion convention. | ClinicalTrials.gov |
| Secondary | Desirability of Outcome Ranking (DOOR) at 12 Months | 12 months after MRgFUS treatment | Participant-level composite benefit-risk ranking (DOOR) based on efficacy and adverse-event outcomes. The ordered outcome categories, handling of death and missing information, and comparison statistic must be finalized prospectively in the statistical analysis plan. | ClinicalTrials.gov |
| Secondary | Proportion of Participants With Persistent Procedure-Related Adverse Events at 12 Months | From MRgFUS treatment through 12 months after treatment | Number and percentage of treated participants with one or more adverse events judged related to MRgFUS that remain present at month 12; this is the key safety endpoint. | ClinicalTrials.gov |
| Secondary | Incidence, Severity and Duration of Treatment-Emergent Adverse Events | During MRgFUS and up to 12 months after treatment | Number and percentage of participants with adverse events during the procedure, 1-3 days afterward and later through month 12; severity, causality and resolution are recorded. Events of special interest include gait/balance changes, dysarthria, dysphagia, paresthesia, weakness, memory problems and somnolence. | ClinicalTrials.gov |
| Secondary | Change From Baseline in Montreal Cognitive Assessment Score | Baseline, 6, and 12 months after MRgFUS treatment | Montreal Cognitive Assessment (MoCA) total score, 0-30, with higher scores indicating better cognitive performance. | ClinicalTrials.gov |
| Secondary | Change From Baseline in Hospital Anxiety and Depression Scale Scores | Baseline, 6, and 12 months after MRgFUS treatment | Hospital Anxiety and Depression Scale (HADS) anxiety and depression subscales, each 0-21, with higher scores indicating greater symptom severity. Separate anxiety and depression results will be reported. | ClinicalTrials.gov |
| Other | Stereotactic Targeting Accuracy on Postoperative MRI | Preoperative planning and postoperative MRI at 1-3 days after MRgFUS | Euclidean distance (mm) between the planned geometric lesion center and the postoperative lesion center, with signed displacement along each stereotactic axis. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
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 |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.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.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)