Trial · NCT06584383
A Prospective, Randomized, Controlled Trial to Test Safety and Effectiveness of Unilateral Exablate MR-guided Focused Ultrasound Subthalamotomy in Patients With Early-Stage Parkinson's Disease
NCT06584383, Not applicable, Active not recruiting, InSightec
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Prospective, Randomized, Controlled Trial to Test Safety and Effectiveness of Unilateral Exablate MR-guided Focused Ultrasound Subthalamotomy in Patients With Early-Stage Parkinson's Disease. Trials, record NCT06584383. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06584383
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Prospective, Randomized, Controlled Trial to Test Safety and Effectiveness of Unilateral Exablate MR-guided Focused Ultrasound Subthalamotomy in Patients With Early-Stage Parkinson's Disease
- NCT number
- NCT06584383
- Status
- Active not recruiting
- Phases
- Not applicable
- Enrollment
- 67 participants, actual
- Lead sponsor
- InSightec
- Conditions
- Parkinson Disease
- Interventions
- Exablate MRgFUS subthalamotomy, Best Medical Treatment
- First posted
- 2024-09-04
- Last updated
- 2026-05-06
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | MDS-UPDRS Part III OFF Medication | 12 Months | Between-group difference (Exablate and control) in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III at 12 months in the off-medication state. |
| Secondary | PD-specific spatial covariance patterns (PDRP or PD related metabolic pattern) with brain 18F-fluorodeoxyglucose- Positron emission tomography | 12 Months | The metabolic pattern will be quantified to obtain a PDRP expression scores at baseline, 12-month and to compare disease evolution between groups. |
| Secondary | MDS-UPDRS III OFF-med video-based evaluation | 12 Months | Between group comparison (Exablate and control) through month 12 and within group comparison vs baseline month 12 in MDS-UPDRS III OFF-med video-based evaluation by a blinded movement disorders neurologist (only at baseline and 12 months). |
| Secondary | MDS-UPDRS I, II, III (ON and OFF meds) and UPDRS IV | 12 Months, 24 Months, 36 Months | Between group (Exablate and control) comparison through month 12 and within and between group (Exablate and comparator) comparison vs baseline, month 12 to 36 in MDS-UPDRS I, II, III (ON and OFF meds) and UPDRS IV. |
| Secondary | MDS Unified Dyskinesia Rating Scale | 12 Months, 24 Months, 36 Months | Between group (Exablate and control) comparison through month 12 and within and between group (Exablate and comparator) comparison vs baseline, month 12 to 36 in MDS Unified Dyskinesia Rating Scale. |
| Secondary | Quality of life assessment (PDQ39) | 12 Months, 24 Months, 36 Months | Between group (Exablate and control) comparison through month 12 and within and between group (Exablate and comparator) comparison vs baseline, month 12 to 36 in Quality-of-life assessment (PDQ39). |
| Secondary | Levodopa equivalent dose change usage (milligrams) | 12 Months, 24 Months, 36 Months | Between group (Exablate and control) comparison through month 12 and within and between group (Exablate and comparator) comparison vs baseline, month 12 to 36 in Levodopa equivalent dose usage (milligrams). |
| Secondary | MDS-Non motor rating scale | 12 Months, 24 Months, 36 Months | Between group (Exablate and control) comparison through month 12 and within and between group (Exablate and comparator) comparison vs baseline, month 12 to 36 in MDS-Non motor rating scale. |
| Secondary | Patient Global Impression of Change (PGIC) | 12 Months, 24 Months, 36 Months | Between group (Exablate and control) comparison through month 12 and within and between group (Exablate and comparator) comparison vs baseline, month 12 to 36 in Patient Global Impression of Change (PGIC). |
| Secondary | Clinician Global Impression of Change (CGIC) | 12 Months, 24 Months, 36 Months | Between group (Exablate and control) comparison through month 12 and within and between group (Exablate and comparator) comparison vs baseline, month 12 to 36 in Clinician Global Impression of Change (CGIC). |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 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.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
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/NCT06584383
GET https://conductscience.org/api/trials/v1/NCT06584383/registered