CompletedNot Applicable

ExAblate Transcranial MRgFUS of the Subthalamic Nucleus for Treatment of Parkinson's Disease

United States7 participantsStarted 2014-09

Plain-language summary

This is primarily a safety protocol to evaluate the safety of subthalamotomy using Transcranial ExAblate for treatment of Parkinson's Disease (PD) motor features.

Who can participate

Age range30 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Men and women, age 30 years and older
✓. Subjects who are able and willing to give informed consent and able to attend all study visits
✓. Subjects with a diagnosis of idiopathic PD by UK Brain Bank Criteria as confirmed by a movement disorder neurologist at the site
✓. Levodopa responsive as defined by at least a 30% reduction in MDS-UPDRS motor sub-scale in the ON vs OFF medication state
✓. Disabling motor clinical features not optimally controlled by an adequate medication prescription. An adequate medication prescription is defined as a therapeutic dose of each medication or the development of side effects as the medication dose is titrated
✓. Predominant disability from one side of the body (i.e unilateral or markedly asymmetric disease) as determined by movement disorders neurologist and neurosurgeon
✓. Subjects should be on a stable dose of all PD medications for 30 days prior to study entry
✓. Subthalamic nucleus is visible on MRI so that it can be targeted by the ExAblate device

Exclusion criteria

✕. Hoehn and Yahr stage in the ON medication state of 2.5 or greater
✕. Presence of severe dyskinesia as noted by a score of 3 or 4 on questions 4.1 and 4.2 of the MDS-UPDRS
✕. Presence of other central neurodegenerative disease suspected on neurological examination. These include: multisystem atrophy, progressive supranuclear palsy, corticobasal syndrome, dementia with Lewy bodies, and Alzheimer's disease
✕. Any suspicion that Parkinsonian symptoms are a side effect from neuroleptic medications
✕. Subjects who have had deep brain stimulation or a prior stereotactic ablation of the basal ganglia
✕. Presence of significant cognitive impairment defined as score ≤ 21 on the Montreal Cognitive Assessment (MoCA) or Mattis Dementia Rating Scale of 120 or lower
✕. Unstable psychiatric disease, defined as active uncontrolled depressive symptoms, psychosis, delusions, hallucinations, or suicidal ideation. Subjects with stable, chronic anxiety or depressive disorders may be included provided their medications have been stable for at least 60 days prior to study entry and if deemed appropriately managed by the site neuropsychologist
✕. Subjects with significant depression as determined following a comprehensive assessment by a neuropsychologist. Significant depression is being defined quantitatively as a score of greater than 14 on the Beck Depression Inventory

What they're measuring

Incidence and severity of adverse events

Timeframe: Baseline to 4 months post treatment

Mean change in MDS-UPDRS Part III scores

Timeframe: Baseline to 4 months post treatment

Trial details

NCT IDNCT02246374

SponsorInSightec

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-05

View on ClinicalTrials.gov More Parkinson's Disease trials