CompletedNot Applicable

Safety and Initial Effectiveness of Transcranial MR Guided Focused Ultrasound for the Treatment of Parkinson's Disease

Japan10 participantsStarted 2017-02-06

Plain-language summary

Safety and Effectiveness in ExAblate Neuro treatment of medication-refractory tremor in subjects with idiopathic Parkinson's disease.

Age range30 Years

SexALL

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

✓. 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 through 3 Months
✓. Subjects with a diagnosis of idiopathic PD as confirmed from clinical history and examination by a movement disorder neurologist at the site
✓. All subjects included in this study will have a TD/PIGD ratio \> 1.15 in the medicated \[ON\] state as calculated from the UPDRS formula as described by S, et. al., \[74\].
✓. Subject demonstrates a resting tremor severity score of greater than or equal to 3 in the hand/arm as measured by the medicated (ON) MDS-UPDRS question 3.17 or a postural/action tremor greater than or equal to a 2 for question 3.15 or 3.16.
✓. Significant disability due to PD tremor despite medical treatment (CRST score of 2 or above in any one of the items 16-23 from the Disability subsection of the CRST: \[speaking, feeding other than liquids, bringing liquids to mouth, hygiene, dressing, writing, working, and social activities\])
✓. Tremor remains disabling when medical therapy is optimal or not tolerated for the treatment of other cardinal signs of PD (bradykinesia, rigidity, etc), as determined by a movement disorders neurologist at the site
✓. Subjects should be on a stable dose of all PD medications for 30 days prior to study entry.

✕. Subjects with unstable cardiac status including:
✕. Unstable angina pectoris on medication
✕. Subjects with documented myocardial infarction within six months of protocol entry
✕. Significant congestive heart failure defined with ejection fraction \< 40
✕. Subjects with unstable ventricular arrhythmias
✕. Subjects with atrial arrhythmias that are not rate-controlled
✕. Subjects exhibiting any behavior(s) consistent with ethanol or substance abuse as defined by the criteria outlined in the DSM-IV as manifested by one (or more) of the following occurring within the preceding 12 month period:
✕. Recurrent substance use resulting in a failure to fulfill major role obligations at work, school, or home (such as repeated absences or poor work performance related to substance use; substance-related absences, suspensions, or expulsions from school; or neglect of children or household).

Clinical Rating Scale for Tremor

Timeframe: 3 Months after Treatment

Severity of Device and Procedure related complications

Timeframe: 1 year

NCT IDNCT04002596

SponsorInSightec

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-12-05

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.

✓. 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 through 3 Months
✓. Subjects with a diagnosis of idiopathic PD as confirmed from clinical history and examination by a movement disorder neurologist at the site
✓. All subjects included in this study will have a TD/PIGD ratio \> 1.15 in the medicated \[ON\] state as calculated from the UPDRS formula as described by S, et. al., \[74\].
✓. Subject demonstrates a resting tremor severity score of greater than or equal to 3 in the hand/arm as measured by the medicated (ON) MDS-UPDRS question 3.17 or a postural/action tremor greater than or equal to a 2 for question 3.15 or 3.16.
✓. Significant disability due to PD tremor despite medical treatment (CRST score of 2 or above in any one of the items 16-23 from the Disability subsection of the CRST: \[speaking, feeding other than liquids, bringing liquids to mouth, hygiene, dressing, writing, working, and social activities\])
✓. Tremor remains disabling when medical therapy is optimal or not tolerated for the treatment of other cardinal signs of PD (bradykinesia, rigidity, etc), as determined by a movement disorders neurologist at the site
✓. Subjects should be on a stable dose of all PD medications for 30 days prior to study entry.

✕. Subjects with unstable cardiac status including:
✕. Unstable angina pectoris on medication
✕. Subjects with documented myocardial infarction within six months of protocol entry
✕. Significant congestive heart failure defined with ejection fraction \< 40
✕. Subjects with unstable ventricular arrhythmias
✕. Subjects with atrial arrhythmias that are not rate-controlled
✕. Subjects exhibiting any behavior(s) consistent with ethanol or substance abuse as defined by the criteria outlined in the DSM-IV as manifested by one (or more) of the following occurring within the preceding 12 month period:
✕. Recurrent substance use resulting in a failure to fulfill major role obligations at work, school, or home (such as repeated absences or poor work performance related to substance use; substance-related absences, suspensions, or expulsions from school; or neglect of children or household).