ExAblate Transcranial MR Guided Focused Ultrasound for the Treatment of Parkinson's Disease
17 september 2020 bijgewerkt door: InSightec
A Feasibility Study to Evaluate Safety and Initial Effectiveness of ExAblate Transcranial MR Guided Focused Ultrasound for Unilateral Thalamotomy in the Treatment of Medication-Refractory Tremor Dominant Idiopathic Parkinson's Disease.
This is a feasibility study to evaluate the safety and initial effectiveness of unilateral ExAblate thermal ablation of the Vim thalamic nucleus of subjects suffering from medication-refractory, idiopathic, tremor-dominant PD, using the ExAblate Transcranial system compared to a Sham Vim thalamotomy procedure.
Data will be collected to establish the basic safety of this type of treatment as the basis for later studies that will evaluate its full clinical efficacy. The Sham treatment data will be used to evaluate placebo effect from treatment.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
Subjects who sign informed consent and pass all eligibility criteria will be randomized to a treatment assignment.
During treatment, the assigned treatment (ExAblate Transcranial or Sham ExAblate Transcranial)will be delivered.
Subjects are followed in a blinded fashion for three (3) months.
After the 3-month assessment, subjects will be unblinded and told their treatment assignment.
Subjects receiving Sham ExAblate Transcranial treatment who still meet criteria will be crossed over and receive an active ExAblate Transcranial treatment.
Subjects will be followed for up to two (2) years.
Follow-up at 1 week, 1 month, 3 months, 6 months, 9 months, 12 months and up to two (2) years includes Unified Parkinson's Disease Rating Scale (UPDRS) scoring, mental and cognitive functional testing and questionnaires.
Studietype
Ingrijpend
Inschrijving (Werkelijk)
27
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Virginia
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Charlottesville, Virginia, Verenigde Staten, 22908
- University of Virginia
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Washington
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Seattle, Washington, Verenigde Staten, 98122
- Swedish Medical Center
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
30 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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 as confirmed from clinical history and examination by a movement disorder neurologist at the site
- Subject demonstrates a severe resting tremor or postural/action as measured by UPDRS
- Subject exhibits a significant disability from their PD tremor despite medical treatment
- Subjects should be on a stable dose of all PD medications for 30 days prior to study entry
- Subject is able to communicate sensations during the ExAblate Transcranial procedure
Exclusion Criteria:
- Subjects with unstable cardiac status
- Subjects exhibiting any behavior(s) consistent with ethanol or substance abuse
- Severe hypertension
- Subjects with standard contraindications for MR imaging such as non-MRI compatible implanted metallic devices including cardiac pacemakers, size limitations, etc.
- Known intolerance or allergies to the MRI contrast agent including advanced kidney disease or severely impaired renal function
- Significant claustrophobia that cannot be managed with mild medication
- Current medical condition resulting in abnormal bleeding and/or coagulopathy
- Receiving anticoagulant (e.g. warfarin) or antiplatelet (e.g. aspirin) therapy within one week of focused ultrasound procedure or drugs known to increase risk or hemorrhage
- History of intracranial hemorrhage
- History of multiple strokes, or a stroke within past 6 months
- Subjects who are not able or willing to tolerate the required prolonged stationary supine position during treatment
- Are participating or have participated in another clinical trial in the last 30 days
- Subjects unable to communicate with the investigator and staff
- Subjects with a history of seizures within the past year
- Subjects with brain tumors
- Subjects with intracranial aneurysms requiring treatment or arterial venous malformations (AVMs) requiring treatment
- Subjects who have had deep brain stimulation or a prior stereotactic ablation of the basal ganglia
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: ExAblate Transcranial MRgFUS
ExAblate Transcranial MR guided Focused Ultrasound
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ExAblate Transcranial MR Guided Focused Ultrasound
Andere namen:
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Sham-vergelijker: Sham ExAblate Transcranial MRgFUS
Sham treatment with ExAblate MR guided Focused Ultrasound
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Sham ExAblate Transcranial MR Guided Focused Ultrasound
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Number of Adverse Events
Tijdsspanne: Month 3
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Evaluate of adverse events (AEs) associated with the ExAblate Transcranial thalamotomy of medication-refractory, tremor-dominant PD during the ExAblate treatment. Primary safety analyses are reported in the adverse events module. |
Month 3
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Tremor Motor Score Percent Change From Baseline.
Tijdsspanne: Baseline, Month 3
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The percent change from baseline to Month 3 follow-up in upper extremity Tremor-Motor scores for the treated side is a sub-scale of Clinical Rating Scale for Tremor (CRST) Part A and Part B sum that was used to measure treated-side upper extremity tremor changes over time.
Tremor-motor scores range from 0-32 points.
Individual subject's scores at Baseline and 3 Months were used to calculate percent change from baseline and averaged across subjects.
High percent change from baseline is better (shows improvement).
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Baseline, Month 3
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Tremor Motor Scores - Clinical Rating Scale for Tremor - Treated Side Upper Extremity Parts A & B.
Tijdsspanne: Baseline, Month 3, Month 12
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Upper extremity Tremor-Motor score for the treated side is a sub-scale of Clinical Rating Scale for Tremor (CRST) Part A and Part B sum that measures treated-side upper extremity tremor changes over time.
Tremor-motor scores range from 0-32 points for each side with lower scores being a better outcome.
Subject's Tremor-Motor scores for the test and sham control groups were averaged at each study visit.
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Baseline, Month 3, Month 12
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Functional Disabilities - Clinical Rating Scale for Tremor Part C - Functional Disabilities
Tijdsspanne: Baseline, Month 3, Month 12
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The Clinical Rating Scale for Tremor (CRST) Part C is a measure of functional disability due to tremor.
The Clinical Rating Scale for Tremor Part C consists of 8 items each scored from 0 to 4. Thus, the total score summed ranges from 0 to 32 and provides an overall assessment of activities of daily living.
Low scores on the Clinical Rating Scale for Tremor (CRST) Part C are better.
Low scores show improvement in functional disabilities compared to higher scores.
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Baseline, Month 3, Month 12
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Hoofdonderzoeker: Jeff Elias, M.D., University of Virginia
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
1 september 2012
Primaire voltooiing (Werkelijk)
26 april 2016
Studie voltooiing (Werkelijk)
1 maart 2019
Studieregistratiedata
Eerst ingediend
28 november 2012
Eerst ingediend dat voldeed aan de QC-criteria
18 januari 2013
Eerst geplaatst (Schatting)
21 januari 2013
Updates van studierecords
Laatste update geplaatst (Werkelijk)
9 oktober 2020
Laatste update ingediend die voldeed aan QC-criteria
17 september 2020
Laatst geverifieerd
1 juli 2020
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- PD001
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