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Enzyme Replacement Therapy

MR-Guided Focused Ultrasound + GCase for Parkinson's Disease

N/A

Recruiting

Research Sponsored by InSightec

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

Study Summary

This trial tests a new, non-invasive way to treat Parkinson's disease using ultrasound and a protein called GCase. It may help improve symptoms.

Who is the study for?

This trial is for men and women aged 35-75 with Parkinson's Disease diagnosed at least 2 years ago, at stages 1-3 on medication. Participants must have a positive DAT SPECT scan, be on stable PD meds for over 90 days, and either carry a GBA mutation or not, depending on the study arm. Exclusions include pregnancy, severe kidney issues, other clinical trials participation, hypersensitivity to certain agents used in the study or MRI contrasts.Check my eligibility

What is being tested?

The trial tests if it's safe and doable to deliver GCase directly into the brain using MR-guided Focused Ultrasound (MRgFUS). This method has shown promise in animal studies for improving Parkinson’s symptoms by exposing part of the brain called putamen to GCase.See study design

What are the potential side effects?

Potential side effects are not detailed but may relate to MRgFUS procedure complications like discomfort or pain at the target site. There could also be reactions related to GCase delivery such as allergic responses or infusion-related reactions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Adverse Events

Secondary outcome measures

Feasibility of MRgFUS BBB opening for GCase brain delivery

Trial Design

2Treatment groups

Experimental Treatment

Group I: Idiopathic PD PatientsExperimental Treatment1 Intervention

Idiopathic PD patients receiving 3 cycles of BBBO paired with GCase Treatments

Group II: GBA PD PatientsExperimental Treatment1 Intervention

GBA PD patients receiving 3 cycles of BBBO paired with GCase Treatments

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

InSightecLead Sponsor

89 Previous Clinical Trials

3,700 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are any new participants still being welcomed into the experiment?

"Affirmative, the information on clinicaltrials.gov illustrates that this study is currently recruiting participants. This trial was originally advertised on November 30th 2022 and most recently updated on September 1st 2023. 14 patients need to be enrolled from one site in total."

Answered by AI

Are persons over the age of fifty eligible to enroll in this experiment?

"According to the eligibility criteria, individuals aged 35-75 are permitted to join this research. There is an additional 23 investigations targeting minors and 516 for seniors."

Answered by AI

How many participants are being enrolled in this experiment?

"Affirmative. Clinicaltrials.gov provides evidence that this medical trial, which was initially posted on November 30th 2022, is actively searching for subjects to join the experiment. Approximately 14 participants are needed from a single location."

Answered by AI

Who is eligible to enroll in this research trial?

"This clinical trial is seeking a cohort of 14 individuals, aged 35 to 75, who are currently diagnosed with Parkinson's disease. Additionally, potential participants must fulfil the following criteria: male or female; willing and able to offer informed consent; meet the Movement Disorder Society Clinical Diagnosis Criteria for PD; two years since initial diagnosis; Hoehn & Yahr Stage 1-3 on PD medication; Dopamine transporter (DAT) SPECT scan evidence of dopaminergic deficit; 90 days stable regimen of PD medications prior enrolment in study ; American Society of Anesthesiologists (ASA) score 1-3 and harbour"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

MR-guided Focused Ultrasound Plus GCase

2022. "MR-guided Focused Ultrasound Plus GCase". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05565443.

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