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Procedure
DBS of VIM and PSA for Essential Tremor
N/A
Waitlist Available
Led By Sana Aslam, DO
Research Sponsored by St. Joseph's Hospital and Medical Center, Phoenix
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 following two weeks of treatment at each intervention
Awards & highlights
Study Summary
This trial will study whether stimulating two areas of the brain at once is more effective in treating essential tremor than stimulating just one area.
Eligible Conditions
- Essential Tremor
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ following two weeks of treatment at each intervention
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~following two weeks of treatment at each intervention
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Stimulation-Induced Balance
Change in Stimulation-Induced Dysarthria
Change in Tremor Phenomenology
+1 moreTrial Design
3Treatment groups
Experimental Treatment
Group I: Group 3Experimental Treatment3 Interventions
Subjects will receive PSA stimulation for two weeks, followed by VIM stimulation for two weeks, and finally VIM+PSA stimulation for two weeks.
Group II: Group 2Experimental Treatment3 Interventions
Subjects will receive VIM+PSA stimulation for two weeks, followed by PSA stimulation for two weeks, and finally VIM stimulation for two weeks.
Group III: Group 1Experimental Treatment3 Interventions
Subjects will receive VIM stimulation for two weeks, followed by VIM+PSA stimulation for two weeks, and finally PSA stimulation for two weeks.
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Who is running the clinical trial?
St. Joseph's Hospital and Medical Center, PhoenixLead Sponsor
64 Previous Clinical Trials
14,646 Total Patients Enrolled
2 Trials studying Essential Tremor
5,000 Patients Enrolled for Essential Tremor
Sana Aslam, DOPrincipal InvestigatorSt Josephs Hospital and Medical Center
1 Previous Clinical Trials
11 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- Adults diagnosed with ET that hasn't improved with medication and are being considered for deep brain stimulation (DBS).You have a history of seizures.Adults with essential tremor that has not improved with medication and are being considered for deep brain stimulation.You have a mental illness.You cannot have surgery to place deep brain stimulation (DBS) leads on both sides of your brain.You have been diagnosed with dementia according to specific guidelines.You have tried to harm yourself in the past year.You have medical conditions that make it unsafe for you to have deep brain stimulation surgery, such as infections, blood clotting problems, or serious heart or other health issues that increase the risk of surgery.You have bleeding inside your brain.You have a medical condition that prevents you from having an MRI scan.You have a history of disease affecting the upper part of the spinal cord.You meet the requirements set by the FDA to be a deep brain stimulation (DBS) candidate.
Research Study Groups:
This trial has the following groups:- Group 1: Group 3
- Group 2: Group 2
- Group 3: Group 1
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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