Status:
COMPLETED
Use of Interventional MRI for Implantation of Deep Brain Stimulator Electrodes
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
MRI Interventions, Inc.
Conditions:
Parkinson's Disease
Dystonia
Eligibility:
All Genders
21+ years
Brief Summary
The purpose of this study is to gather observational data on an already FDA-approved implantation technique for deep brain stimulation (DBS) in which the entire surgery is performed within an MRI scan...
Detailed Description
Deep brain stimulation (DBS) is an increasingly common surgical technique for the treatment of Parkinson's disease and dystonia. The current technical approach to DBS implantation involves frame-based...
Eligibility Criteria
Inclusion
- Parkinson's Disease
- Diagnosis of idiopathic PD with clinically significant motor fluctuations despite maximized anti-Parkinsonian therapy. This will be based on medical history, neurologic examination (the presence of at least 2 of the following: resting tremor, rigidity, or bradykinesia), and response to anti-Parkinsonian therapy.
- Approximately 5 years' duration, relative to the date of surgery, since diagnosis of PD.
- Age \>20 inclusive, on date of surgery.
- The subject is ambulatory in their best on time (not wheelchair bound).
- The subject is medically able to undergo the surgery as determined by clinical and laboratory evaluations and any other evaluations that are part of the standard practice at the institution in which the subject is to undergo surgery (e.g., subjects will have normal coagulation tests and normal platelet levels).
- The subject is expected to be able to comply with and understand the required visit schedule and all required tests and procedures.
- Signed IRB-approved informed consent is obtained before any study-specific procedure, including assessments required during the eligibility evaluation period.
Exclusion
- In the judgment of the investigator, a history of any clinically significant medical, psychiatric, or laboratory abnormality for which participation in the study would pose a safety risk to the subject.
- History of treatment of PD by any procedure involving intracranial surgery or implantation of a device.
- MRI of the brain within 12 months before the surgery which demonstrates an intracranial abnormality that would contraindicate surgery (e.g. stroke, tumor, vascular abnormality affecting the DBS target area).
- Any disorder that precludes a surgical procedure (e.g., signs of sepsis or inadequately treated infection) or alters wound healing.
- Receipt of antiplatelet agents for at least 10 days prior surgery.
- Significant cognitive impairment based on investigator assessment during the eligibility evaluation period.
- History of significant psychiatric illness, epilepsy, or Alzheimer's disease.
- Active drug or alcohol abuse.
- Pregnancy or lack of effective contraception in women of childbearing potential defined as one year post-menopausal or surgically sterile.
- Treatment with non anti-Parkinsonian agents (e.g., atypical neuroleptics) that may affect symptoms of PD within 60 days before entering the study.
- Any medical disability (e.g., severe degenerative arthritis, compromised nutritional state, severe peripheral neuropathy) that would interfere with the assessment of safety and efficacy in this trial.
- Inability to follow-up with post-operative study visits
- Inability to speak or read English
- Dystonia Inclusion Criteria
- Dystonia diagnosed by a movement disorders neurologist
- Significant functional impairment despite optimal medical management, including failed botulinum toxin therapy if appropriate
- Age \>20 years inclusive, on date of surgery.
- The subject is medically able to undergo the surgery as determined by clinical and laboratory evaluations and any other evaluations that are part of the standard practice at the institution in which the subject is to undergo surgery (e.g., subjects will have normal coagulation tests and normal platelet levels).
- The subject is able to comply with and understand the required visit schedule and all required tests and procedures.
- Signed IRB-approved informed consent is obtained before any study-specific procedure, including assessments required during the eligibility evaluation period.
- Exclusion Criteria
- Any disorder that precludes a surgical procedure (e.g., signs of sepsis or inadequately treated infection) or alters wound healing.
- Receipt of antiplatelet agents for at least 10 days prior surgery.
- Significant cognitive impairment based on investigator assessment during the eligibility evaluation period.
- History of significant psychiatric illness, epilepsy, or Alzheimer's disease.
- Active drug or alcohol abuse.
- Pregnancy or lack of effective contraception in women of childbearing potential defined as one year post-menopausal or surgically sterile.
- Any medical disability (e.g., severe degenerative arthritis, compromised nutritional state, severe peripheral neuropathy) that would interfere with the assessment of safety and efficacy in this trial.
- Inability to follow-up with post-operative study visits
- Inability to speak or read English
Key Trial Info
Start Date :
July 1 2003
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 1 2019
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT00792532
Start Date
July 1 2003
End Date
March 1 2019
Last Update
December 18 2019
Active Locations (1)
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1
San Francisco VA Medical Center
San Francisco, California, United States, 94121