Trial record 1 of 1 for:    NCT00792532
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Use of Interventional MRI for Implantation of Deep Brain Stimulator Electrodes (iMRI)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by University of California, San Francisco
Sponsor:
Collaborator:
MRI Interventions, Inc.
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00792532
First received: November 14, 2008
Last updated: June 3, 2014
Last verified: June 2014
  Purpose

The purpose of this study is to determine the safety and effectiveness of a new procedure for placing DBS electrodes, in which the entire surgery is performed within an MRI scanner ("interventional MRI"), with the patient fully asleep (under general anesthesia). The standard method for the placement of deep brain stimulators does not use MRI during the actual DBS placement. The standard method involves placement of a rigid frame on the patient's head, performance of a short MRI scan, transport to the operating room, placement of the DBS electrodes in the operating room, and return to the MRI suite for another MR to confirm correct electrode placement. In the standard method, the patient must be awake for 2-4 hours in the operating room to have "brain mapping" performed, where the brain target is confirmed by passing "microelectrodes" (thin wires) into the brain to record its electrical activity. In the standard method, general anesthesia is not required. In this study, the surgery is guided entirely by MRI images performed multiple times as the DBS electrode is advanced. This eliminates the need for the patient to be awake, and eliminates the need for passing microelectrodes into the brain before placing the permanent DBS electrode.


Condition Intervention Phase
Parkinson's Disease
Dystonia
Procedure: interventional MRI for implantation of DBS electrodes
Device: DBS electrodes
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Use of Interventional MRI for Implantation of Deep Brain Stimulator Electrodes

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Parkinson's disease: The degree of benefit from baseline off medication UPDRS(part III) motor score to postoperative off medication scores at 12 months with stimulation on. [ Time Frame: 12 months post-surgery ] [ Designated as safety issue: No ]
  • Dystonia: The percent change from baseline in the Burk-Fahn-Marsden Dystonia rating scale movement subscore to the 12 month postoperative subscore [ Time Frame: 12 months post-surgery ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: July 2003
Estimated Study Completion Date: July 2018
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: iMRI Procedure: interventional MRI for implantation of DBS electrodes
DBS implantation will be performed entirely within a Phillips 3T MRI scanner
Other Name: interventional MR
Device: DBS electrodes
Deep brain stimulation (DBS) electrodes

Detailed Description:

Deep brain stimulation (DBS) is a new but increasingly common surgical technique for the treatment of Parkinson's disease and dystonia. The current technical approach to DBS implantation involves frame-based stereotaxy. In this method, a stereotactic frame is rigidly fixed to the patient's skull, an MRI is obtained, an anatomic target is identified, and the coordinates of the target in stereotactic space are calculated. Instruments are mounted on the stereotactic frame that point to the calculated coordinate. However, due to the inherent inaccuracies in standard frame-based stereotaxy, a complex 6-hour procedure then ensues to "map" the brain target with microelectrodes, place the lead, and return to the MR unit to confirm proper placement.

The goal of this project is to test the feasibility of performing DBS implantation entirely within the Phillips 3T open magnet MRI machine. Prior to study initiation, instrumentation and MR protocols were tested using a phantom head. In the proposed project, subthalamic nucleus or Globus Pallidus DBS implantations will be performed bilaterally in patients with Parkinson's disease or dystonia. Patients will be under general anesthesia. Targeting and lead verification are performed with imaging alone, without physiologic mapping. Data is to be gathered on the following: Operative time, degree of benefit with bilateral implantation (changes in standard rating scales of motor disability), DBS voltage requirements, complications), and electrode location by MR. These measures will be compared with our historical controls, previously entered into our research database, in which electrodes were placed by the standard methods. We expect that the use of near real time MR will improve the speed and accuracy of DBS implantation, and eliminate the need for invasive physiological monitoring.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Parkinson's Disease

Inclusion Criteria:

  1. 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.
  2. Approximately 5 years' duration, relative to the date of surgery, since diagnosis of PD.
  3. Age >20 inclusive, on date of surgery.
  4. The subject is ambulatory in their best on time (not wheelchair bound).
  5. 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).
  6. The subject is expected to be able to comply with and understand the required visit schedule and all required tests and procedures.
  7. Signed IRB-approved informed consent is obtained before any study-specific procedure, including assessments required during the eligibility evaluation period.

Exclusion Criteria:

  1. 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.
  2. History of treatment of PD by any procedure involving intracranial surgery or implantation of a device.
  3. 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).
  4. Any disorder that precludes a surgical procedure (e.g., signs of sepsis or inadequately treated infection) or alters wound healing.
  5. Receipt of antiplatelet agents for at least 10 days prior surgery.
  6. A score of less than or equal to 24 on the Folstein Mini-Mental examination performed during the eligibility evaluation period.
  7. History of significant psychiatric illness, epilepsy, or Alzheimer's disease.
  8. Active drug or alcohol abuse.
  9. Pregnancy or lack of effective contraception in women of childbearing potential defined as one year post-menopausal or surgically sterile.
  10. Treatment with nonanti-Parkinsonian agents (e.g., atypical neuroleptics) that may affect symptoms of PD within 60 days before entering the study.
  11. 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.
  12. Inability to follow-up with post-operative study visits
  13. Inability to speak or read English

Dystonia Inclusion Criteria

  1. Dystonia diagnosed by a movement disorders neurologist
  2. Significant functional impairment despite optimal medical management, including failed botulinum toxin therapy if appropriate
  3. Age >20 years inclusive, on date of surgery.
  4. 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).
  5. The subject is able to comply with and understand the required visit schedule and all required tests and procedures.
  6. Signed IRB-approved informed consent is obtained before any study-specific procedure, including assessments required during the eligibility evaluation period.

Exclusion Criteria

  1. Any disorder that precludes a surgical procedure (e.g., signs of sepsis or inadequately treated infection) or alters wound healing.
  2. Receipt of antiplatelet agents for at least 10 days prior surgery.
  3. A score of less than or equal to 24 on the Folstein Mini-Mental examination performed during the eligibility evaluation period.
  4. History of significant psychiatric illness, epilepsy, or Alzheimer's disease.
  5. Active drug or alcohol abuse.
  6. Pregnancy or lack of effective contraception in women of childbearing potential defined as one year post-menopausal or surgically sterile.
  7. 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.
  8. Inability to follow-up with post-operative study visits
  9. Inability to speak or read English
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00792532

Locations
United States, California
San Francisco VA Medical Center Recruiting
San Francisco, California, United States, 94121
Contact: Maya Katz, MD    415-379-5530    maya.katz@ucsfmedctr.org   
Contact: Mary McCormack    415-379-5530    Mary.McCormack@va.gov   
Principal Investigator: Paul Larson, MD         
Sub-Investigator: Maya Katz, MD         
Principal Investigator: Philip A. Starr, MD, PhD         
Sponsors and Collaborators
University of California, San Francisco
MRI Interventions, Inc.
Investigators
Principal Investigator: Philip Starr, M.D., Ph.D. University of California, San Francisco; SFVAMC
Principal Investigator: Paul Larson, M.D. University of California, San Francisco; SFVAMC
Principal Investigator: Jill L Ostrem, MD University of California San Francisco, SFVAMC
Principal Investigator: Alastair J Martin, PhD University of California, San Francisco
  More Information

Publications:
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00792532     History of Changes
Other Study ID Numbers: iMRI
Study First Received: November 14, 2008
Last Updated: June 3, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Dystonia
Dystonic Disorders
Parkinson Disease
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Movement Disorders
Central Nervous System Diseases
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on July 24, 2014