Use of Interventional MRI for Implantation of Deep Brain Stimulator Electrodes

NCT00792532 | Completed FDA Device

• 1 other identifier: iMRI
• Study Type: observational
• Target: 8
• Locations: 1 country
• Sites: 1

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 scanner ("interventional MRI", or iMRI). With this surgical technique, the patient is fully asleep (under general anesthesia) during DBS implantation. 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. With the iMRI technique, 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.

Conditions

Parkinson's Disease; Dystonia

Outcome Measures

Primary Outcomes (2)

• 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.

  12 months post-surgery

• Dystonia: The percent change from baseline in the Burk-Fahn-Marsden Dystonia rating scale movement subscore to the 12 month postoperative subscore

  12 months post-surgery

Study Arms (1)

iMRI

Procedure: interventional MRI for implantation of DBS electrodes; Device: DBS electrodes

Interventions

interventional MRI for implantation of DBS electrodes PROCEDURE

DBS implantation will be performed entirely within a Phillips 3T MRI scanner

Also known as: interventional MR

iMRI

DBS electrodes DEVICE

Deep brain stimulation (DBS) electrodes

iMRI

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Parkinson's disease, eligible for DBS

You may qualify if:

• 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.

You may not qualify if:

• 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 diagnosed by a movement disorders neurologist
• Significant functional impairment despite optimal medical management, including failed botulinum toxin therapy if appropriate

Sponsors & Collaborators

• University of California, San Francisco: lead
• MRI Interventions, Inc.: collaborator

Study Sites (1)

San Francisco VA Medical Center

San Francisco, California, 94121, United States

Location

Related Publications (3)

• Martin AJ, Larson PS, Ostrem JL, Keith Sootsman W, Talke P, Weber OM, Levesque N, Myers J, Starr PA. Placement of deep brain stimulator electrodes using real-time high-field interventional magnetic resonance imaging. Magn Reson Med. 2005 Nov;54(5):1107-14. doi: 10.1002/mrm.20675.

  PMID: 16206144 RESULT

• Ostrem JL, Ziman N, Galifianakis NB, Starr PA, Luciano MS, Katz M, Racine CA, Martin AJ, Markun LC, Larson PS. Clinical outcomes using ClearPoint interventional MRI for deep brain stimulation lead placement in Parkinson's disease. J Neurosurg. 2016 Apr;124(4):908-16. doi: 10.3171/2015.4.JNS15173. Epub 2015 Oct 23.

  PMID: 26495947 DERIVED

• Starr PA, Markun LC, Larson PS, Volz MM, Martin AJ, Ostrem JL. Interventional MRI-guided deep brain stimulation in pediatric dystonia: first experience with the ClearPoint system. J Neurosurg Pediatr. 2014 Oct;14(4):400-8. doi: 10.3171/2014.6.PEDS13605. Epub 2014 Aug 1.

  PMID: 25084088 DERIVED

MeSH Terms

Conditions

Parkinson Disease; Dystonia

Interventions

Magnetic Resonance Imaging, Interventional

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2008
• First Posted: November 18, 2008
• Study Start: July 1, 2003
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2019
• Last Updated: December 18, 2019

Record last verified: 2019-12

Locations

US (1)