MER Versus MRI Guidance DBS in Parkinson's Disease

NCT01883973 | Completed

• 1 other identifier: H-27630
• Study Type: observational
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

Most leading academic centers including Baylor College of Medicine (BCM) perform deep brain stimulation surgery in the awake patient using microelectrode recording to guide final electrode placement. Microelectrode recording is a means of analyzing the electrical activity of the brain, and assessing whether we have found the target for the deep brain stimulator electrode. However, no evidence exists that microelectrode recording improves patient outcomes. The use of microelectrode recording does extend the duration of surgery and there is evidence to suggest that microelectrode recording may increase the risk of bleeding in the brain during surgery.

Conditions

Idiopathic Parkinson's Disease (PD)

Keywords

PD; DBS

Outcome Measures

Primary Outcomes (1)

• percentage improvement in the UPDRS part III motor score

  The primary outcome measure for this study is the percentage improvement in the Unified Parkinson Disease Rating Scale (UPDRS) part III motor score from baseline to 6 months in patients who receiving stimulation in the "OFF" medication state. Secondary outcome measures include rate of radiographically visible intracranial hemorrhage and changes in neurocognitive function and quality of life testing. The student's two sample t-test will be used to perform the statistically comparisons.

  from baseline to 6 months

Study Arms (2)

MER guidance

Will undergo DBS implantation in the awake state using a frame based stereotactic technique and intraoperative microelectrode recording to guide final lead placement.

MRI Guidance

Will undergo DBS implantation under general anesthesia using anatomical targeting in an operating room equipped with an intraoperative MRI to guide electrode placement

Eligibility Criteria

• Age: 30 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients between the ages of 30 and 79 Diagnosis of idiopathic Parkinson's disease

You may qualify if:

• Determined to be candidates for subthalamic nucleus (STN) or Globus pallidus (GPi) DBS by consensus recommendation of a multidisciplinary team as evidenced by:
• Ability to provide informed consent as determined by preoperative neuropsychological assessment
• Optimized medically by a neurologist who is an expert in the treatment of movement disorders.
• Persistent motor symptoms which are not effectively controlled with optimal medical management. These symptoms may include levodopa-induced dyskinesias, tremor, or fluctuations in the effectiveness of levodopa throughout the day.

You may not qualify if:

• Dementia
• Previous intracranial surgery
• Intracranial tumor
• Lack of ability to provide informed consent as determined by preoperative neuropsychological assessment
• Medical co-morbidities that would make the patient a poor surgical candidate

Sponsors & Collaborators

• Baylor College of Medicine: lead

Study Sites (1)

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Ashwin Viswanathan, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

• Joohi Jimenez-Shahed, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 19, 2013
• First Posted: June 21, 2013
• Study Start: May 1, 2011
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: November 25, 2020

Record last verified: 2020-11

Locations

US (1)