Tandem DBS for Parkinson's Disease: A Pilot Study Utilizing STN/GPi + Hypothalamic Stimulation

Not Applicable

Completed

• Conditions: Deep Brain Stimulation; Parkinson's Disease
• Interventions: Device: Deep brain stimulation

• Registration Number: NCT01563341
• Lead Sponsor: Mayo Clinic

Brief Summary

Does dual hemispheric stimulation of the subthalamic nucleus (STN) and fornix/hypothalamus potentially improve cognitive function in patients with Parkinsons disease.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-03-20
• Study First Submitted QC: 2012-03-23
• Study First Posted: 2012-03-26
• Study Start: 2012-04
• Primary Completion: 2023-10-18
• Study Completion: 2023-10-18
• Results First Submitted: 2024-09-06
• Status Verified: 2024-12
• Results First Submitted QC: 2024-12-19
• Last Update Submitted: 2024-12-19
• Results First Posted: 2024-12-27
• Last Update Posted: 2024-12-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

• All patients will be enrolled from the practice of the primary investigator.
• Parkinson's Disease (PD) patients in whom optimal medical therapy has failed.
• All patients will have responsivity to levodopa.
• Individuals with normal or mild cognitive impairment.

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Exclusion Criteria

• Clinically significant dementia
• Other significant neurological or psychiatric disease
• Previous brain surgery including pallidotomy or thalamotomy
• Previous placement of other implantable devices

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Deep Brain Stimulation	Deep brain stimulation	Parkinson's disease patients who would otherwise be undergoing subthalamic nucleus (STN) deep brain stimulation (DBS) will have dual hemispheric stimulation of the STN and globus pallidus interna (GPi).

Primary Outcome Measures

Name	Time	Method
Change in Memory Testing From Presurgical Baseline to 12 Months	baseline, 12 months	Memory will be assessed with the Hopkins Verbal Learning Test. The test consists of a set of six forms. Each test includes a list of 12 nouns; the examiner reads the list to the examinee, who repeats as many words as remembered. This process is repeated three times; 20-25 minutes later, examinees are asked again to recall as many words as possible; for the final task, the examiner reads a list of 24 words (including the 12 words from the list) and asks the examinee after each whether the word was on the list. For interpreting findings, in each metric listed on a scale from 0 to 12 with zero being worse and 12 being best (total recall, delayed recall, retention), higher scores reflect better learning efficiency (total recall) and memory (delayed recall, retention). Since this is a longitudinal study, follow-up scores will be compared to baseline. A positive direction of change would be interpreted as "improved" and a negative direction of change would be interpreted as "declined".

Trial Locations

Locations (1)

Mayo Clinic in Florida; 🇺🇸 Jacksonville, Florida, United States