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

Parkinson's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01563341
• Other study ID #: 11-007086
• Status: Completed
• Phase: N/A
• Start date: April 2012
• Est. completion date: October 18, 2023

Study information

• Verified date: May 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: October 18, 2023
• Est. primary completion date: October 18, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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.

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Deep Brain Stimulation
• Parkinson Disease
• Parkinson's Disease

Intervention

Device:
• Deep brain stimulation
Study will be utilizing multiple brain electrodes simultaneously. The study will require at least two electrodes to be placed in one cerebral hemisphere (one for motor improvement and one for potential cognitive implications).

Locations

Country	Name	City	State
United States	Mayo Clinic in Florida	Jacksonville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in memory testing from presurgical baseline to 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, in any order. 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 (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".	baseline, 12 months

External Links

•   Mayo Clinic Clinical Trials