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

NCT01563341 | Completed Results FDA Device

• 1 other identifier: 11-007086
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Parkinson's Disease; Deep Brain Stimulation

Outcome Measures

Primary Outcomes (1)

• 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. 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".

  baseline, 12 months

Study Arms (1)

Deep Brain Stimulation

EXPERIMENTAL

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).

Device: Deep brain stimulation

Interventions

Deep brain stimulation DEVICE

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).

Deep Brain Stimulation

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Deep Brain Stimulation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Surgical Procedures, Operative

Results Point of Contact

• Title: Ryan J. Uitti, MD
• Organization: Mayo Clinic

uitti.ryan@mayo.edu

904-953-2000

Study Officials

• Ryan Uitti, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 20, 2012
• First Posted: March 26, 2012
• Study Start: April 1, 2012
• Primary Completion: October 18, 2023
• Study Completion: October 18, 2023
• Last Updated: December 27, 2024
• Results First Posted: December 27, 2024

Record last verified: 2024-12

Locations

US (1)