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

Mayo Clinic

Status: Completed

Conditions: Parkinson's Disease; Deep Brain Stimulation

Treatments: Device: Deep brain stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT01563341

11-007086

Details and patient eligibility

About

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

Enrollment: 5 patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 1 patient group

Deep Brain Stimulation

Experimental group

Description:

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).

Treatment:

Device: Deep brain stimulation