Closed Loop DBS Implanted RC+S Study

Part of paid clinical trials in Durham, North Carolina.

Sponsor
Dennis Turner, M.D.
Study ID
NCT03815656
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • STN alone — DEVICE
    DBS stimulation of STN alone
  • GPi alone — DEVICE
    DBS stimulation of GPi alone
  • STN + GPi — DEVICE
    cooperative DBS stimulation of STN and GPi sites
  • Closed-loop stimulation — DEVICE
    adaptive DBS stimulation of STN and/or GPi sites

Study Details

This study involves patients who are already planning to have deep brain stimulation (DBS) surgery to treat the symptoms of severe Parkinson's Disease (PD). The study has two goals: 1. to evaluate the effectiveness of implanting DBS electrodes in the two most common locations for DBS (subthalamic nucleus (STN), and globus pallidus interna (GPi)), instead of just one electrode, on each side of the brain; and 2. to develop an adaptive DBS system using brain signals measured from these two electrodes.

Key Dates

Start date
Jul 10, 2019
Status verified
Feb 2026
Primary completion
Jan 31, 2027
Completion
Jan 31, 2027

Study Design

Enrollment
46 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Implanted RC+S
    Implanted Medtronic RC+S IPG with dual DBS electrodes in STN and GPi. DBS stimulation will be administered to: 1) STN alone, 2) GPi alone, 3) cooperative STN + GPi, and 4) adaptive, closed-loop stimulation of STN and/or GPi.
  • No Intervention: speech rater
    blinded raters to score audio recordings of speech

Primary Outcome Measure

Change in Unified Parkinson's Disease Rating Scale (UPDRS) score: "on" medication, "on" stimulation at 12 months after IPG implant. [ Time Frame: baseline and 12 months after IPG implant ]

Locations (1)

FacilityCityStateZIPSite coordinators
Duke University Medical CenterDurhamNorth Carolina27710-

Find similar trials in Durham, NC

By condition
Parkinson's disease
By specialty
NeurologyBrain disorders
By research site
Duke University Medical Center· Durham, NC

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