Biomarkers to Guide Directional DBS for Parkinson's Disease

Noninvasive Biomarkers to Advance Emerging DBS Electrode Technologies in Parkinson's Disease

Recruitment Information:

Seeking volunteers with following diagnosis: PD, Control Volunteers Accepted Study Type: Interventional
Eligible Ages: 18 - 70 Status: Recruiting
Time Since Diagnosis: Any may be eligible Study Focus:

Study Purpose:

The purpose of this study is to investigate the clinical efficacy of directional DBS electrode technology and whether electrophysiology biomarkers can predict effective contact segments for chronic therapy.

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More Details

Although deep brain stimulation (DBS) can be remarkable for treating symptoms of Parkinson's disease, improvement varies across clinical trials, individual patients, and over time. A major limitation to the advancement of DBS therapy is that there are no established biomarkers to tailor stimulator settings in individuals. Emerging segmented ("directional") lead technology allows current steering, a new opportunity to improve tolerability and efficacy by shaping the DBS electrical field. This novel lead design has 8 contacts rather than the 4 available with currently available leads. How do we optimally adjust stimulation parameters when there are far more potentially useful settings than can be practically evaluated in clinic? How do we know that DBS settings in a given patient are optimal or appropriate? We have pioneered minimally invasive, rapidly acquired biomarkers to solve these important problems. Using electrocorticography, electroencephalography, and subcortical local field potentials, we will measure whether resting or stimulus-evoked electrophysiology can serve as a predictive biomarker to guide activation and adjustment of a directional DBS system. The purpose of this randomized, double-blind crossover study is to measure the clinical efficacy of directional versus omnidirectional stimulation and to explore whether electrophysiology biomarkers can rapidly predict effective, well-tolerated contacts for directional DBS therapy.

Phase: N/A Lead Sponsor: University of Alabama at Birmingham
Trial ID: 005122 Sponsor Type: Other
Primary Country: United States Additional Collaborators or Sponsors: National Institutes of Health (NIH), National Institute of Neurological Disorders and Stroke (NINDS)
Estimated Enrollment: 40 Study Start Date: November 2017
Estimated Study Completion Date: December 2022 Source: ClinicalTrials.gov
Study Website:

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