NCT02731365

Concurrent DBS Local Field Potential Analysis and Stimulation in a Closed-Loop Neuromodulation Device

Concurrent Deep Brain Stimulation (DBS) Local Field Potential Analysis and Stimulation in a Closed-Loop Neuromodulation Device

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Vibhor Krishna · Academic / Other
• Sex: All
• Age: 22 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this clinical study is to allow the investigation of local field potential (LFP) signals in patients treated with DBS of the STN. This study will identify common LFP biomarkers observed as a function of disease symptoms, medication effect, fluctuations in disease, and changes resulting from adjustments from current standard practices of DBS programming. The data collected and LFP markers identified will serve as guidelines for future stimulation predicted programming.

Detailed description

The goals of this study are to evaluate local field potentials (LFP) and associated beta, gamma and other band oscillations and their correlation with disease pathophysiology and clinical status of the patients, and to potentially determine a more objective biomarker of response to deep brain stimulation (DBS) treatment. This study aims to find evidence that changes in the power and coherence of the beta and gamma bands can be consistently linked to DBS adjustment and associated clinical effects. This approach can be of significant potential benefit to provide a foundation for closed loop DBS therapy in patients with continuous DBS adjustments. This study will use a novel bi-directional neural interface system that can chronically and simultaneously record, sense, process and telemeter LFP signals from DBS electrode (Rouse et al. 2011) to study the stability and subsequent change to LFP linked to the clinical state relevant to the present disorder, and DBS stimulation at rest and during motor and cognitive tasks. This investigation will be conducted at the Ohio State University.

Conditions

• Parkinson's Disease

Interventions

Type	Name	Description
DEVICE	Activa PC+S	The Activa PC+S is a newly developed Medtronic DBS implantable system and is available for use in clinical research. This system has a mechanism for both sensing of LFP and the ability to provide deep brain stimulation therapy. The sensing capabilities are controllable with data management using a clinician sensing tablet programmer that has a USB extension allowing for telemetry to an encrypted, locked computer.

Timeline

• Start date: 2015-02-01
• Primary completion: 2016-11-01
• Completion: 2016-11-01
• First posted: 2016-04-07
• Last updated: 2016-11-17

Locations

1 site across 1 country: United States