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Deep Neural Network Approaches for Closed-Loop Deep Brain Stimulation

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Mass General Brigham

Status

Invitation-only

Conditions

Parkinson Disease

Treatments

Procedure: Brain signal data collection

Study type

Interventional

Funder types

Other

Identifiers

NCT04277689
2019P003874

Details and patient eligibility

About

In this research study the researchers want to learn more about brain activity related to speech perception and production in patients with Parkinson's Disease who are undergoing deep brain stimulation (DBS).

Full description

Deep brain stimulation (DBS) is the gold-standard treatment for patients with medication resistant motor complications of Parkinson's disease (PD) and provides the only opportunity to record and stimulate in the human basal ganglia. Most recently, the concurrent use of research electrocorticography (ECoG) during DBS surgery, including pioneering work from Pittsburgh, has further enabled basic neuroscience investigation of human cortical-subcortical network dynamics. The discovery that aberrant synchronization of rhythmic neuronal activity recorded in PD patients is suppressed by DBS has advanced the concept that measures associated with pathological activity may be used as biomarkers to control the delivery of DBS therapy. Pilot studies of aDBS in PD have reported promising clinical results from triggering DBS stimulation when the signal recorded from the DBS electrode showed a high level of oscillatory power in the beta frequency range (13 - 35 Hz). That approach, however, has important limitations. Most importantly, beta power recorded from the DBS lead is suppressed by movement including PD tremor, its detection is highly dependent on lead location and the recording montage needed to record during stimulation is incompatible with directional current steering, a recent innovation employing segmented stimulation contacts. The inherent complexity of the increased parameter space through DBS innovations also overwhelms standard programming techniques. Finally, use of additional biomarker signals (e.g., recorded from cortex) is likely to improve the ability to adaptively control DBS for disorders marked by complex multidimensional symptomatologies such as PD. The current proposal will establish methods for overcoming these limitations by developing techniques for multi-feature classification from ECoG recordings, using advanced machine learning algorithms.

Enrollment

30 estimated patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. Subjects scheduled for DBS implantation, as determined by the clinical multidisciplinary movement disorders board with definitive diagnosis of Parkinson's disease
  2. Subjects able to provide informed consent and comply with task instructions.
  3. Subjects 18-85 years old

Exclusion criteria

1. Non-English-speaking subjects

Trial design

Primary purpose

Basic Science

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

30 participants in 1 patient group

Brain signal data collection
Experimental group
Description:
Collection of brain data during deep brain stimulation
Treatment:
Procedure: Brain signal data collection

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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