Deep Neural Network Approaches for Closed-Loop Deep Brain Stimulation

Sponsor
Massachusetts General Hospital (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT04277689
Collaborator
(none)
30
1
1
55.8
0.5

Study Details

Study Description

Brief Summary

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).

Condition or Disease Intervention/Treatment Phase
  • Procedure: Brain signal data collection
N/A

Detailed 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Deep Neural Network Approaches for Closed-Loop Deep Brain Stimulation
Actual Study Start Date :
Jun 10, 2021
Anticipated Primary Completion Date :
Feb 1, 2025
Anticipated Study Completion Date :
Feb 1, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: Brain signal data collection

Collection of brain data during deep brain stimulation

Procedure: Brain signal data collection
Collection of speech related electrophysiological data at the time of DBS.

Outcome Measures

Primary Outcome Measures

  1. The number of subjects providing interpretable electrophysiological data during DBS surgery [Duration of single DBS surgery]

    The number of subjects providing interpretable electrophysiological data during DBS surgery

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Massachusetts General Hospital Boston Massachusetts United States 02114

Sponsors and Collaborators

  • Massachusetts General Hospital

Investigators

  • Principal Investigator: Robert M Richardson, MD, PhD, Massachusetts General Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Robert Mark Richardson, Director of Functional Neurosurgery at MGH, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT04277689
Other Study ID Numbers:
  • 2019P003874
First Posted:
Feb 20, 2020
Last Update Posted:
Aug 9, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 9, 2022