CClinicalTrials.gg
WithdrawnNCT04277689Updated Mar 27, 2026

Deep Neural Network Approaches for Closed-Loop Deep Brain Stimulation

An interventional study of Brain signal data collection in Parkinson Disease, sponsored by Massachusetts General Hospital. Withdrawn at 1 site in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-03-27.

Sponsored by Massachusetts General Hospital · Not applicable, Interventional, and Basic science

Why this study was withdrawn
protocol should not have been set up in the first place. no participants ever enrolled.
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Not applicable
Ages
18 Years to 85 Years
Sex
All
01

Study 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).

Read the 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.

02

Conditions studied

  • Parkinson Disease

Browse trials for

03

In context

Parkinson Disease

4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.

Browse Parkinson Disease studies →

Lead sponsor

Massachusetts General Hospital is the lead sponsor of 2,536 studies on the registry; 446 are open to participants now.

Of its 214 completed or terminated interventional studies of FDA-regulated products, 161 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
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

Exclusion Criteria:

1. Non-English-speaking subjects

05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Brain signal data collection

    Collection of brain data during deep brain stimulation

    Procedure: Brain signal data collection

Interventions

  • ProcedureBrain signal data collection

    Collection of speech related electrophysiological data at the time of DBS.

06

What researchers measure

Primary outcomes

  1. The number of subjects providing interpretable electrophysiological data during DBS surgery

    The number of subjects providing interpretable electrophysiological data during DBS surgery

    Time frame: Duration of single DBS surgery

07

Study locations

1 site
  • Massachusetts General Hospital
    Boston, Massachusetts 02114, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04277689
Lead sponsor
Massachusetts General Hospital
Responsible party
Robert Mark Richardson (Director of Functional Neurosurgery at MGH, Massachusetts General Hospital) — Principal investigator
First posted
Feb 20, 2020
Start date
Jun 10, 2021
Primary completion
Feb 17, 2025
Completion
Feb 27, 2026
Last update
Mar 27, 2026

Study contacts

Robert M Richardson, MD, PhD
principal investigator · Massachusetts General Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion