Cortical-Basal Ganglia Speech Networks | NCT04286308

Studies
Cortical-Basal Ganglia Speech Networks

NCT04286308

Sponsor

Massachusetts General Hospital

Status

Recruiting

Last Update Posted

Mar 25, 2026Actual

Enrollment

80Estimated

Phase

Not Applicable

Conditions

Parkinson Disease
Essential Tremor
Dystonia

Interventions

electrophysiological data collection

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2020Actual

Primary Completion Date

Feb 2027Estimated

Completion Date

Feb 2027Estimated

First Submitted Date

Jan 8, 2020

First Submission Date that Met QC Criteria

Feb 25, 2020

First Posted Date

Feb 27, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 23, 2026

Last Update Posted Date

Mar 25, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Robert Mark Richardson, Director of Functional Neurosurgery, Massachusetts General HospitalPrincipal Investigator

Lead Sponsor

Massachusetts General HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

In this research study the researchers want to learn more about brain activity related to speech perception and production.

Detailed Description

Speech production is disrupted in a number of neurological diseases that involve the basal ganglia, including Parkinson's disease (PD) and dystonia. The investigators will use a novel experimental approach and combination of analytic techniques to elucidate the contribution of neural activity in cortical-basal ganglia circuits to the hierarchical control of speech production, in subjects undergoing deep brain stimulation surgery.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Brain signal data collection	Experimental	Brain signal data collection at the time of deep brain stimulation (DBS) surgery.	Other: electrophysiological data collection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
electrophysiological data collection	Other	Electrophysiological data collection at the time of DBS surgery.	Brain signal data collection

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The number of subjects providing the interpretable speech related electrophysiological data collection.	The number of subjects providing the interpretable speech related electrophysiological data during DBS surgery.	Duration of single DBS surgery

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Subjects with reported hearing loss.
Non-English-speaking subjects

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mark Richardson, MD, PhD	Contact	617-726-8849		mark.richardson@mgh.harvard.edu
Erin Donahue, PhD	Contact			ekdonahue@mgh.harvard.edu

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Massachusetts General Hospital	Recruiting	Boston	Massachusetts	02114	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010300	Parkinson Disease
D020329	Essential Tremor
D004421	Dystonia

Ancestor Terms

ID	Term
D020734	Parkinsonian Disorders
D001480	Basal Ganglia Diseases
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided