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Cortical-Basal Ganglia Speech Networks

Primary Purpose

Parkinson Disease, Essential Tremor, Dystonia

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
electrophysiological data collection
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Parkinson Disease

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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, essential tremor or dystonia.
  2. Subjects able to provide informed consent and comply with task instructions.
  3. Subjects 18-85 years old

Exclusion Criteria:

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

Sites / Locations

  • Massachusetts General HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Brain signal data collection

Arm Description

Brain signal data collection at the time of deep brain stimulation (DBS) surgery.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
January 8, 2020
Last Updated
November 11, 2022
Sponsor
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04286308
Brief Title
Cortical-Basal Ganglia Speech Networks
Official Title
Cortical-Basal Ganglia Speech Networks
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2020 (Actual)
Primary Completion Date
February 2025 (Anticipated)
Study Completion Date
February 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease, Essential Tremor, Dystonia

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Brain signal data collection
Arm Type
Experimental
Arm Description
Brain signal data collection at the time of deep brain stimulation (DBS) surgery.
Intervention Type
Other
Intervention Name(s)
electrophysiological data collection
Intervention Description
Electrophysiological data collection at the time of DBS surgery.
Primary Outcome Measure Information:
Title
The number of subjects providing the interpretable speech related electrophysiological data collection.
Description
The number of subjects providing the interpretable speech related electrophysiological data during DBS surgery.
Time Frame
Duration of single DBS surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mark Richardson, MD, PhD
Phone
412-877-4386
Email
mark.richardson@mgh.harvard.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Caroline Neely, PhD
Email
cneely@mgh.harvard.edu
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert M Richardson, MD PhD
Phone
412-877-4386
Email
mark.richardson@mgh.harvard.edu
First Name & Middle Initial & Last Name & Degree
Caroline Neely, PhD
Email
cneely@mgh.harvard.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Cortical-Basal Ganglia Speech Networks

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