Cortical-Basal Ganglia Speech Networks

Parkinson Disease Clinical Trial

Official title:

Cortical-Basal Ganglia Speech Networks

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04286308
• Other study ID #: 2019P003841
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2020
• Est. completion date: February 2026

Study information

• Verified date: November 2023
• Source: Massachusetts General Hospital
• Contact: Mark Richardson, MD, PhD
• Phone: 412-877-4386
• Email: mark.richardson[@]mgh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: February 2026
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Dystonia
• Essential Tremor
• Parkinson Disease

Intervention

Other:
• electrophysiological data collection
Electrophysiological data collection at the time of DBS surgery.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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