NCT04277689

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).

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2021

Longer than P75 for not_applicable parkinson-disease

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 8, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 20, 2020

Completed
1.3 years until next milestone

Study Start

First participant enrolled

June 10, 2021

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 17, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 27, 2026

Completed
Last Updated

March 27, 2026

Status Verified

January 1, 2026

Enrollment Period

3.7 years

First QC Date

January 8, 2020

Last Update Submit

March 23, 2026

Conditions

Parkinson Disease

Outcome Measures

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

    Duration of single DBS surgery

Study Arms (1)

Brain signal data collection

EXPERIMENTAL

Collection of brain data during deep brain stimulation

Procedure: Brain signal data collection

Interventions

Brain signal data collectionPROCEDURE

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

Brain signal data collection

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • \. Non-English-speaking subjects

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Robert M Richardson, MD, PhD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Functional Neurosurgery at MGH

Study Record Dates

First Submitted

January 8, 2020

First Posted

February 20, 2020

Study Start

June 10, 2021

Primary Completion

February 17, 2025

Study Completion

February 27, 2026

Last Updated

March 27, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)