NCT04286308

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P75+ for not_applicable parkinson-disease

Timeline
9mo left

Started Oct 2020

Longer than P75 for not_applicable parkinson-disease

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress88%
Oct 2020Feb 2027

First Submitted

Initial submission to the registry

January 8, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 27, 2020

Completed
7 months until next milestone

Study Start

First participant enrolled

October 1, 2020

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2027

Last Updated

March 25, 2026

Status Verified

January 1, 2026

Enrollment Period

6.3 years

First QC Date

January 8, 2020

Last Update Submit

March 23, 2026

Conditions

Parkinson DiseaseEssential TremorDystonia

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Brain signal data collection

EXPERIMENTAL

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

Other: electrophysiological data collection

Interventions

electrophysiological data collectionOTHER

Electrophysiological data collection at the time of DBS surgery.

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, essential tremor or dystonia.
  • Subjects able to provide informed consent and comply with task instructions.
  • Subjects 18-85 years old

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

MeSH Terms

Conditions

Parkinson DiseaseEssential TremorDystonia

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesDyskinesiasNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Mark Richardson, MD, PhD

CONTACT

617-726-8849mark.richardson@mgh.harvard.edu

Erin Donahue, PhD

CONTACT

ekdonahue@mgh.harvard.edu

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

Study Record Dates

First Submitted

January 8, 2020

First Posted

February 27, 2020

Study Start

October 1, 2020

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 1, 2027

Last Updated

March 25, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)