Parkinson DiseaseNCT04286308
Cortical-Basal Ganglia Speech Networks
A study testing electrophysiological data collection in people with Parkinson Disease and Essential Tremor, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
In this research study the researchers want to learn more about brain activity related to speech perception and production. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Parkinson Disease, Essential Tremor, Dystonia
- What is being tested?
- electrophysiological data collection
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2020to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Subjects with reported hearing loss.
- Non-English-speaking subjects
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Erin Donahue, PhD contact
United States1 site, 1 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Robert M Richardson, MD PhD, 617-726-8849, mark.richardson@mgh.harvard.edu
Erin Donahue, PhD, ekdonahue@mgh.harvard.edu
About this study
In this research study the researchers want to learn more about brain activity related to speech perception and production.
Read the 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.
- Conditions
- Parkinson Disease, Essential Tremor, Dystonia
- Being tested
- electrophysiological data collection
- Medical subject headings
- Parkinson Disease, Essential Tremor, Dystonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electrophysiological data collectionOther
Electrophysiological data collection at the time of DBS surgery.
| Study group | Role | What they receive |
|---|---|---|
| Brain signal data collection | Experimental | Brain signal data collection at the time of deep brain stimulation (DBS) surgery. Receives: Other: electrophysiological data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Duration of single DBS surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2020
- Study start1 Oct 2020
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert Mark Richardson, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04286308
- Sponsor's protocol ID
- 2019P003841
- Status last verified
- Jan 2026
- First submitted
- 8 Jan 2020
- Last updated
- 25 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cortical-Basal Ganglia Speech Networks
- ClinicalTrials.gov ID
- NCT04286308
- Acronym / sponsor ID
- 2019P003841
- Conditions
- Parkinson Disease, Essential Tremor, Dystonia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 27 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Brain signal data collection | Experimental | Other: electrophysiological data collectionBrain signal data collection at the time of deep brain stimulation (DBS) surgery. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Subjects with reported hearing loss.
- Non-English-speaking subjects
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| electrophysiological data collectionElectrophysiological data collection at the time of DBS surgery. | Other | Brain signal data collection |
Primary outcome
The number of subjects providing the interpretable speech related electrophysiological data collection.
Time frame: Duration of single DBS surgery
The number of subjects providing the interpretable speech related electrophysiological data during DBS surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Erin Donahue, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing electrophysiological data collection in people with Parkinson Disease and Essential Tremor, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mark Richardson, MD, PhD (617-726-8849, mark.richardson@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of subjects providing the interpretable speech related electrophysiological data collection. (time frame: Duration of single DBS surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2026.