Modulating Movement Intention Via Cortical Stimulation

November 25, 2025 updated by: NYU Langone Health

Modulating Movement Intention Via Cortical Stimulation in Healthy Subjects and Patients With Psychogenic Movement Disorders and Non-epileptic Seizures

The purpose of this protocol is to learn about movement intention and volition. To improve such knowledge, investigators will conduct sub-studies using multiple non-invasive methodologies. These results could provide preliminary data for subsequent studies evaluating local and global efficacy of plasticity-inducing treatments for PMD symptoms.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study will:

  • Explore effects of TMS and tDCS on movement intention.
  • Discern the neural activity underlying modulation of movement intention with neuroimaging recording.
  • Identify brain stimulation's effect in patients with psychogenic tremor and non-epileptic seizures.
  • Technical development of new experimental paradigms and data analysis methods.
  • Data collection for hypotheses development.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10016
        • Recruiting
        • New York University School of Medicine
        • Contact:
        • Principal Investigator:
          • Biyu He, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

(Healthy Controls)

  • Fluent in English

(Patients with PMD or PNES):

  • Diagnosis of PMD/PNES confirmed by a neurologist with expertise in movement disorders.
  • Per the treating neurologist, subject is unlikely to require treatment and/or dosage changes for 3-6 months following screening

Exclusion Criteria:

  • Any history of a significant neurological disorder, which may interfere with the interpretation of study data, as determined by the PI
  • Chronic or progressive medical condition
  • Any history of traumatic brain injury or significant head trauma
  • Currently meets criteria for substance abuse or dependence
  • History of any psychotic disorder or other psychiatric condition which may interfere with data interpretation
  • Pregnancy
  • Metal or devices in the head, including neurostimulators or metal foreign bodies
  • Any other implanted metal device, including pacemaker, spinal cord stimulator, VNS.
  • Any other ferromagnetic substance in the body that may increase study risk (including dental prosthetics, etc.).
  • Taking tricyclic antidepressant or antiepileptic medications or CNS active drugs under "strong potential hazard" list in Rossi et al., 2009
  • Current diagnosis of any inflammatory or autoimmune disorder within last 6 months

PMD and PNES Patients

  • Any history of traumatic brain injury or significant head trauma
  • Diagnosis of organic seizure disorder, including febrile seizures and tonic-clonic seizures;
  • Neurological disorder other than PMD and PNES including stroke, fainting spells or syncope of unknown cause(s);
  • Major or unstable medical illness, especially any current diagnosis of inflammatory or autoimmune disorders within last 6 months
  • Metal or devices in the head, including neurostimulators or metal foreign bodies
  • Taking tricyclic antidepressant medications or CNS active drugs under "strong potential hazard" list in Rossi et al., 2009;
  • Diagnosis of dementia, or Montreal Cognitive Assessment (MoCA) ≤24;
  • Recurrent visual hallucinations, within the past 6 months;
  • History of significant uncontrollable movements of the head;
  • Any clinically significant abnormality on vital signs

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Healthy Patients
All healthy volunteers will complete the healthy volunteer form, MRI safety screening form, and the Montreal Cognitive Assessment (MOCA).
Device: Sham TMS3 stimulation
half of the subjects will receive sham stimulation first
Device: rTMS of left or right angular gyrus (AG) or frontal cortex (FC)
Half of the subjects will receive active stimulation first; A subject may receive either TMS or tDCS stimulation, but not both, over the course of the sub-study.
Other Names:
  • 45 Minutes
Device: Anodal tDCS of left or right AG or FC
Half of the subjects will receive active stimulation first; A subject may receive either TMS or tDCS stimulation, but not both, over the course of the sub-study.
Other Names:
  • 30 Minutes
Active Comparator: PMD/PNES patients
PMD and PNES subjects will be referred by the treating
Device: Sham TMS3 stimulation
half of the subjects will receive sham stimulation first
Device: rTMS of left or right angular gyrus (AG) or frontal cortex (FC)
Half of the subjects will receive active stimulation first; A subject may receive either TMS or tDCS stimulation, but not both, over the course of the sub-study.
Other Names:
  • 45 Minutes
Device: Anodal tDCS of left or right AG or FC
Half of the subjects will receive active stimulation first; A subject may receive either TMS or tDCS stimulation, but not both, over the course of the sub-study.
Other Names:
  • 30 Minutes

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Changes in signal intensity measured using of tDCS
Time Frame: 30 Minutes
as a result of altering cerebral perfusion in response to neurophysiologic stimulation
30 Minutes
Changes in signal intensity measured during EEG recording
Time Frame: 3 Hours
as a result of altering cerebral perfusion in response to neurophysiologic stimulation
3 Hours
Changes in signal intensity measured during MEG
Time Frame: 3 Hours
as a result of altering cerebral perfusion in response to neurophysiologic stimulation
3 Hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
NYU Langone Health

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Biyu He, MD, NYU Langone Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 20, 2017

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 24, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 25, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 28, 2017

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 28, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 25, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 16-01859

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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