Modulating Movement Intention Via Cortical Stimulation

NCT ID: NCT03233399

Last Updated: 2025-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-20

Study Completion Date

2027-05-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Seizures Seizure Disorder Psychogenic Movement Disorder

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Healthy Patients

All healthy volunteers will complete the healthy volunteer form, MRI safety screening form, and the Montreal Cognitive Assessment (MOCA).

Group Type ACTIVE_COMPARATOR

Sham TMS3 stimulation

Intervention Type DEVICE

half of the subjects will receive sham stimulation first

rTMS of left or right angular gyrus (AG) or frontal cortex (FC)

Intervention Type DEVICE

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.

Anodal tDCS of left or right AG or FC

Intervention Type DEVICE

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.

PMD/PNES patients

PMD and PNES subjects will be referred by the treating

Group Type ACTIVE_COMPARATOR

Sham TMS3 stimulation

Intervention Type DEVICE

half of the subjects will receive sham stimulation first

rTMS of left or right angular gyrus (AG) or frontal cortex (FC)

Intervention Type DEVICE

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.

Anodal tDCS of left or right AG or FC

Intervention Type DEVICE

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.

Interventions

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Sham TMS3 stimulation

half of the subjects will receive sham stimulation first

Intervention Type 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.

Intervention Type 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.

Intervention Type DEVICE

Other Intervention Names

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45 Minutes 30 Minutes

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Biyu He, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

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New York University School of Medicine

New York, New York, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Nalini Jeet

Role: CONTACT

(212) 263-0228

Facility Contacts

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Steven Stork

Role: primary

212-263-0001

Other Identifiers

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16-01859

Identifier Type: -

Identifier Source: org_study_id

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