Modulating Movement Intention Via Cortical Stimulation

NCT03233399 | Recruiting FDA Device

• 1 other identifier: 16-01859
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Seizures; Seizure Disorder; Psychogenic Movement Disorder

Keywords

Electroencephalography; Magnetoencephalography; Transcranial Magnetic Stimulation

Outcome Measures

Primary Outcomes (3)

• Changes in signal intensity measured using of tDCS

  as a result of altering cerebral perfusion in response to neurophysiologic stimulation

  30 Minutes

• Changes in signal intensity measured during EEG recording

  as a result of altering cerebral perfusion in response to neurophysiologic stimulation

  3 Hours

• Changes in signal intensity measured during MEG

  as a result of altering cerebral perfusion in response to neurophysiologic stimulation

  3 Hours

Study Arms (2)

Healthy Patients

ACTIVE COMPARATOR

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

Device: Sham TMS3 stimulation; Device: rTMS of left or right angular gyrus (AG) or frontal cortex (FC); Device: Anodal tDCS of left or right AG or FC

PMD/PNES patients

ACTIVE COMPARATOR

PMD and PNES subjects will be referred by the treating

Device: Sham TMS3 stimulation; Device: rTMS of left or right angular gyrus (AG) or frontal cortex (FC); Device: Anodal tDCS of left or right AG or FC

Interventions

Sham TMS3 stimulation DEVICE

half of the subjects will receive sham stimulation first

Healthy Patients; PMD/PNES patients

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

Also known as: 45 Minutes

Healthy Patients; PMD/PNES patients

Anodal tDCS of left or right AG or FC 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.

Also known as: 30 Minutes

Healthy Patients; PMD/PNES patients

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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

You may not qualify if:

• 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);

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

RECRUITING

MeSH Terms

Conditions

Seizures; Epilepsy

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Brain Diseases; Central Nervous System Diseases

Study Officials

• Biyu He, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nalini Jeet

CONTACT

(212) 263-0228; Nalini.Jeet@nyulangone.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2017
• First Posted: July 28, 2017
• Study Start: July 20, 2017
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: November 28, 2025

Record last verified: 2025-11

Locations

US (1)