Modulating Movement Intention Via Cortical Stimulation

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: Recruiting
• Conditions: Seizures; Seizure Disorder; Psychogenic Movement Disorder
• Intervention / Treatment: 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

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: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nalini Jeet; Phone Number: (212) 263-0228; Email: Nalini.Jeet@nyulangone.org

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • Recruiting
      • New York University School of Medicine
      • Contact: Steven Stork; Phone Number: 212-263-0001; Email: steven.stork@nyumc.org
      • Principal Investigator: Biyu He, MD

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Biyu He, MD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): July 20, 2017
• Primary Completion (Estimated): May 1, 2025
• Study Completion (Estimated): May 1, 2025

Study Registration Dates

• First Submitted: July 24, 2017
• First Submitted That Met QC Criteria: July 25, 2017
• First Posted (Actual): July 28, 2017

Study Record Updates

• Last Update Posted (Actual): March 27, 2024
• Last Update Submitted That Met QC Criteria: March 25, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Transcranial Magnetic Stimulation; Magnetoencephalography; Electroencephalography
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Epilepsy; Seizures; Movement Disorders
• Other Study ID 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