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Modulating Movement Intention Via Cortical Stimulation

Primary Purpose

Seizures, Seizure Disorder, Psychogenic Movement Disorder

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sham TMS3 stimulation
rTMS of left or right angular gyrus (AG) or frontal cortex (FC)
Anodal tDCS of left or right AG or FC
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Seizures focused on measuring Electroencephalography, Magnetoencephalography, Transcranial Magnetic Stimulation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • New York University School of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Healthy Patients

PMD/PNES patients

Arm Description

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

PMD and PNES subjects will be referred by the treating

Outcomes

Primary Outcome Measures

Changes in signal intensity measured using of tDCS
as a result of altering cerebral perfusion in response to neurophysiologic stimulation
Changes in signal intensity measured during EEG recording
as a result of altering cerebral perfusion in response to neurophysiologic stimulation
Changes in signal intensity measured during MEG
as a result of altering cerebral perfusion in response to neurophysiologic stimulation

Secondary Outcome Measures

Full Information

First Posted
July 24, 2017
Last Updated
May 3, 2023
Sponsor
NYU Langone Health
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1. Study Identification

Unique Protocol Identification Number
NCT03233399
Brief Title
Modulating Movement Intention Via Cortical Stimulation
Official Title
Modulating Movement Intention Via Cortical Stimulation in Healthy Subjects and Patients With Psychogenic Movement Disorders and Non-epileptic Seizures
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 20, 2017 (Actual)
Primary Completion Date
May 2025 (Anticipated)
Study Completion Date
May 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Seizures, Seizure Disorder, Psychogenic Movement Disorder
Keywords
Electroencephalography, Magnetoencephalography, Transcranial Magnetic Stimulation

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Healthy Patients
Arm Type
Active Comparator
Arm Description
All healthy volunteers will complete the healthy volunteer form, MRI safety screening form, and the Montreal Cognitive Assessment (MOCA).
Arm Title
PMD/PNES patients
Arm Type
Active Comparator
Arm Description
PMD and PNES subjects will be referred by the treating
Intervention Type
Device
Intervention Name(s)
Sham TMS3 stimulation
Intervention Description
half of the subjects will receive sham stimulation first
Intervention Type
Device
Intervention Name(s)
rTMS of left or right angular gyrus (AG) or frontal cortex (FC)
Other Intervention Name(s)
45 Minutes
Intervention Description
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
Intervention Name(s)
Anodal tDCS of left or right AG or FC
Other Intervention Name(s)
30 Minutes
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in signal intensity measured using of tDCS
Description
as a result of altering cerebral perfusion in response to neurophysiologic stimulation
Time Frame
30 Minutes
Title
Changes in signal intensity measured during EEG recording
Description
as a result of altering cerebral perfusion in response to neurophysiologic stimulation
Time Frame
3 Hours
Title
Changes in signal intensity measured during MEG
Description
as a result of altering cerebral perfusion in response to neurophysiologic stimulation
Time Frame
3 Hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nalini Jeet
Phone
(212) 263-0228
Email
Nalini.Jeet@nyulangone.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Biyu He, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Steven Stork
Phone
212-263-0001
Email
steven.stork@nyumc.org
First Name & Middle Initial & Last Name & Degree
Biyu He, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Modulating Movement Intention Via Cortical Stimulation

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