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Modulating Movement Intention Via Cortical Stimulation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03233399
Recruitment Status : Recruiting
First Posted : July 28, 2017
Last Update Posted : September 13, 2019
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

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.

Condition or disease Intervention/treatment Phase
Seizures Seizure Disorder Psychogenic Movement Disorder 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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Modulating Movement Intention Via Cortical Stimulation in Healthy Subjects and Patients With Psychogenic Movement Disorders and Non-epileptic Seizures
Actual Study Start Date : July 20, 2017
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine


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 Name: 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 Name: 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 Name: 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 Name: 30 Minutes




Primary Outcome Measures :
  1. Changes in signal intensity measured using of tDCS [ Time Frame: 30 Minutes ]
    as a result of altering cerebral perfusion in response to neurophysiologic stimulation

  2. 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. Changes in signal intensity measured during MEG [ Time Frame: 3 Hours ]
    as a result of altering cerebral perfusion in response to neurophysiologic stimulation



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03233399


Contacts
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Contact: Steven Stork 212 263 0001 steven.stork@nyumc.org

Locations
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United States, New York
New York University School of Medicine Recruiting
New York, New York, United States, 10016
Contact: Steven Stork    212-263-0001    steven.stork@nyumc.org   
Principal Investigator: Biyu He, MD         
Sponsors and Collaborators
NYU Langone Health
Investigators
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Principal Investigator: Biyu He, MD NYU Langone Health

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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT03233399    
Other Study ID Numbers: 16-01859
First Posted: July 28, 2017    Key Record Dates
Last Update Posted: September 13, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by NYU Langone Health:
Electroencephalography
Magnetoencephalography
Transcranial Magnetic Stimulation
Additional relevant MeSH terms:
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Seizures
Movement Disorders
Epilepsy
Disease
Pathologic Processes
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Central Nervous System Diseases
Brain Diseases