TrialReader


Modulating Movement Intention Via Cortical Stimulation

NCT03233399 — Not applicable, Recruiting, 30 participants, NYU Langone Health

ClinicalTrials Daily  ·  Areas  ·  Conditions  ·  Drugs  ·  Sponsors  ·  

Modulating Movement Intention Via Cortical Stimulation in Healthy Subjects and Patients With Psychogenic Movement Disorders and Non-epileptic Seizures

RegistryNCT03233399
StatusRecruiting
PhaseNot applicable
Study typeInterventional; non randomized, parallel, masking: none, basic science
Enrollment30 (Estimated)
SponsorNYU Langone Health (Other)
ConditionsSeizures, Seizure Disorder, Psychogenic Movement Disorder
InterventionsSham TMS3 stimulation, rTMS of left or right angular gyrus (AG) or frontal cortex (FC), Anodal tDCS of left or right AG or FC (Device)
Datesstart 2017-07-20, primary completion 2027-05-01 (estimated), completion 2027-05-01 (estimated), first posted 2017-07-28, last updated 2026-09-25
Locations1 site in United States

Related Papers Related Patents Related Grants Related Experts
AI Assistant Save
All trials for Seizures All trials for Seizure Disorder All trials of Sham TMS3 stimulation All trials of rTMS of left or right angular gyrus (AG) or frontal cortex (FC)

-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.

Expand all sections  ·  Collapse all

+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.

+Arms and interventions

ArmTypeInterventionsDescription
Healthy PatientsActive comparatorDevice: 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 FCAll healthy volunteers will complete the healthy volunteer form, MRI safety screening form, and the Montreal Cognitive Assessment (MOCA).
PMD/PNES patientsActive comparatorDevice: 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 FCPMD and PNES subjects will be referred by the treating
  • Sham TMS3 stimulation (Device): half of the subjects will receive sham stimulation first
  • rTMS of left or right angular gyrus (AG) or frontal cortex (FC) (Device), also known as 45 Minutes: 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 (Device), also known as 30 Minutes: 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.

+Outcome measures

Primary outcomes

  • Changes in signal intensity measured using of tDCS [30 Minutes]: as a result of altering cerebral perfusion in response to neurophysiologic stimulation
  • Changes in signal intensity measured during EEG recording [3 Hours]: as a result of altering cerebral perfusion in response to neurophysiologic stimulation
  • Changes in signal intensity measured during MEG [3 Hours]: as a result of altering cerebral perfusion in response to neurophysiologic stimulation

+Eligibility

Sex: All, ages: 18 Years to 65 Years, accepts 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

+Locations (1)

FacilityCityCountryStatus
New York University School of MedicineNew York, New YorkUnited StatesRecruiting

+Investigators

  • Biyu He, MD, Principal investigator, NYU Langone Health

My Notes