MedPath

Modulating Movement Intention Via Cortical Stimulation

Not Applicable
Recruiting
Conditions
Seizure Disorder
Seizures
Psychogenic Movement Disorder
Interventions
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
Registration Number
NCT03233399
Lead Sponsor
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.

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.

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
30
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
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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
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
PMD/PNES patientsSham TMS3 stimulationPMD and PNES subjects will be referred by the treating
PMD/PNES patientsAnodal tDCS of left or right AG or FCPMD and PNES subjects will be referred by the treating
Healthy PatientsrTMS of left or right angular gyrus (AG) or frontal cortex (FC)All healthy volunteers will complete the healthy volunteer form, MRI safety screening form, and the Montreal Cognitive Assessment (MOCA).
PMD/PNES patientsrTMS of left or right angular gyrus (AG) or frontal cortex (FC)PMD and PNES subjects will be referred by the treating
Healthy PatientsSham TMS3 stimulationAll healthy volunteers will complete the healthy volunteer form, MRI safety screening form, and the Montreal Cognitive Assessment (MOCA).
Healthy PatientsAnodal 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).
Primary Outcome Measures
NameTimeMethod
Changes in signal intensity measured during EEG recording3 Hours

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

Changes in signal intensity measured during MEG3 Hours

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

Changes in signal intensity measured using of tDCS30 Minutes

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

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

New York University School of Medicine

🇺🇸

New York, New York, United States

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