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Recruiting NCT03233399

Modulating Movement Intention Via Cortical Stimulation

No phase Interventional Seizures Seizure Disorder Psychogenic Movement Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Sham TMS3 stimulation, rTMS of left or right angular gyrus (AG) or frontal cortex (FC), Anodal tDCS of left or right AG or FC.
Who it may be relevant to
Registry conditions: Seizures, Seizure Disorder, Psychogenic Movement Disorder. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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.
  • 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.

Primary outcome measures

  • Changes in signal intensity measured using of tDCS [Time frame: 30 Minutes]
  • Changes in signal intensity measured during EEG recording [Time frame: 3 Hours]
  • Changes in signal intensity measured during MEG [Time frame: 3 Hours]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Basic science

Study locations

United States · 1 center
  • New York University School of Medicine — New York

Identifiers

NCT: NCT03233399 · 16-01859

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗