Clinical trial NCT03233399: 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
Overall status: RECRUITING
Phase: NA
Conditions: Seizures
Seizure Disorder
Psychogenic Movement Disorder
Keywords: Electroencephalography
Magnetoencephalography
Transcranial Magnetic Stimulation
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2017-07-28
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: Changes in signal intensity measured using of tDCS
timeFrame: 30 Minutes
measure: Changes in signal intensity measured during EEG recording
timeFrame: 3 Hours
measure: Changes in signal intensity measured during MEG
timeFrame: 3 Hours
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: NYU Langone Health
name: Biyu He, MD
role: PRINCIPAL_INVESTIGATOR
References: