Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
30 participants
INTERVENTIONAL
2017-07-20
2027-05-31
Brief Summary
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Detailed Description
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* 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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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Healthy Patients
All healthy volunteers will complete the healthy volunteer form, MRI safety screening form, and the Montreal Cognitive Assessment (MOCA).
Sham TMS3 stimulation
half of the subjects will receive sham stimulation first
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.
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.
PMD/PNES patients
PMD and PNES subjects will be referred by the treating
Sham TMS3 stimulation
half of the subjects will receive sham stimulation first
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.
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.
Interventions
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Sham TMS3 stimulation
half of the subjects will receive sham stimulation first
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.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
Yes
Sponsors
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NYU Langone Health
OTHER
Responsible Party
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Principal Investigators
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Biyu He, MD
Role: PRINCIPAL_INVESTIGATOR
NYU Langone Health
Locations
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New York University School of Medicine
New York, New York, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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16-01859
Identifier Type: -
Identifier Source: org_study_id
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