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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03233399
Other study ID # 16-01859
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date July 20, 2017
Est. completion date May 2025

Study information

Verified date March 2024
Source NYU Langone Health
Contact Nalini Jeet
Phone (212) 263-0228
Email Nalini.Jeet@nyulangone.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 information / eligibility

Status Recruiting
Enrollment 30
Est. completion date May 2025
Est. primary completion date May 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Study Design


Intervention

Device:
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.

Locations

Country Name City State
United States New York University School of Medicine New York New York

Sponsors (1)

Lead Sponsor Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in signal intensity measured using of tDCS as a result of altering cerebral perfusion in response to neurophysiologic stimulation 30 Minutes
Primary Changes in signal intensity measured during EEG recording as a result of altering cerebral perfusion in response to neurophysiologic stimulation 3 Hours
Primary Changes in signal intensity measured during MEG as a result of altering cerebral perfusion in response to neurophysiologic stimulation 3 Hours
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