Modulating Movement Intention Via Cortical Stimulation

Not Applicable

Recruiting

• Conditions: Seizure Disorder; Seizures; Psychogenic Movement Disorder

• 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.

Study Timeline

• Study Start: 2017-07-20
• Study First Submitted: 2017-07-24
• Study First Submitted QC: 2017-07-25
• Study First Posted: 2017-07-28
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-28
• Last Update Posted: 2025-01-29
• Primary Completion: 2027-05
• Study Completion: 2027-05

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

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Changes in signal intensity measured during EEG recording	3 Hours	as a result of altering cerebral perfusion in response to neurophysiologic stimulation
Changes in signal intensity measured during MEG	3 Hours	as a result of altering cerebral perfusion in response to neurophysiologic stimulation
Changes in signal intensity measured using of tDCS	30 Minutes	as a result of altering cerebral perfusion in response to neurophysiologic stimulation

Trial Locations

Locations (1)

New York University School of Medicine; 🇺🇸 New York, New York, United States