Modulating Movement Intention Via Cortical Stimulation in Healthy Subjects and Patients With Psychogenic Movement Disorders and Non-epileptic Seizures
| Registry | NCT03233399 |
|---|---|
| Status | Recruiting |
| Phase | Not applicable |
| Study type | Interventional; non randomized, parallel, masking: none, basic science |
| Enrollment | 30 (Estimated) |
| Sponsor | NYU Langone Health (Other) |
| Conditions | Seizures, Seizure Disorder, Psychogenic Movement Disorder |
| Interventions | Sham TMS3 stimulation, rTMS of left or right angular gyrus (AG) or frontal cortex (FC), Anodal tDCS of left or right AG or FC (Device) |
| Dates | start 2017-07-20, primary completion 2027-05-01 (estimated), completion 2027-05-01 (estimated), first posted 2017-07-28, last updated 2026-09-25 |
| Locations | 1 site in United States |
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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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Healthy Patients | Active comparator | Device: Sham TMS3 stimulation; Device: rTMS of left or right angular gyrus (AG) or frontal cortex (FC); Device: Anodal tDCS of left or right AG or FC | All healthy volunteers will complete the healthy volunteer form, MRI safety screening form, and the Montreal Cognitive Assessment (MOCA). |
| PMD/PNES patients | Active comparator | Device: Sham TMS3 stimulation; Device: rTMS of left or right angular gyrus (AG) or frontal cortex (FC); Device: Anodal tDCS of left or right AG or FC | PMD and PNES subjects will be referred by the treating |
Sex: All, ages: 18 Years to 65 Years, accepts healthy volunteers
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
| Facility | City | Country | Status |
|---|---|---|---|
| New York University School of Medicine | New York, New York | United States | Recruiting |