Modulating Movement Intention Via Cortical Stimulation

Seizures Clinical Trial

Official title:

Modulating Movement Intention Via Cortical Stimulation in Healthy Subjects and Patients With Psychogenic Movement Disorders and Non-epileptic Seizures

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03233399
• Other study ID #: 16-01859
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Epilepsy
• Movement Disorders
• Psychogenic Movement Disorder
• Seizure Disorder
• Seizures

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