SeizuresNCT03233399
Modulating Movement Intention Via Cortical Stimulation
A study testing rTMS of left or right angular gyrus (AG) or frontal cortex (FC) and Anodal tDCS of left or right AG or FC in people with Seizures and Seizure Disorder, run by NYU Langone Health at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Seizures, Seizure Disorder, Psychogenic Movement Disorder
- What is being tested?
- rTMS of left or right angular gyrus (AG) or frontal cortex (FC) and Anodal tDCS of left or right AG or FC
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jul 2017to May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- (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
Who cannot join
- 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
Show all 22Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
New York University School of Medicine
New York, New York, 10016
Steven Stork, 212 263 0001, steven.stork@nyumc.org
Biyu He, MD
About this study
Official title: Modulating Movement Intention Via Cortical Stimulation in Healthy Subjects and Patients With Psychogenic Movement Disorders and Non-epileptic Seizures
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.
Read the 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.
- Conditions
- Seizures, Seizure Disorder, Psychogenic Movement Disorder
- Being tested
- Sham TMS3 stimulation, rTMS of left or right angular gyrus (AG) or frontal cortex (FC), Anodal tDCS of left or right AG or FC
- Keywords
- Electroencephalography, Magnetoencephalography, Transcranial Magnetic Stimulation
- Medical subject headings
- Seizures, Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sham TMS3 stimulationDevice
half of the subjects will receive sham stimulation first
rTMS of left or right angular gyrus (AG) or frontal cortex (FC)Device
Also called 45 Minutes
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 FCDevice
Also called 30 Minutes
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.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Patients | Active comparator | All healthy volunteers will complete the healthy volunteer form, MRI safety screening form, and the Montreal Cognitive Assessment (MOCA). Receives: 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/PNES patients | Active comparator | PMD and PNES subjects will be referred by the treating Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in signal intensity measured using of tDCS
as a result of altering cerebral perfusion in response to neurophysiologic stimulation
Measured: 30 Minutes
Changes in signal intensity measured during EEG recording
as a result of altering cerebral perfusion in response to neurophysiologic stimulation
Measured: 3 Hours
Changes in signal intensity measured during MEG
as a result of altering cerebral perfusion in response to neurophysiologic stimulation
Measured: 3 Hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2017
- Study start20 Jul 2017
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SeizuresStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Biyu He, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03233399
- Sponsor's protocol ID
- 16-01859
- Status last verified
- Sep 2026
- First submitted
- 24 Jul 2017
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modulating Movement Intention Via Cortical Stimulation in Healthy Subjects and Patients With Psychogenic Movement Disorders and Non-epileptic Seizures
- ClinicalTrials.gov ID
- NCT03233399
- Acronym / sponsor ID
- 16-01859
- Conditions
- Seizures, Seizure Disorder, Psychogenic Movement Disorder
- Keywords
- Electroencephalography, Magnetoencephalography, Transcranial Magnetic Stimulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 20 Jul 2017 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 28 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 FCAll 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 FCPMD and PNES subjects will be referred by the treating |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- (Healthy Controls)
- Fluent in English
- 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
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sham TMS3 stimulationhalf of the subjects will receive sham stimulation first | Device | Healthy Patients, PMD/PNES patients |
| rTMS of left or right angular gyrus (AG) or frontal cortex (FC)Also: 45 MinutesHalf 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. | Device | Healthy Patients, PMD/PNES patients |
| Anodal tDCS of left or right AG or FCAlso: 30 MinutesHalf 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. | Device | Healthy Patients, PMD/PNES patients |
Primary outcome
Changes in signal intensity measured using of tDCS
Time frame: 30 Minutes
as a result of altering cerebral perfusion in response to neurophysiologic stimulation
Changes in signal intensity measured during EEG recording
Time frame: 3 Hours
as a result of altering cerebral perfusion in response to neurophysiologic stimulation
Changes in signal intensity measured during MEG
Time frame: 3 Hours
as a result of altering cerebral perfusion in response to neurophysiologic stimulation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Biyu He, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rTMS of left or right angular gyrus (AG) or frontal cortex (FC) and Anodal tDCS of left or right AG or FC in people with Seizures and Seizure Disorder, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nalini Jeet ((212) 263-0228, Nalini.Jeet@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in signal intensity measured using of tDCS (time frame: 30 Minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.