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New treatment option for Seizures
Official title Modulating Movement Intention Via Cortical Stimulation
ClinicalTrials.gov ID: NCT03233399
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65. Healthy volunteers may be eligible.
You may be able to join if
- (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
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.