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Corticosteroid
Cortical Stimulation for Movement Disorders
N/A
Recruiting
Led By Biyu He, MD
Research Sponsored by NYU Langone Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 minutes
Awards & highlights
Study Summary
This trial is investigating movement intention and volition in order to improve understanding and treatments for PMD symptoms.
Who is the study for?
This trial is for English-speaking healthy individuals or patients with psychogenic movement disorders (PMD) or psychogenic non-epileptic seizures (PNES), confirmed by a specialist. Participants should not expect treatment changes for 3-6 months and must not have significant neurological issues, chronic conditions, head trauma, substance abuse, certain psychiatric conditions, pregnancy, metal in the body, be taking specific medications or have inflammatory/autoimmune disorders.Check my eligibility
What is being tested?
The study tests how brain stimulation affects movement intention. It uses sham TMS3 (fake stimulation), real Transcranial Magnetic Stimulation (rTMS) of the angular gyrus or frontal cortex, and Anodal Transcranial Direct Current Stimulation (tDCS) on these areas to gather data that may help develop treatments for PMD symptoms.See study design
What are the potential side effects?
Potential side effects from rTMS and tDCS include discomfort at the stimulation site, headache, lightheadedness, temporary hearing changes due to equipment noise during rTMS; rare risks involve seizures. Sham TMS3 has no active components but may cause placebo effects.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 minutes
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 minutes
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Changes in signal intensity measured during EEG recording
Changes in signal intensity measured during MEG
Changes in signal intensity measured using of tDCS
Trial Design
2Treatment groups
Active Control
Group I: PMD/PNES patientsActive Control3 Interventions
PMD and PNES subjects will be referred by the treating
Group II: Healthy PatientsActive Control3 Interventions
All healthy volunteers will complete the healthy volunteer form, MRI safety screening form, and the Montreal Cognitive Assessment (MOCA).
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Who is running the clinical trial?
NYU Langone HealthLead Sponsor
1,368 Previous Clinical Trials
839,696 Total Patients Enrolled
Biyu He, MDPrincipal InvestigatorNYU Langone Health
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a long-term or worsening medical condition.I have been diagnosed with a seizure disorder.You have metal objects or devices in your head.I do not have a significant neurological disorder that could affect study results.I have a neurological condition other than PMD or PNES, such as stroke or unexplained fainting.I haven't had any major illnesses or autoimmune disorders in the last 6 months.I am taking certain antidepressants or drugs listed as high-risk by Rossi et al., 2009.My neurologist confirmed I have PMD/PNES and likely won't need treatment changes soon.I am currently taking certain antidepressants, antiepileptic, or other specific CNS-active drugs.I have not been diagnosed with an inflammatory or autoimmune disorder in the last 6 months.I have had a serious head injury in the past.You have a history of mental health conditions that could make it hard to understand the study results.I have had a serious head injury in the past.You currently have a problem with using drugs or alcohol.You have any metal device implanted in your body, like a pacemaker or spinal cord stimulator.I have experienced visual hallucinations in the last 6 months.You have a history of severe, uncontrolled head movements.You have any other metal objects in your body that could make the study risky (like dental prosthetics).You have been diagnosed with dementia or have a Montreal Cognitive Assessment (MoCA) score of 24 or lower.
Research Study Groups:
This trial has the following groups:- Group 1: PMD/PNES patients
- Group 2: Healthy Patients
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Will this experiment be able to test subjects that are over the age of 40?
"The age limits for this clinical trial are 18-65."
Answered by AI
Are there any medical prerequisites for potential candidates of this trial?
"To qualify for this clinical trial, potential participants must suffer from seizures and be between 18-65 years old. In total, the researchers are looking to enroll 80 individuals."
Answered by AI
Are there any more room for participants in this experiment?
"That is correct, according to the most recent information available on clinicaltrials.gov, this study is still looking for 80 individuals to participate. The study was first posted on 7/20/2017, and the 1 site is currently enrolling patients."
Answered by AI
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