30 Participants Needed

Cortical Stimulation for Movement Disorders

SS
AE
NJ
Overseen ByNalini Jeet
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial requires that you do not take tricyclic antidepressants or certain CNS (central nervous system) active drugs that are considered a strong potential hazard. If you are on these medications, you may need to stop them to participate.

Is cortical stimulation for movement disorders generally safe in humans?

Research shows that transcranial direct current stimulation (tDCS) is generally safe in humans, with no reports of serious adverse effects in over 33,200 sessions. Common mild side effects include itching, tingling, and headache, but these are not significantly different from placebo treatments.12345

How does the treatment 'Cortical Stimulation for Movement Disorders' differ from other treatments for movement disorders?

This treatment is unique because it uses noninvasive brain stimulation techniques like transcranial direct current stimulation (tDCS) and repetitive transcranial magnetic stimulation (rTMS) to alter brain activity and connectivity, potentially improving movement control. Unlike traditional drug therapies, these methods directly target brain regions involved in movement, offering a novel approach for managing movement disorders.678910

What data supports the effectiveness of the treatment for movement disorders?

Research shows that transcranial direct current stimulation (tDCS) can improve motor symptoms and reduce dyskinesias (involuntary movements) in Parkinson's disease, suggesting it may help with other movement disorders as well.1112131415

Who Is on the Research Team?

BH

Biyu He, MD

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

(Healthy Controls) Fluent in English
My neurologist confirmed I have PMD/PNES and likely won't need treatment changes soon.

Exclusion Criteria

You have a long-term or worsening medical condition.
Pregnancy
I have been diagnosed with a seizure disorder.
See 17 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Treatment

Participants undergo TMS and tDCS to explore effects on movement intention and neural activity

3-4 weeks
Multiple sessions (in-person)

Neuroimaging and Data Collection

Neuroimaging recordings and data collection for hypotheses development

3 hours per session
Multiple sessions (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Anodal tDCS of left or right AG or FC
  • rTMS of left or right angular gyrus (AG) or frontal cortex (FC)
  • Sham TMS3 stimulation
Trial Overview 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.
How Is the Trial Designed?
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).

Find a Clinic Near You

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials
1,431
Recruited
838,000+

Published Research Related to This Trial

In a study involving 14 Parkinson's Disease patients, anodal transcranial direct current stimulation (tDCS) on the more-affected motor cortex significantly improved motor performance, indicating its potential as an effective treatment for asymmetric motor symptoms.
Cathodal tDCS on the less-affected motor cortex also showed beneficial effects, suggesting that targeted stimulation can modulate cortical excitability and improve motor function in patients with asymmetric symptoms.
Effects of More-Affected vs. Less-Affected Motor Cortex tDCS in Parkinson's Disease.Cosentino, G., Valentino, F., Todisco, M., et al.[2020]
Bilateral anodal transcranial direct current stimulation (tDCS) significantly improved balance and reduced fear of falling in 18 patients with Parkinson's disease after 10 sessions over 2 weeks, as measured by the Berg Balance Scale and Falls Efficacy Scale-International.
The study demonstrated that bilateral tDCS is a safe and effective rehabilitation method for addressing balance issues in Parkinson's patients, with statistically significant improvements observed in balance and walking tests.
Bilateral anodal transcranial direct current stimulation effect on balance and fearing of fall in patient with Parkinson's disease.Hadoush, H., Al-Jarrah, M., Khalil, H., et al.[2018]
In a study involving nine patients with Parkinson's disease, five consecutive days of anodal transcranial direct current stimulation (tDCS) over the motor cortex and cerebellum significantly improved levodopa-induced dyskinesias, as measured by the UPDRS IV scale (p < 0.001).
While the study showed promising results for reducing dyskinesias, other motor and cognitive symptoms did not show significant changes with either tDCS or sham treatment, indicating that tDCS may specifically target dyskinesias in Parkinson's patients.
Cerebellar and Motor Cortical Transcranial Stimulation Decrease Levodopa-Induced Dyskinesias in Parkinson's Disease.Ferrucci, R., Cortese, F., Bianchi, M., et al.[2019]

Citations

Effects of More-Affected vs. Less-Affected Motor Cortex tDCS in Parkinson's Disease. [2020]
Bilateral anodal transcranial direct current stimulation effect on balance and fearing of fall in patient with Parkinson's disease. [2018]
Cerebellar and Motor Cortical Transcranial Stimulation Decrease Levodopa-Induced Dyskinesias in Parkinson's Disease. [2019]
A randomized double-blind sham-controlled study of transcranial direct current stimulation for treatment-resistant major depression. [2021]
Differential Effects of Unihemispheric Concurrent Dual-Site and Conventional tDCS on Motor Learning: A Randomized, Sham-Controlled Study. [2022]
Safety and effects on motor cortex excitability of five anodal transcranial direct current stimulation sessions in 24hours. [2019]
Tolerability and blinding of 4x1 high-definition transcranial direct current stimulation (HD-tDCS) at two and three milliamps. [2020]
Safety of Transcranial Direct Current Stimulation of Frontal, Parietal, and Cerebellar Regions in Fasting Healthy Adults. [2020]
A systematic review on reporting and assessment of adverse effects associated with transcranial direct current stimulation. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
Safety of Transcranial Direct Current Stimulation: Evidence Based Update 2016. [2022]
11.United Statespubmed.ncbi.nlm.nih.gov
'I-wave' Recruitment Determines Response to tDCS in the Upper Limb, but Only So Far. [2018]
12.United Statespubmed.ncbi.nlm.nih.gov
Local and remote effects of transcranial direct current stimulation on the electrical activity of the motor cortical network. [2021]
Modulation of movement-associated cortical activation by transcranial direct current stimulation. [2022]
14.United Statespubmed.ncbi.nlm.nih.gov
Modulating cortico-striatal and thalamo-cortical functional connectivity with transcranial direct current stimulation. [2022]
15.United Statespubmed.ncbi.nlm.nih.gov
Excitability modulation of the motor system induced by transcranial direct current stimulation: a multimodal approach. [2013]
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