Cortical Stimulation for Movement Disorders

Overseen By Nalini Jeet

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Must not be taking: Tricyclics, Antiepileptics, CNS active

Disqualifiers: Neurological disorder, Substance abuse, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 3-4 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how the brain controls movement and decision-making, using non-invasive techniques to enhance understanding of these processes. It tests various brain stimulation methods, such as Anodal tDCS (Transcranial Direct Current Stimulation) and rTMS (Repetitive Transcranial Magnetic Stimulation), to determine their effectiveness in managing symptoms of certain movement disorders, like PMD (psychogenic movement disorders) and PNES (psychogenic non-epileptic seizures). The study seeks participants who either have PMD or PNES, confirmed by a neurologist, or healthy individuals fluent in English. Participants should not require changes in their treatment for a few months after the trial begins. As an unphased trial, this study offers participants the opportunity to contribute to groundbreaking research that could enhance understanding and treatment of movement disorders.

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.

What prior data suggests that these methodologies are safe for studying movement disorders?

Research shows that both anodal tDCS and rTMS are generally safe. Studies on anodal transcranial Direct Current Stimulation (tDCS) report no serious side effects, only minor skin issues. In one study with 103 participants, researchers found no negative effects on thinking or movement skills.

Similarly, repetitive Transcranial Magnetic Stimulation (rTMS) is considered safe. The risk of serious side effects is low, with only minor issues like temporary headaches reported. Reviewed data revealed no seizures. Both treatments have been used safely for various conditions, demonstrating they are well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments because they involve innovative brain stimulation techniques that could offer new hope for movement disorder patients. Unlike traditional treatments that often rely on medication to manage symptoms, anodal tDCS and rTMS directly target the brain's angular gyrus (AG) and frontal cortex (FC) to modulate neural activity. This approach could potentially lead to more precise and effective management of movement disorders like PMD and PNES. By focusing on specific brain regions, these treatments aim to improve motor function and reduce symptoms without the side effects commonly associated with medication.

What evidence suggests that this trial's treatments could be effective for movement disorders?

This trial will compare the effects of anodal tDCS and rTMS on movement disorders. Studies have shown that anodal tDCS, a type of brain stimulation, can boost thinking skills and improve movement abilities. It has effectively reduced pain and tiredness and enhanced the quality of life for some patients. Research also suggests that tDCS can help manage emotions by reducing strong reactions to emotional situations.

Similarly, rTMS, another form of brain stimulation, has effectively treated movement problems, especially in conditions like Parkinson's disease. High-frequency rTMS can improve movement symptoms, with some benefits lasting up to a month after treatment. Overall, both anodal tDCS and rTMS show promise in improving movement and thinking abilities. Participants in this trial will receive either anodal tDCS or rTMS to assess their effectiveness in treating movement disorders. ^{6 7 8 9 10}

Who Is on the Research Team?

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.

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?

Group I: PMD/PNES patients Active Control 3 Interventions

PMD and PNES subjects will be referred by the treating

Group II: Healthy Patients Active Control 3 Interventions

All healthy volunteers will complete the healthy volunteer form, MRI safety screening form, and the Montreal Cognitive Assessment (MOCA).

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

Published Research Related to This Trial

Transcranial Direct Current Stimulation (tDCS) has been shown to be safe, with no reports of Serious Adverse Effects or irreversible injuries across over 33,200 sessions involving more than 1,000 subjects, including vulnerable populations.

Safety assessments indicate that the current densities used in conventional tDCS (≤4 milliamperes) are significantly lower than those that could potentially cause brain injury, suggesting that tDCS protocols are well within safe limits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of Transcranial Direct Current Stimulation: Evidence Based Update 2016. Bikson, M., Grossman, P., Thomas, C., et al.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cerebellar and Motor Cortical Transcranial Stimulation Decrease Levodopa-Induced Dyskinesias in Parkinson's Disease. Ferrucci, R., Cortese, F., Bianchi, M., et al.[2019]

High Definition transcranial direct current stimulation (HD-tDCS) is safe and well-tolerated in older adults, with no serious adverse events reported during a study involving 101 participants at stimulation intensities of 2 mA and 3 mA.

The study demonstrated effective blinding, as participants could not accurately distinguish between active and sham stimulation, indicating that HD-tDCS can be reliably used in clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tolerability and blinding of 4x1 high-definition transcranial direct current stimulation (HD-tDCS) at two and three milliamps. Reckow, J., Rahman-Filipiak, A., Garcia, S., et al.[2020]

Anodal Transcranial Direct Current Stimulation (AtDCS) significantly enhances motor cortex activity, as evidenced by increased low alpha and beta band Event-Related Desynchronization (ERD) during a finger tapping task in 10 healthy subjects, compared to Sham and cathodal stimulation (CtDCS).

The study suggests that AtDCS may lead to long-lasting changes in the motor network's functional architecture and local band power, indicating its potential as a therapeutic tool for enhancing motor function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Local and remote effects of transcranial direct current stimulation on the electrical activity of the motor cortical network. Notturno, F., Marzetti, L., Pizzella, V., et al.[2021]

The study involving 26 healthy subjects found that five sessions of anodal transcranial direct current stimulation (tDCS) delivered over 24 hours were safe, with no serious adverse events reported, although mild side effects occurred in 27% of participants.

While 50% of subjects showed a significant increase in motor cortex excitability (as measured by motor evoked potential amplitudes), the response varied among individuals, indicating that not everyone benefits equally from this treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and effects on motor cortex excitability of five anodal transcranial direct current stimulation sessions in 24hours. Zappasodi, F., Musumeci, G., Navarra, R., et al.[2019]

In a study involving 24 subjects with treatment-resistant major depression (TRD), transcranial direct current stimulation (tDCS) using anodal stimulation to the left dorsolateral prefrontal cortex (DLPFC) and cathodal stimulation to the right DLPFC did not show a significant difference in remission rates compared to sham tDCS.

The treatment was well tolerated with no significant differences in side effects between the active and sham groups, but methodological limitations suggest caution in interpreting the results and highlight the need for further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized double-blind sham-controlled study of transcranial direct current stimulation for treatment-resistant major depression. Blumberger, DM., Tran, LC., Fitzgerald, PB., et al.[2021]

Anodal transcranial direct current stimulation (a-tDCS) can enhance motor evoked potentials (MEPs) in the forearm muscle (Extensor Carpi Radialis) depending on the latency difference in I-wave recruitment, indicating that individual differences can affect treatment outcomes.

In a study of 18 healthy adults, those with smaller MEP latency differences experienced increased MEPs after a-tDCS, while those with larger differences showed suppressed MEPs, suggesting that I-wave recruitment is a key factor in the effectiveness of a-tDCS for distal muscles but not for proximal muscles like the Biceps Brachii.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

'I-wave' Recruitment Determines Response to tDCS in the Upper Limb, but Only So Far. McCambridge, AB., Stinear, JW., Byblow, WD.[2018]

Anodal transcranial direct current stimulation (tDCS) applied to the left primary motor cortex increased activation in both the primary motor cortex (M1) and the supplementary motor area (SMA) shortly after stimulation, suggesting a potential for enhancing motor-related cortical activity.

Cathodal tDCS, on the other hand, increased activation in the contralateral M1 and dorsal premotor cortex (PMd), indicating that inhibitory stimulation can also enhance connectivity and activation in motor areas, which may have implications for neurorehabilitation strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modulation of movement-associated cortical activation by transcranial direct current stimulation. Stagg, CJ., O'Shea, J., Kincses, ZT., et al.[2022]

The study assessed the safety of 1.5-mA transcranial direct current stimulation (tDCS) on 49 fasting healthy individuals during Ramadan, finding no serious adverse events or discomfort during the sessions.

There was no significant difference in side effects between active tDCS and sham stimulation, indicating that the tDCS protocol used is safe for fasting adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of Transcranial Direct Current Stimulation of Frontal, Parietal, and Cerebellar Regions in Fasting Healthy Adults. Almousa, A., Alajaji, R., Alaboudi, M., et al.[2020]

The study compared the effects of unihemispheric concurrent dual-site anodal transcranial Direct Current Stimulation (a-tDCSUHCDS) and conventional M1 a-tDCS on motor learning in healthy individuals, showing that a-tDCSUHCDS led to better retention of motor skills after training.

While all groups improved during training, only the a-tDCSUHCDS group showed significant skill retention compared to the sham group, suggesting that this technique may enhance long-term motor learning and could be beneficial in neuro-rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Differential Effects of Unihemispheric Concurrent Dual-Site and Conventional tDCS on Motor Learning: A Randomized, Sham-Controlled Study. Talimkhani, A., Abdollahi, I., Mohseni-Bandpei, MA., et al.[2022]

Transcranial direct current stimulation (tDCS) can significantly enhance functional connectivity in the brain, particularly increasing the connection between the left thalamus and the primary motor cortex after stimulation, indicating its potential to modulate motor circuits.

The study provides direct evidence that tDCS affects cortico-striatal and thalamo-cortical circuits, with anodal stimulation over the primary motor cortex strengthening connections, while cathodal stimulation can decrease connectivity, showcasing the nuanced effects of tDCS on brain networks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modulating cortico-striatal and thalamo-cortical functional connectivity with transcranial direct current stimulation. Polanía, R., Paulus, W., Nitsche, MA.[2022]

Anodal transcranial direct current stimulation (tDCS) over the left primary motor cortex enhances corticospinal excitability, while cathodal tDCS reduces it, as evidenced by changes in motor evoked potential (MEP) amplitude.

tDCS modulates cortical reactivity in a polarity-dependent manner, with anodal stimulation increasing neuronal activity and cathodal stimulation decreasing it, suggesting that tDCS can influence synaptic efficacy in the motor cortex.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Excitability modulation of the motor system induced by transcranial direct current stimulation: a multimodal approach. Pellicciari, MC., Brignani, D., Miniussi, C.[2013]

Transcranial direct current stimulation (tDCS) is generally considered safe, with mild and transient adverse effects reported in clinical trials, but the frequency and relationship of these effects with clinical variables remain unclear due to selective reporting bias.

Out of 209 studies reviewed, 117 mentioned adverse effects, with common issues like itching and tingling reported more frequently in the active tDCS group, although these differences were not statistically significant.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review on reporting and assessment of adverse effects associated with transcranial direct current stimulation. Brunoni, AR., Amadera, J., Berbel, B., et al.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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 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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of More-Affected vs. Less-Affected Motor Cortex tDCS in Parkinson's Disease. Cosentino, G., Valentino, F., Todisco, M., et al.[2020]

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