What side effects are associated with this type of intervention?

Common treatments for Multiple Sclerosis (MS) that are similar to Dorsolateral Prefrontal Cortex (DLPFC) Transcranial Direct Current Stimulation (tDCS) include Transcranial Magnetic Stimulation (TMS). The side effects of these neuromodulatory treatments are generally mild and may include headaches, scalp discomfort at the stimulation site, and tingling sensations. More serious side effects are rare but can include mood changes and, in very rare cases, seizures. These treatments are generally well-tolerated, but individual responses can vary, and it is important to discuss potential risks with a healthcare provider.

What prior FDA approvals exist?

The FDA has approved several treatments for Multiple Sclerosis (MS) that primarily focus on modulating the immune system to reduce disease activity and progression. These include disease-modifying therapies (DMTs) such as interferon beta-1a (Avonex, Rebif), interferon beta-1b (Betaseron, Extavia), glatiramer acetate (Copaxone), and more recent oral medications like fingolimod (Gilenya), dimethyl fumarate (Tecfidera), and siponimod (Mayzent). While these treatments do not specifically target the Dorsolateral Prefrontal Cortex (DLPFC) or use Transcranial Direct Current Stimulation (tDCS), they aim to manage the overall disease process and its symptoms, including cognitive and emotional dysfunctions associated with MS.

What other types of research exist?

Promising alternatives to DLPFC tDCS for Multiple Sclerosis patients include: 1) Repetitive Transcranial Magnetic Stimulation (rTMS), which has shown efficacy in reducing depressive symptoms and improving cognitive functions in various neurological conditions. 2) Deep Brain Stimulation (DBS), particularly targeting areas like the thalamus or basal ganglia, which may help in managing motor symptoms and potentially cognitive aspects of MS. 3) Vagus Nerve Stimulation (VNS), which has been explored for its anti-inflammatory effects and potential benefits in neurodegenerative diseases. These alternatives are being actively researched and may offer new avenues for symptom management in MS patients.

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Transcranial Direct Current Stimulation

Telehealth tDCS + Mindfulness for Cannabis Use Disorder

Q: What is the mechanism of action of this treatment?

The most common treatments for Multiple Sclerosis (MS) include disease-modifying therapies (DMTs) such as interferons, glatiramer acetate, and oral medications like dimethyl fumarate. These treatments primarily work by modulating the immune system to reduce inflammation and prevent immune cells from attacking the myelin sheath, which is crucial for nerve function. For example, interferons reduce the frequency of inflammatory episodes, while glatiramer acetate mimics myelin protein to divert immune attacks. Dimethyl fumarate activates the Nrf2 pathway, providing neuroprotection and reducing oxidative stress. These mechanisms are vital for MS patients as they help manage symptoms, reduce relapse rates, and slow disease progression. Similarly, Dorsolateral Prefrontal Cortex (DLPFC) Transcranial Direct Current Stimulation (tDCS) aims to modulate neuronal activity in the DLPFC to regulate cognitive and emotional functions, potentially offering a non-pharmacological approach to alleviate distress and cognitive symptoms in MS patients.

N/A

Waitlist Available

Led By Leigh Charvet, PhD

Research Sponsored by NYU Langone Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

All medications stable for ≥ 1 month prior to enrollment and throughout the trial

Definite MS diagnosis, relapsing remitting (RRMS) subtype

Must not have

Seizure disorder or recent (<5 years) seizure history

Meets DSM-V criteria for current panic disorder, obsessive-compulsive disorder, post-traumatic stress syndrome, bipolar affective disorder, schizophrenia, dissociate disorders, and any other psychotic disorder or organic mental disorder

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 6, month 3

Summary

This trial uses mild electrical brain stimulation to help people with a specific type of multiple sclerosis, cannabis dependency, and high stress. The goal is to reduce their stress levels and need for cannabis by improving their decision-making and emotional control. Non-invasive brain stimulation techniques have shown promise in reducing cravings and consumption in similar conditions.

Who is the study for?

This trial is for adults aged 21-65 with Relapse Remitting Multiple Sclerosis (RRMS), mild to moderate distress, and Cannabis Use Disorder who want to reduce or stop cannabis use. Participants must be stable on medications, fluent in English, able to use mobile devices and have internet access.

What is being tested?

The study tests if brain stimulation (tDCS) can lower distress and cannabis use in RRMS patients with CUD. It involves a real tDCS group versus a sham (fake) treatment group, along with mindfulness practices. There will be 46 participants.

What are the potential side effects?

tDCS may cause discomfort at the stimulation site, itching, tingling, headache or fatigue during or after treatment. Mindfulness practice is generally considered safe but could potentially bring up emotional discomfort.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My medications have been the same for at least a month.

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I have been diagnosed with relapsing-remitting multiple sclerosis.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had seizures or a seizure disorder in the last 5 years.

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I do not have a current diagnosis of severe mental health conditions like schizophrenia or bipolar disorder.

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I have metal implants in my head or neck.

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I have skin issues near where a medical device would be placed.

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I do not have a major neurological, psychiatric, or other medical condition besides MS.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 6, month 3

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 6, month 3

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 6, month 3 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Age of Onset of Cannabis Use

Secondary study objectives

Change in Cannabis Withdrawal Scale (CWS) Score

Change in Frequency of Cannabis Use

Change in Kessler Psychological Distress Scale (K10) Score

+3 more

Side effects data

From 2018 Phase 2 trial • 54 Patients • NCT01726673

back pain flair up

Myasthenia Gravis

100%

80%

60%

40%

20%

Study treatment Arm

tDCS + Robotic Arm Therapy

tDCS Sham + Robotic Arm Therapy

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Active tDCS + MindfulnessExperimental Treatment2 Interventions

Group II: Sham tDCS + MindfulnessPlacebo Group2 Interventions

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Multiple Sclerosis (MS) include disease-modifying therapies (DMTs) such as interferons, glatiramer acetate, and oral medications like dimethyl fumarate. These treatments primarily work by modulating the immune system to reduce inflammation and prevent immune cells from attacking the myelin sheath, which is crucial for nerve function. For example, interferons reduce the frequency of inflammatory episodes, while glatiramer acetate mimics myelin protein to divert immune attacks. Dimethyl fumarate activates the Nrf2 pathway, providing neuroprotection and reducing oxidative stress. These mechanisms are vital for MS patients as they help manage symptoms, reduce relapse rates, and slow disease progression. Similarly, Dorsolateral Prefrontal Cortex (DLPFC) Transcranial Direct Current Stimulation (tDCS) aims to modulate neuronal activity in the DLPFC to regulate cognitive and emotional functions, potentially offering a non-pharmacological approach to alleviate distress and cognitive symptoms in MS patients.

Effects of left DLPFC versus right PPC tDCS on multiple sclerosis fatigue.