Transcranial Direct Current Stimulation for Depression in Multiple Sclerosis

Overseen By Shayna Pehel

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: NYU Langone Health

Must be taking: Antidepressants, DMTs

Disqualifiers: Stroke, Bipolar, Diabetes, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 8

Duration: 4 weeks

170 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called transcranial direct current stimulation (tDCS) to assist people with multiple sclerosis (MS) who also experience depression. The goal is to determine if tDCS, combined with mindfulness meditation, can reduce depression symptoms. Participants will receive either real tDCS or a sham version to compare results. The study seeks individuals with MS who have stable symptoms, are on regular medications, and can join remote sessions using a mobile device. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group.

Will I have to stop taking my current medications?

The trial requires that you have been on stable antidepressant and disease-modifying therapies (DMTs) for at least 30 days before joining, so you should not stop taking these medications.

What prior data suggests that this tDCS protocol is safe for people with MS and depression?

Research has shown that transcranial direct current stimulation (tDCS) is generally safe and well-tolerated. Various studies reported mostly mild side effects, such as slight skin irritation or a tingling sensation during the session. No evidence of serious side effects from tDCS exists. Notably, tDCS has been studied for its potential to help with depression, showing some positive effects in reducing symptoms. Specifically, past patients demonstrated that this treatment can be used safely over time without significant issues. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for depression in MS?

Unlike the standard treatments for depression in multiple sclerosis, which often involve medications like antidepressants, transcranial direct current stimulation (tDCS) offers a non-invasive, drug-free alternative. tDCS works by sending a low electrical current to the brain, which can modulate neural activity and potentially improve mood and cognitive function. What makes tDCS particularly exciting is that it pairs this brain stimulation with mindfulness meditation, a combination that could enhance its effectiveness by promoting relaxation and mental well-being. Researchers are eager to see if this innovative approach could provide faster or more sustainable relief compared to traditional methods.

What evidence suggests that transcranial direct current stimulation is effective for depression in multiple sclerosis?

Research has shown that transcranial direct current stimulation (tDCS) might help reduce depression symptoms in some individuals. One study found that tDCS led to noticeable improvements in depression, particularly in certain patient groups. This trial will compare active tDCS with sham tDCS to evaluate its effectiveness in managing depression and fatigue in people with multiple sclerosis (MS). Evidence suggests potential benefits, but some results are mixed, indicating that more research is needed to understand its full potential. Overall, tDCS appears promising, but results can vary among individuals. ^{4 6 7 8 9}

Who Is on the Research Team?

Leigh Charvet, PhD

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

This trial is for people with Multiple Sclerosis (MS) who are also dealing with depression. Participants must be experiencing a major depressive episode to qualify. The study aims to include 170 individuals and requires them to complete daily sessions of tDCS while listening to mindfulness meditation for 30 days.

Inclusion Criteria

Provider Contact: Confirmed access to a local provider that has primary responsibility for the subjects' clinical care, and who is available for contact in case of increased subject risk due to depressive symptoms

I can use mobile devices and join video calls.

My antidepressant and disease treatments have been the same for the last 30 days.

Exclusion Criteria

Substance Use: Nicotine use (e.g., smoking or vaping) within the past 6 months

Implanted Devices or Metal Objects: Presence of metal in the head/neck area (excluding dental fillings) or implanted medical devices (e.g., neurostimulators, pacemakers, defibrillators)

Skin Conditions: Active skin disorders or skin sensitivity near electrode application sites

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 30 days of 30-minute daily (M-F) tDCS sessions paired with mindfulness meditation

4 weeks

Remote sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 weeks

Assessments at Week 8 and Month 3

What Are the Treatments Tested in This Trial?

Interventions

• Transcranial Direct Current Stimulation (tDCS)

Trial Overview

The trial is testing the effectiveness of Transcranial Direct Current Stimulation (tDCS) in treating depression among MS patients. It's a double-blind study, meaning neither participants nor researchers know who gets real or sham treatment. People will be randomly assigned in equal numbers to either active tDCS or a placebo-like sham.

How Is the Trial Designed?

Group I: Active tDCS Experimental Treatment 1 Intervention

Participants will complete 30 x 30 minute daily (M-F) sessions of active tDCS which will be paired with a mindfulness meditation audio track.

Group II: Sham tDCS Placebo Group 1 Intervention

Participants will complete 30 x 30 minute daily (M-F) sessions of sham tDCS which will be paired with a mindfulness meditation audio track.

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

National Multiple Sclerosis Society

Collaborator

Trials

100

Recruited

10,600+

Published Research Related to This Trial

Transcranial direct current stimulation (tDCS) has been found to be safe for use in humans, with no severe complications reported in studies involving both adults and children when applied at intensities of 4 mA or less for up to 60 minutes.

Animal studies indicate that the electrical current used in tDCS is significantly lower than the threshold that could cause permanent changes to brain tissue, suggesting a strong safety profile for this neurorehabilitation method.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of Transcranial Direct Current Stimulation in Neurorehabilitation. Ko, MH.[2023]

Transcranial direct current stimulation (tDCS) has shown positive effects in reducing fatigue symptoms in patients with multiple sclerosis (MS), particularly cognitive fatigue, based on a systematic review of 8 studies.

Most studies reported no serious side effects from tDCS, suggesting it is a safe intervention; however, the variability in treatment protocols and short follow-up periods indicate the need for larger, more standardized studies to confirm its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of tDCS on the fatigue in patients with multiple sclerosis: A systematic review of randomized controlled clinical trials. Ashrafi, A., Mohseni-Bandpei, MA., Seydi, M.[2020]

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 24 patients with multiple sclerosis, anodal transcranial direct current stimulation (tDCS) significantly improved cognitive functions, particularly reasoning and executive functions, compared to a sham treatment.

Despite the cognitive improvements, the study found no significant changes in resting-state brain electrical activity after the tDCS sessions, suggesting that while tDCS may enhance cognitive performance, its effects on brain activity need further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of transcranial direct current stimulation on cognitive dysfunction in multiple sclerosis. Gholami, M., Nami, M., Shamsi, F., et al.[2021]

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