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 project is a double-blind, sham-controlled, parallel-arm, randomized controlled trial. We will recruit n=170 people living with MS, who are experiencing an episode of depression in the context of a major depressive episode (MDE). Using our remotely supervised (RS) tDCS protocol, enrolled participants will complete 30 days of 30-minute tDCS (2.0, DLPFC left anodal) while listening to mindfulness meditation. Over the course of the study, participants will complete assessments of depression and MS symptoms. Participants will be randomized 1:1 active:sham tDCS.

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.

Is transcranial direct current stimulation (tDCS) safe for humans?

Research shows that transcranial direct current stimulation (tDCS) is generally safe for humans, with no serious adverse effects reported in over 33,200 sessions and 1,000 subjects, including vulnerable populations. The amount of electricity used in tDCS is much lower than levels that could cause brain injury, ensuring safety when used at standard intensities and durations. ^{1 2 3 4 5}

How does the treatment transcranial direct current stimulation (tDCS) differ from other treatments for depression in multiple sclerosis?

Transcranial direct current stimulation (tDCS) is unique because it involves delivering weak electrical currents through the scalp to modulate brain activity, which can improve mood, cognitive function, and reduce fatigue in multiple sclerosis patients. Unlike traditional drug treatments, tDCS is non-invasive and can have lasting effects on brain excitability without the need for medication. ^{2 3 6 7 8}

What data supports the effectiveness of the treatment Transcranial Direct Current Stimulation (tDCS) for depression in Multiple Sclerosis?

Research shows that tDCS can improve mood disturbances and reduce fatigue in people with multiple sclerosis, which often includes symptoms of depression. A systematic review found moderate to strong positive effects of tDCS on mood, suggesting it may help with depression in MS patients. ^{2 3 6 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 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]

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]

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]

Citations

1. Netherlands pubmed.ncbi.nlm.nih.gov

Transcranial direct current stimulation (tDCS) for fatigue in multiple sclerosis. [2014]

2. England pubmed.ncbi.nlm.nih.gov

Comparing the effects of multi-session anodal trans-cranial direct current stimulation of primary motor and dorsolateral prefrontal cortices on fatigue and quality of life in patients with multiple sclerosis: a double-blind, randomized, sham-controlled trial. [2022]

3. Austria pubmed.ncbi.nlm.nih.gov

Bifrontal transcranial direct current stimulation modulates fatigue in multiple sclerosis: a randomized sham-controlled study. [2021]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Effects of Transcranial Direct Current Stimulation on Cognition, Mood, Pain, and Fatigue in Multiple Sclerosis: A Systematic Review and Meta-Analysis. [2021]

5. Scotland 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. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Safety of Transcranial Direct Current Stimulation: Evidence Based Update 2016. [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Prefrontal tDCS Decreases Pain in Patients with Multiple Sclerosis. [2022]

8. Korea (South) pubmed.ncbi.nlm.nih.gov

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

9. France pubmed.ncbi.nlm.nih.gov

Effects of transcranial direct current stimulation on cognitive dysfunction in multiple sclerosis. [2021]