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Behavioural Intervention

tDCS for Depression

N/A

Waitlist Available

Led By Giuseppina Pilloni, 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

Be older than 18 years old

Must not have

Any skin disorder or skin sensitive area near stimulation locations

Seizure disorder or recent (<5 years) seizure history

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to week 4

Summary

This trial tests a new treatment where a small electrical current is applied to the brain using a special headset, done under remote supervision. It targets people with mild to moderate depression to see if it can help improve their mood. The treatment aims to 'reset' brain activity in areas linked to mood regulation.

Who is the study for?

This trial is for 100 people with mild to moderate depression. Participants will use a special headset at home for 10 days, following a remotely supervised protocol. They must not have certain conditions that would exclude them from the study, but specific exclusion criteria are not listed here.

What is being tested?

The study tests if Transcranial Direct Current Stimulation (tDCS) can help with depression by comparing active tDCs against sham (fake) treatment. It's double-blinded, meaning neither participants nor researchers know who gets real or sham treatment until after the results are collected.

What are the potential side effects?

Possible side effects of tDCS may include discomfort at the electrode site, itching, tingling, headache, fatigue and in rare cases seizures; however exact side effects related to this specific trial's protocol are not detailed.

Eligibility Criteria

Exclusion Criteria

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

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I have skin conditions or sensitive skin near where a medical device would be placed.

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

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I have a major neurological, psychiatric, or medical condition.

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I have not been diagnosed with bipolar depression, psychotic disorder, or substance abuse.

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I am not taking medications like beta-blockers that affect heart rate.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to week 4

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to week 4

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to week 4 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Average HR Measured Using i-HR Data Logger

Average Heart Rate (HR) Measured Using Polar H10 Chest Monitor

Secondary study objectives

Change in Montgomery Ӓsberg Depression Rating Scale (MADRS) Score

Change in Positive and Negative Affect Schedule (PANAS-SF): Negative Affect Score

Change in Positive and Negative Affect Schedule (PANAS-SF): Positive Affect Score

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Active tDCSExperimental Treatment1 Intervention

Participants randomized to the Active tDCS arm will complete 10 sessions of 30-minute active remotely supervised (RS)-tDCS with chest strap and impedance-based HRV data collection over the course of approximately 2-4 weeks.

Group II: Sham tDCSPlacebo Group1 Intervention

Participants randomized to the Active tDCS arm will complete 10 sessions of 30-minute sham RS-tDCS with chest strap and impedance-based HRV data collection over the course of approximately 2-4 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Active Transcranial Direct Current Stimulation (tDCS)

2020

N/A

~160

0 / 5Eligibility criteria met