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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
Awards & highlights

Summary

This trial will involve recruiting 100 people with mild to moderate depression to participate in a study using a new technology called tDCS. Participants will undergo 10 days of 30-minute tDCS

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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Average HR Measured Using i-HR Data Logger
Average Heart Rate (HR) Measured Using Polar H10 Chest Monitor
Secondary outcome measures
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

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Who is running the clinical trial?

NYU Langone HealthLead Sponsor
1,379 Previous Clinical Trials
848,018 Total Patients Enrolled
22 Trials studying Depression
1,502 Patients Enrolled for Depression
National Institute for Biomedical Imaging and Bioengineering (NIBIB)NIH
90 Previous Clinical Trials
19,828 Total Patients Enrolled
Giuseppina Pilloni, PhDPrincipal InvestigatorNYU Langone Health
~67 spots leftby Nov 2027
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