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Brain Stimulation

tACS for Depression (GLADIATOR2 Trial)

N/A
Waitlist Available
Led By David Rubinow, MD
Research Sponsored by University of North Carolina, Chapel Hill
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, day 5
Awards & highlights

GLADIATOR2 Trial Summary

This trial will use brain stimulation to study its effects on brain activity and mood in patients with Major Depressive Disorder.

Eligible Conditions
  • Depression

GLADIATOR2 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, two-week follow-up visit
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, two-week follow-up visit for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Electroencephalography
Change in the amplitude of left frontal alpha oscillations measured during resting-state EEG recordings from baseline to two-week follow-up of stimulation.
Secondary outcome measures
Correlation between changes in the amplitude of left frontal alpha oscillations and changes in symptoms of depression from baseline to two-week follow-up
Correlation between changes in the amplitude of left frontal alpha oscillations from baseline to day 5 of intervention and changes in symptoms of depression.
Correlation between changes in the amplitude of left frontal alpha oscillations from baseline to two-week follow-up and depression symptoms.

GLADIATOR2 Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: alpha Transcranial alternating current stimulation (tACS).Experimental Treatment1 Intervention
10 Hz tACS with a zero-to-peak amplitude of 1 mA for 40 minutes.
Group II: Sham stimulationPlacebo Group1 Intervention
20 seconds of ramp-up, 40 seconds of 10 Hz tACS with zero-to-peak amplitude of 1 mA, and 20 seconds of ramp-down for a total of 80 seconds of stimulation.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
tACS
2022
Completed Early Phase 1
~1200

Find a Location

Who is running the clinical trial?

University of North Carolina, Chapel HillLead Sponsor
1,504 Previous Clinical Trials
4,187,642 Total Patients Enrolled
54 Trials studying Depression
33,678 Patients Enrolled for Depression
Foundation of Hope, North CarolinaOTHER
15 Previous Clinical Trials
532 Total Patients Enrolled
5 Trials studying Depression
145 Patients Enrolled for Depression
David Rubinow, MDPrincipal InvestigatorUniversity of North Carolina at Chapel Hill - Department of Psychiatry

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this clinical research include participants aged 55 or older?

"This trial is seeking patients aged between 18 and 70 years old to participate."

Answered by AI

What objectives is this clinical trial hoping to accomplish?

"The main outcome of this trial, evaluated at Baseline and Day 5, will be the alteration in left frontal alpha oscillation amplitudes measured through eyes-open EEG recordings. Secondary objectives include exploring correlations between changes in depression symptoms determined by Hamilton Depression Rating Scale (HDRS) scores from Baseline to two weeks post treatment with variations in above mentioned amplitude as well as a correlation analysis between change in amplitude values at baseline and day 5. Fourier transformation is used on 2 second signal epochs collected during resting state for calculating these amplitudes which are then averaged over all left frontal electrodes."

Answered by AI

How many participants are currently registered in this research endeavor?

"Affirmative. According to clinicaltrials.gov, the research project was made public on June 9th 2021 and has recently been updated on May 10th 2022. 20 patients are required for participation from a single location across the country."

Answered by AI

Are individuals being actively sought as participants in this research endeavor?

"This trial is presently recruiting patients, as recorded on clinicaltrials.gov. It was initially published on June 9th 2021 and underwent its most recent update May 10th 2022."

Answered by AI

Are the requirements for joining this medical experiment within my grasp?

"This clinical trial is enrolling 20 volunteers between 18 and 70 years old with a DSM-IV diagnosis of major depressive disorder. To be considered, the applicant must have an HRDS-17 score higher than 8, demonstrate low suicide risk on the HDRS-17 and C-SSRS assessments, as well as possess enough mental capacity to comprehend all associated risks and benefits (informed consent)."

Answered by AI
~5 spots leftby Apr 2025