Study Summary
This trial is testing whether transcranial direct current stimulation (tDCS) can help people with anxious depression by targeting their threat sensitivity.
Eligible Conditions
- Anxiety and Fear
- Depression
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 2 Secondary · Reporting Duration: immediately after intervention
immediately after intervention
The difference between amygdala Blood-Oxygen-Level-Dependent (BOLD) functional Magnetic Resonance Imaging (fMRI) activation to fearful faces compared to neutral faces
The difference between frontoparietal Blood-Oxygen-Level-Dependent (BOLD) functional Magnetic Resonance Imaging (fMRI) activation to fearful faces compared to neutral faces
The difference between startle reflex measured by electromyography (EMG) under threat of unpredictable shock compared to no threat of shock
Trial Safety
Safety Progress
Side Effects for
Transcranial Direct Current Stimulation
11%scalp burn
Trial Design
2 Treatment Groups
active transcranial direct current stimulation
1 of 2
sham transcranial direct current stimulation
1 of 2
Experimental Treatment
Non-Treatment Group
124 Total Participants · 2 Treatment Groups
Primary Treatment: transcranial direct current stimulation · Has Placebo Group · N/A
active transcranial direct current stimulation
Device
Experimental Group · 1 Intervention: transcranial direct current stimulation · Intervention Types: Devicesham transcranial direct current stimulation
Device
ShamComparator Group · 1 Intervention: transcranial direct current stimulation · Intervention Types: DeviceTreatment
First Studied
Drug Approval Stage
How many patients have taken this drug
transcranial direct current stimulation
2019
Completed Phase 3
~910
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: immediately after intervention
Who is running the clinical trial?
National Institute of General Medical Sciences (NIGMS)NIH
221 Previous Clinical Trials
91,018 Total Patients Enrolled
Laureate Institute for Brain Research, Inc.Lead Sponsor
41 Previous Clinical Trials
4,712 Total Patients Enrolled
Maria Ironside, DPhilPrincipal InvestigatorLaureate Institute for Brain Research
Eligibility Criteria
Age 18 - 65 · All Participants · 4 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have normal or corrected to normal vision/hearing.
You have a minimum score of 8 on the OASIS anxiety scale.
Who else is applying?
What state do they live in?
| Oklahoma | 100.0% |
How old are they?
| 18 - 65 | 100.0% |
What site did they apply to?
| Laureate Institute for Brain Research | 100.0% |
What portion of applicants met pre-screening criteria?
| Met criteria | 66.7% |
| Did not meet criteria | 33.3% |
How responsive is this trial?
Typically responds via
| 100.0% | |
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Conditions
Cancer Related
Treatments