transcranial direct current stimulation for Anxiety and Fear

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Anxiety and Fear+1 Moretranscranial direct current stimulation - Device
Eligibility
18 - 65
All Sexes
What conditions do you have?
Select

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

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

Side Effects for

Transcranial Direct Current Stimulation
11%scalp burn
This histogram enumerates side effects from a completed 2011 Phase 1 & 2 trial (NCT00481988) in the Transcranial Direct Current Stimulation ARM group. Side effects include: scalp burn with 11%.

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: Device
sham transcranial direct current stimulation
Device
ShamComparator Group · 1 Intervention: transcranial direct current stimulation · Intervention Types: Device
Treatment
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?
Oklahoma100.0%
How old are they?
18 - 65100.0%
What site did they apply to?
Laureate Institute for Brain Research100.0%
What portion of applicants met pre-screening criteria?
Met criteria66.7%
Did not meet criteria33.3%

How responsive is this trial?

Typically responds via
Email100.0%