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Brain Stimulation
transcranial direct current stimulation for Anxiety and Fear
N/A
Waitlist Available
Led By Maria Ironside, DPhil
Research Sponsored by Laureate Institute for Brain Research, Inc.
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 immediately after intervention
Awards & highlights
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
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ immediately after intervention
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~immediately after intervention
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The difference between amygdala Blood-Oxygen-Level-Dependent (BOLD) functional Magnetic Resonance Imaging (fMRI) activation to fearful faces compared to neutral faces
Secondary outcome measures
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 Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: active transcranial direct current stimulationExperimental Treatment1 Intervention
The investigators use Soterix mini-CT Stimulator to deliver 30 minutes 2mAmp tDCS to the bilateral DLPFC (optimized lateral electrode placement montage), with the the anode on the left hemisphere and the cathode on the right hemisphere. The electrodes are rubber and are placed in an MRI compatible holder and affixed with conductive paste. The investigators will use a bespoke headstrap to place the electrodes, which are held in place by the conductive paste.
Group II: sham transcranial direct current stimulationPlacebo Group1 Intervention
In the sham stimulation mode, the device shows pseudorandom numbers on the screen that look like real stimulation is being delivered. The device gives a low level of stimulation at the very beginning and at the very end of the stimulation session (30 seconds ramp up and 30 seconds ramp down) in order to recreate the feeling of tingling that subjects perceive at the beginning and end of real stimulation.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
transcranial direct current stimulation
2013
Completed Phase 3
~1430
Find a Location
Who is running the clinical trial?
Laureate Institute for Brain Research, Inc.Lead Sponsor
50 Previous Clinical Trials
5,204 Total Patients Enrolled
1 Trials studying Anxiety and Fear
165 Patients Enrolled for Anxiety and Fear
National Institute of General Medical Sciences (NIGMS)NIH
268 Previous Clinical Trials
248,619 Total Patients Enrolled
Maria Ironside, DPhilPrincipal InvestigatorLaureate Institute for Brain Research
1 Previous Clinical Trials
165 Total Patients Enrolled
1 Trials studying Anxiety and Fear
165 Patients Enrolled for Anxiety and Fear
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a medical condition that is not under control and could affect your ability to take part in the study or affect the study results. This includes conditions related to the brain, heart, lungs, liver, kidneys, metabolism, digestion, immune system, hormones, and mental health.You have a score of at least 8 on the OASIS anxiety scale.You currently have an eating disorder or obsessive-compulsive disorder.You have had thoughts of suicide or attempted suicide within the past two years or have expressed these thoughts to the study team during screening.You cannot have an MRI or tDCS due to certain medical conditions or circumstances.One or more of your family members have had psychotic or bipolar disorder.You are currently taking medications that can significantly affect the results of brain scans.You have a history of severe scalp irritation or skin condition that can affect the integrity of your skin.
Research Study Groups:
This trial has the following groups:- Group 1: active transcranial direct current stimulation
- Group 2: sham transcranial direct current stimulation
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Anxiety and Fear Patient Testimony for trial: Trial Name: NCT04948944 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any current opportunities for clinical participation?
"According to information available on clinicaltrials.gov, recruitment for this study is currently in progress. The trial was initially posted April 13th 2021 and its details were last amended November 9th 2022."
Answered by AI
How many people are currently taking part in this research project?
"Affirmative. According to clinicaltrials.gov, this research study is presently enrolling patients. This trial was initially made available on April 13th 2021 and the most recent update occurred November 9th 2022; 124 participants are required for the study at one specific location."
Answered by AI
Does this investigation provide the opportunity for participants over 30 to join?
"This clinical trial requires participants to have attained the age of consent, aged 18 and above, but not yet reached retirement age. Those below 18 years old are eligible for 275 other trials while elderly candidates can apply for 1,122 separate studies."
Answered by AI
Could I be eligible to enroll in this trial?
"Applicants must be aged 18 to 65 and have a diagnosis of depression in order to qualify for this medical trial. Currently, 124 participants are being sought after."
Answered by AI
Who else is applying?
What state do they live in?
Oklahoma
How old are they?
18 - 65
What site did they apply to?
Laureate Institute for Brain Research
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
0
Why did patients apply to this trial?
I've tried every drug and I need to leave the house so I can get on with my life!!
PatientReceived 2+ prior treatments
Disabled veteran of war diagnosed MDD with anxiety and fear and wonder if this trial would be good for my psychological issues.
PatientReceived no prior treatments
How responsive is this trial?
Typically responds via
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