130 Participants Needed

CES for Generalized Anxiety Disorder

TS
ZJ
ZS
Overseen ByZachary Stewart
Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: Electromedical Products International, Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 2 JurisdictionsThis treatment is already approved in other countries

Trial Summary

Do I have to stop taking my current medications for the trial?

You don't have to stop taking your current medications, but you need to keep the dose stable for 2 weeks before the screening visit, or 4 weeks if you're on antidepressants. You can also participate if you're not taking any medications.

What data supports the effectiveness of the treatment At-Home Stimulation, Transcranial Direct Current Stimulation (tDCS), Cranial Electrotherapy Stimulation (CES), At-Home Brain Stimulation for Generalized Anxiety Disorder?

Research shows that both transcranial direct current stimulation (tDCS) and cranial electrotherapy stimulation (CES) can help reduce anxiety symptoms. Studies have found that tDCS, especially when combined with therapy, and CES are effective in treating anxiety and depression, with improvements seen in patients with generalized anxiety disorder.12345

Is cranial electrotherapy stimulation (CES) safe for humans?

Cranial electrotherapy stimulation (CES) and similar techniques like transcranial direct current stimulation (tDCS) are generally considered safe for humans, with no serious adverse events reported in over 18,000 sessions. Mild side effects like headaches, fatigue, and skin sensations are possible, but serious issues are rare.23678

How does At-Home Stimulation differ from other treatments for generalized anxiety disorder?

At-Home Stimulation, which includes techniques like transcranial direct current stimulation (tDCS) and cranial electrotherapy stimulation (CES), is unique because it is a non-invasive brain stimulation method that can be administered at home, offering convenience and potentially fewer side effects compared to traditional medication. It uses gentle electrical currents to influence brain activity, which is different from medications that alter brain chemistry.23459

What is the purpose of this trial?

The purpose of this research study is to study cranial electrotherapy stimulation (CES) to determine its effects on symptoms of anxiety in people with generalized anxiety disorder (GAD) between the ages of 18 - 21 years of age.

Research Team

SM

Samantha Meltzer-Brody, MD, MPH

Principal Investigator

University of North Carolina, Chapel Hill

Eligibility Criteria

This trial is for young adults aged 18-21 with Generalized Anxiety Disorder (GAD). Participants must be able to consent, follow the study's procedures, and use effective contraception if applicable. They should have mild-to-moderate anxiety symptoms and either maintain a stable dose of current psychiatric meds or not change their treatment during the study.

Inclusion Criteria

I am able to understand and sign the consent form.
I am willing to follow the study rules and be available for its duration without changing my treatment unless it's medically necessary.
I have been diagnosed with generalized anxiety disorder.
See 3 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Baseline

Baseline assessments including clinical assessments of anxiety symptoms and resting-state EEG collection

1 week
1 visit (in-person)

Treatment

Participants receive either active or sham CES daily for six weeks

6 weeks
At-home daily sessions

Follow-up 1

Clinical assessments of anxiety symptoms and resting-state EEG collection

1 week
1 visit (in-person)

Follow-up 2

Final clinical assessments of anxiety symptoms and other secondary outcomes

6 weeks
1 visit (in-person)

Treatment Details

Interventions

  • At-Home Stimulation
Trial Overview The trial is testing cranial electrotherapy stimulation (CES) as an at-home treatment for reducing anxiety symptoms in individuals with GAD. It aims to understand how CES affects this age group when administered outside of a clinical setting.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Cranial Electrotherapy Stimulation (CES)Experimental Treatment1 Intervention
Alpha-Stim AID ® is an FDA-cleared device for the treatment of anxiety that delivers CES through two earclip electrodes.
Group II: Sham Cranial Electrotherapy Stimulation (CES)Placebo Group1 Intervention
The device for sham stimulation is physically identical and delivers a non-therapeutic dose of stimulation to replicate salient features of device usage.

At-Home Stimulation is already approved in European Union, United States for the following indications:

🇪🇺
Approved in European Union as Flow Neuroscience tDCS Device for:
  • Depression
🇺🇸
Approved in United States as Transcranial Direct Current Stimulation (tDCS) for:
  • Experimental for depression, chronic pain, and PTSD

Find a Clinic Near You

Who Is Running the Clinical Trial?

Electromedical Products International, Inc.

Lead Sponsor

Trials
6
Recruited
550+

University of North Carolina, Chapel Hill

Collaborator

Trials
1,588
Recruited
4,364,000+

Findings from Research

In a case series involving seven patients with various psychiatric disorders, combining self-administered transcranial direct current stimulation (tDCS) with a behavioral therapy app showed clinically significant improvements in depressive symptoms for five out of seven patients and in anxiety symptoms for five out of six patients after 6 weeks of treatment.
The tDCS treatment was well-tolerated, with only mild side effects reported, suggesting that this combination therapy could be a safe and effective option for managing depression and anxiety in clinical settings.
Home-based transcranial direct current stimulation in dual active treatments for symptoms of depression and anxiety: A case series.Sobral, M., Guiomar, R., Martins, V., et al.[2022]
Transcranial direct current stimulation (tDCS) significantly alleviated symptoms of generalized anxiety disorder (GAD) and depression in a semiprofessional athlete, as evidenced by decreased scores on the Beck Anxiety Index, Beck Depression Index, and Pittsburgh Sleep Quality Index after treatment.
Brain imaging techniques, including functional near-infrared spectroscopy (fNIRS) and functional magnetic resonance imaging (fMRI), demonstrated changes in prefrontal connectivity associated with tDCS treatment, indicating its potential as a safe and effective method for assessing brain activity in psychiatric disorders.
Effects of tDCS on Depression and Comorbid Generalized Anxiety Disorder: A Brain Function Imaging Case Report.Wu, Y., Tang, L., Shi, X., et al.[2022]
Cranial Electrotherapy Stimulation (CES) using novel in-ear electrodes significantly reduced state-anxiety symptoms in a 3-week study with nonclinical volunteers, compared to a sham treatment.
EEG analysis revealed that CES increased theta power in the left frontal region and high-beta activity in specific brain areas, suggesting that CES may positively influence brain activity related to anxiety management.
Effects of cranial electrotherapy stimulation with novel in-ear electrodes on anxiety and resting-state brain activity: A randomized double-blind placebo-controlled trial.Kim, J., Kim, H., Kim, DH., et al.[2021]

References

Home-based transcranial direct current stimulation in dual active treatments for symptoms of depression and anxiety: A case series. [2022]
Effects of tDCS on Depression and Comorbid Generalized Anxiety Disorder: A Brain Function Imaging Case Report. [2022]
Effects of cranial electrotherapy stimulation with novel in-ear electrodes on anxiety and resting-state brain activity: A randomized double-blind placebo-controlled trial. [2021]
Differential effects of cranial electrotherapy stimulation on changes in anxiety and depression symptoms over time in patients with generalized anxiety disorder. [2021]
A pilot study of cranial electrotherapy stimulation for generalized anxiety disorder. [2022]
A double-blind, randomized, sham-controlled study of cranial electrotherapy stimulation as an add-on treatment for tic disorders in children and adolescents. [2021]
A Systematic Review on the Acceptability and Tolerability of Transcranial Direct Current Stimulation Treatment in Neuropsychiatry Trials. [2018]
Low intensity transcranial electric stimulation: Safety, ethical, legal regulatory and application guidelines. [2023]
Augmenting the unified protocol for transdiagnostic treatment of emotional disorders with transcranial direct current stimulation in individuals with generalized anxiety disorder and comorbid depression: A randomized controlled trial. [2021]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security