Cranial Electrotherapy for Anxiety Disorders

Overseen By Nathan Ward, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Tufts University

Disqualifiers: Neurological, Psychiatric disorders

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 30 minutes per session

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether cranial electrotherapy stimulation can reduce anxiety-related thinking problems. The device sends tiny electrical signals to the brain to test its effects on focus and memory. Some participants will receive real stimulation, while others will receive a sham (fake) treatment for comparison. Individuals who frequently feel anxious but do not have neurological or psychiatric disorders might be suitable for the trial. As an unphased trial, this study offers participants the chance to contribute to innovative research that could lead to new methods for managing anxiety.

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

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that cranial electrotherapy stimulation is safe for anxiety disorders?

Research shows that cranial electrotherapy stimulation (CES) is generally easy for patients to handle. Studies have found that CES can help reduce anxiety, with many people noticing moderate improvements. These positive effects on anxiety were noticeable over six weeks and lasted for at least a month afterward.

In terms of safety, CES is considered low-risk. Most people do not experience serious side effects. Some might feel a tingling sensation or slight discomfort during the treatment, but these feelings are usually mild and temporary. For those considering joining a trial involving CES, research suggests it is a safe option for reducing anxiety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about cranial electrotherapy stimulation (CES) for anxiety disorders because it offers a novel approach compared to traditional treatments like medication and talk therapy. CES works by delivering a small electrical current to the brain, which is thought to modulate brain activity and reduce anxiety symptoms. Unlike medications that can take weeks to show effects and often come with side effects, CES is non-invasive and has the potential to provide faster relief with minimal side effects. This innovative method could offer a new option for those who haven't found success with existing treatments.

What evidence suggests that cranial electrotherapy stimulation is effective for anxiety?

Research shows that cranial electrotherapy stimulation (CES), which participants in this trial may receive, can help reduce anxiety symptoms. Studies indicate that CES has a noticeable positive effect, significantly assisting people with anxiety. One study found CES more effective than other treatments for anxiety, with strong evidence supporting this. Additionally, a six-week CES program provided lasting benefits, reducing anxiety symptoms for at least a month. Overall, several trials have shown CES to lower anxiety levels, suggesting it might be a promising treatment option. Participants in this trial may also receive sham cranial electrotherapy stimulation, which involves no current, to compare the effects. ^{1 3 4 5 6}

Are You a Good Fit for This Trial?

This trial is for young adults aged 18-28 who experience anxiety that affects their thinking and memory. It's not suitable for those with a history of neurological or psychiatric disorders.

Exclusion Criteria

I have been diagnosed with a neurological or psychiatric disorder.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo cranial electrotherapy stimulation or sham stimulation during cognitive assessments

30 minutes per session

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

68 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cranial Electrotherapy Stimulation
• Sham Cranial Electrotherapy Stimulation

Trial Overview The study tests cranial electrotherapy stimulation, which uses electrical currents to potentially ease anxiety-related cognitive issues, against a sham (fake) treatment for comparison.

How Is the Trial Designed?

Group I: Experimental - No Induced Anxiety Experimental Treatment 1 Intervention

Participants will be administered a shock procedure in which they are exposed to safe electrical shock that will be gradually increase from (1) 30 milliseconds to (4) 80 milliseconds to an individual threshold that is uncomfortable but not painful. After this procedure, the shock belt will be turned off. Participants will be told they will not receive additional shocks during cognitive assessments. Participants will be administered cranial electrotherapy stimulation with a frequency of .5 Hz and a current of 100 microamps during 30 minutes of cognitive assessments of task switching, inhibition (stroop), working memory (n-back), and processing speed (simple reaction time).

Group II: Experimental - Induced Anxiety Experimental Treatment 1 Intervention

Participants will be administered a shock procedure in which they are exposed to safe electrical shock that will be gradually increase from (1) 30 milliseconds to (4) 80 milliseconds to an individual threshold that is uncomfortable but not painful. Participants will be told they may receive additional shocks for poor performance during cognitive assessments. Participants will be administered cranial electrotherapy stimulation with a frequency of .5 Hz and a current of 100 microamps during 30 minutes of cognitive assessments of task switching, inhibition (stroop), working memory (n-back), and processing speed (simple reaction time).

Group III: Sham - No Induced Anxiety Placebo Group 1 Intervention

Participants will be administered a shock procedure in which they are exposed to safe electrical shock that will be gradually increase from (1) 30 milliseconds to (4) 80 milliseconds to an individual threshold that is uncomfortable but not painful. After this procedure, the shock belt will be turned off. Participants will be told they will not receive additional shocks during cognitive assessments. Participants will be administered sham cranial electrotherapy stimulation with no current during 30 minutes of cognitive assessments of task switching, inhibition (stroop), working memory (n-back), and processing speed (simple reaction time).

Group IV: Sham - Induced Anxiety Placebo Group 1 Intervention

Participants will be administered a shock procedure in which they are exposed to safe electrical shock that will be gradually increase from (1) 30 milliseconds to (4) 80 milliseconds to an individual threshold that is uncomfortable but not painful. Participants will be told they may receive additional shocks for poor performance during cognitive assessments. Participants will be administered sham cranial electrotherapy stimulation with no current during 30 minutes of cognitive assessments of task switching, inhibition (stroop), working memory (n-back), and processing speed (simple reaction time).

Who Is Running the Clinical Trial?

Tufts University

Lead Sponsor

Trials

271

Recruited

595,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9218324/

Efficacy and Tolerability of Cranial Electrotherapy Stimulation ... We found CES is effective in reducing anxiety symptoms with moderate effect size in patients with both primary and secondary anxiety.

2. frontiersin.org frontiersin.org/journals/psychiatry/articles/10.3389/fpsyt.2023.1157473/full

Efficacy of electrical cranial stimulation for treatment ... The therapeutic effectiveness of CES was significantly better than that in the control groups for anxiety (ES=-0.96, p <0.00001, eight trials, ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0929664623004825

Effect of cranial electrotherapy stimulation as an add-on ... Our results revealed that a 6-week CES program was effective in alleviating anxiety symptoms, and the therapeutic effect was maintained for at least one month.

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/18348596/

A pilot study of cranial electrotherapy stimulation for ... Results: Cranial electrotherapy stimulation was associated with a significant decrease in HAM-A scores (t = 3.083, p = .01). At endpoint, 6 patients (50% of the ...

5. hsrd.research.va.gov hsrd.research.va.gov/publications/esp/CES.pdf

The Effectiveness and Risks of Cranial Electrical Stimulation ... To review evidence about the effectiveness and harms of CES for patients with chronic painful conditions, depression, anxiety, PTSD, and insomnia. Data Searches.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT01533415

Use of Alpha-Stim Cranial-electrotherapy Stimulation (CES ... The goal of this study is to evaluate the efficacy of Alpha-Stim technology in the treatment of anxiety by using a double-blind clinical trial over a period ...