Cranial Electrotherapy for Anxiety Disorders
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.12345Why 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.13456
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
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo cranial electrotherapy stimulation or sham stimulation during cognitive assessments
Follow-up
Participants are monitored for safety and effectiveness after treatment
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?
4
Treatment groups
Experimental Treatment
Placebo Group
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).
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).
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).
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).
Find a Clinic Near You
Who Is Running the Clinical Trial?
Tufts University
Lead Sponsor
Citations
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.
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, ...
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.
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 ...
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.
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 ...
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