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Device

Active Arm for Anxiety

Phase 4
Waitlist Available
Research Sponsored by ProofPilot
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 week 4 versus week 8
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial

Summary

This trial looks at using a CES device to reduce symptoms of anxiety over 8 weeks with 2 20-min sessions/day.

Eligible Conditions
  • Anxiety
  • Generalized Anxiety Disorder

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 4 versus week 8
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 4 versus week 8 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Change in Beck Anxiety Inventory (BAI) Score
Change in Patient Health Questionnaire - 8 (PHQ-8)
Change in Promise Sleep-SD
+1 more

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Active ArmExperimental Treatment1 Intervention
Participants receive active device for the full 8 week study
Group II: Sham ArmPlacebo Group1 Intervention
Participants receive sham device for the first 4 weeks, and then at the week 5 cross over, receive the active device.

Find a Location

Who is running the clinical trial?

ProofPilotLead Sponsor
11 Previous Clinical Trials
1,556 Total Patients Enrolled
Fisher WallaceUNKNOWN
2 Previous Clinical Trials
375 Total Patients Enrolled
~30 spots leftby Nov 2025
Unbiased ResultsWe believe in providing patients with all the options.
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