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Neuromodulation Device

Empower Neuromodulation System for Generalized Anxiety Disorder

N/A
Waitlist Available
Led By Lauren Principal Investigator
Research Sponsored by Theranova, L.L.C.
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 6 weeks
Awards & highlights

Study Summary

This study is evaluating whether a device which stimulates nerves in the arm may help reduce anxiety in individuals with Generalized Anxiety Disorder.

Eligible Conditions
  • Generalized Anxiety Disorder

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Treatment adherence
Usability
Secondary outcome measures
Clinician-assessed anxiety severity
Device-related adverse events
Effective nerve stimulation
+3 more
Other outcome measures
Participant blinding to treatment group

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Active treatmentExperimental Treatment1 Intervention
Participants will self-administer treatment with the Empower device at the active treatment anatomic location twice daily for six weeks. Treatment adherence will be assessed and participants will complete surveys to evaluate the feasibility and acceptability Empower active treatment.
Group II: Sham treatmentPlacebo Group1 Intervention
Participants will self-administer treatment with the Empower device at the sham treatment anatomic location twice daily for six weeks. Treatment adherence will be assessed and participants will complete surveys to evaluate the feasibility and acceptability Empower sham treatment.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Empower Neuromodulation System
2019
N/A
~30

Find a Location

Who is running the clinical trial?

University of NebraskaOTHER
539 Previous Clinical Trials
1,144,716 Total Patients Enrolled
Theranova, L.L.C.Lead Sponsor
11 Previous Clinical Trials
451 Total Patients Enrolled
National Center for Complementary and Integrative Health (NCCIH)NIH
833 Previous Clinical Trials
669,435 Total Patients Enrolled
7 Trials studying Generalized Anxiety Disorder
609 Patients Enrolled for Generalized Anxiety Disorder

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
Massachusetts
How old are they?
18 - 65
What site did they apply to?
University of Nebraska Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Empower Neuromodulation System - Pilot Study for Anxiety Treatment
2021. "Empower Neuromodulation System - Pilot Study for Anxiety Treatment". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04901481.
~5 spots leftby Apr 2025
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