Empower Neuromodulation System - Pilot Study for Anxiety Treatment

Generalized Anxiety Disorder Clinical Trial

Official title:

Pilot Evaluation of the Empower Neuromodulation System for Anxiety Treatment

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04901481
• Other study ID #: CRD-12-1396-01
• Secondary ID: R43AT011497
• Status: Terminated
• Phase: N/A
• Start date: September 17, 2021
• Est. completion date: May 17, 2023

Study information

• Verified date: April 2024
• Source: Theranova, L.L.C.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study evaluates the effects of peripheral nerve stimulation on anxiety levels in participants with Generalized Anxiety Disorder (GAD). This is a pilot investigation in which participants will randomized (1:1) to the active or sham treatment.

Description:

Generalized anxiety disorder (GAD) is a chronic, recurring condition that affects approximately 6.4 million American adults each year. GAD is one of the most common anxiety disorders and is costly to treat. First-line treatments for GAD include medication (e.g. SSRIs, SNRIs), cognitive behavioral therapy, or both in combination. Peripheral nerve stimulation via acupuncture has been shown to directly decrease clinical anxiety scores. The investigators have developed the Empower Neuromodulation System, a non-invasive, portable transcutaneous electrical nerve stimulation (TENS) device intended to stimulate peripheral nerves for the treatment of anxiety. In this study, a randomized, controlled study will be conducted in participants with GAD. Participants will self-administer twice daily treatments with the Empower device. In this pilot study, the primary endpoints will be feasibility and acceptability, with safety and effectiveness evaluated as exploratory endpoints.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 18
• Est. completion date: May 17, 2023
• Est. primary completion date: July 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• =19 years old

• Current diagnosis of GAD per DSM-5 via M.I.N.I. assessment by clinician

• Hamilton Anxiety Rating Scale (HAM-A) =18

• Negative urine pregnancy test at screening (females only)

• Able to provide informed consent

• Capable and willing to follow all study-related procedures

Exclusion Criteria:

• Has current (past 30 days) psychotic or bipolar disorder, homicidal ideation, psychiatric hospitalization, or moderate/severe substance use disorders per clinician assessment via M.I.N.I.

• Hamilton Depression Rating Scale (HAM-D) =18

• PTSD Checklist for DSM-5 (PCL-5) =51

• Exhibits suicidal intent as confirmed on the Columbia-Suicide Severity Rating Scale-Revised (C-SSRS-R) with a "Yes" response to question 4 or question 5 or to question 6 in the past 3 months.

• Changes in psychoactive medications in the past 30 days (including but not limited to psychotropic medications, thyroid hormone medication, steroids), with the exception of benzodiazepines

• If regularly taking benzodiazepines, has had changes in benzodiazepine dosing in the past 30 days or average use >2 days per week

• Psychotherapy was initiated or discontinued in the past 30 days or psychotherapy modality was changes in the past 30 days

• Has a history of epilepsy or a seizure disorder

• Has been diagnosed with peripheral nerve damage of the arm or hand or has numbness or tingling in the arm or hand at least weekly

• Is currently pregnant or breastfeeding, has been pregnant within the past 6 months or intends to become pregnant during the study period

• Currently has an active implant and/or an electrical or neurostimulator device, including but not limited to cardiac pacemaker or defibrillator, vagal neurostimulator, deep brain stimulator, spinal stimulator, sacral stimulator, bone growth stimulator, or cochlear implant

• Has an electrically conductive metal object (e.g. jewelry) that cannot be removed from the upper extremities and will directly contact the gel electrodes of the Empower Neuromodulation System at the active or sham anatomic location

• Has an open incision, wound, scar, active infection or otherwise compromised skin that will directly contact the gel electrodes of the Empower Neuromodulation System at either the active or sham anatomic location

• Does not have daily access to an electrical outlet for charging the investigational device and associated smartphone

• Has used of an investigational drug/device therapy within the past four weeks

• Unable to provide informed written consent

• Has any medical condition that would, in the opinion of the investigator, make the participant ineligible

Related Conditions & MeSH terms

• Anxiety Disorders
• Generalized Anxiety Disorder

Intervention

Device:
• Empower Neuromodulation System
Peripheral nerve stimulation with the Empower device. The active and sham treatments only differ by the location of application on the body.

Locations

Country	Name	City	State
United States	University of Nebraska Medical Center	Omaha	Nebraska

Sponsors (3)

Lead Sponsor	Collaborator
Theranova, L.L.C.	National Center for Complementary and Integrative Health (NCCIH), University of Nebraska

Country where clinical trial is conducted

United States, 

References & Publications (1)

Bang, Heejung et al. "Blinding assessment in clinical trials: A review of statistical methods and a proposal of blinding assessment protocol." Clinical Research and Regulatory Affairs 27 (2010): 42 - 51.

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Participant Blinding to Treatment Group at 6 Weeks	Participant blinding to treatment group will be assessed. All participants will be asked if they believe that they have received the real treatment, with possible responses of Yes, No, or Don't Know. Then, for the active and sham treatment groups, the blinding index will be calculated, where the blinding index can range from -1 to 1. A score of 1 means that all participants have guessed correctly about group assignment, a score of -1 means that all participants have guessed incorrectly about group assignment.	6 weeks
Primary	Treatment Adherence	Feasibility as assessed via treatment adherence (treatment sessions administered as a percentage of total possible) for each participant	6 weeks
Primary	Usability	Acceptability as assessed via a usability assessment (System Usability Scale (SUS)). For the SUS, the score range is 0 to 100, with a higher score indicating the stimulation system's better usability. The survey includes 10 questions in which statements about the system are rated from "Strongly disagree" up to "Strongly agree".	6 weeks
Secondary	Effective Nerve Stimulation	The percentage of treatment sessions that provide effective nerve stimulation as assessed via participant-reported confirmation of tingling sensation	6 weeks
Secondary	Satisfaction With Treatment	The overall satisfaction with treatment (via 100-mm Visual-Analog Scale (VAS)). For the VAS, the score range is 0 to 100, with a higher scoring meaning higher satisfaction.	6 weeks
Secondary	Number of Participants With Device-related Adverse Events	Safety assessment via device-related adverse events	6 weeks
Secondary	Change in Hamilton Anxiety Rating Scale (HAM-A) Score From Baseline to 6weeks	Anxiety severity evaluation via clinician-administered Hamilton Anxiety Rating Scale (HAM-A) score. For the HAM-A, the score range is 0 to 56, with a higher scoring meaning more severe anxiety.	6 weeks
Secondary	Change in Participant-reported Beck Anxiety Inventory (BAI) Score From Baseline to 6 Weeks	Anxiety severity evaluation via participant-reported Beck Anxiety Inventory (BAI) score from Baseline to 6 weeks. For the BAI, the score range is 0 to 63, with a higher scoring meaning more severe anxiety.	6 weeks