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Empower Neuromodulation System - Pilot Study for Anxiety Treatment

Primary Purpose

Generalized Anxiety Disorder

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Empower Neuromodulation System

About this trial

This is an interventional treatment trial for Generalized Anxiety Disorder

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of Nebraska Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Active treatment

Sham treatment

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Treatment adherence

Feasibility as assessed via treatment adherence (treatment sessions administered as a percentage of total possible) for each participant

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 scoring meaning better usability.

Secondary Outcome Measures

Effective nerve stimulation

The percentage of treatment sessions that provide effective nerve stimulation as assessed via participant-reported confirmation of tingling sensation

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.

Device-related adverse events

Safety assessment via device-related adverse events

Clinician-assessed anxiety severity

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.

Participant-reported anxiety severity

Anxiety severity evaluation via participant-reported Beck Anxiety Inventory (BAI) score. For the BAI, the score range is 0 to 63, with a higher scoring meaning more severe anxiety.

Responder rate

Percentage of participant who experience ≥50% reduction in HAM-A score from enrollment to study completion

Full Information

NCT ID

NCT04901481

First Posted

May 19, 2021

Last Updated

January 3, 2023

Sponsor

Theranova, L.L.C.

Collaborators

National Center for Complementary and Integrative Health (NCCIH), University of Nebraska

1. Study Identification

Unique Protocol Identification Number

NCT04901481

Brief Title

Empower Neuromodulation System - Pilot Study for Anxiety Treatment

Official Title

Pilot Evaluation of the Empower Neuromodulation System for Anxiety Treatment

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Terminated

Why Stopped

Unable to fully enroll study.

Study Start Date

September 17, 2021 (Actual)

Primary Completion Date

November 1, 2022 (Actual)

Study Completion Date

November 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Theranova, L.L.C.

Collaborators

National Center for Complementary and Integrative Health (NCCIH), University of Nebraska

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Generalized Anxiety Disorder

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

At enrollment, participants will be randomized (1:1) to receive either the active or sham treatment for the duration of the 6-week study.

Masking

ParticipantInvestigatorOutcomes Assessor

Masking Description

Research staff will not provide any details that would cause participants to become unblinded to the treatment groups.

Allocation

Randomized

Enrollment

18 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Active treatment

Arm Type

Experimental

Arm Description

Arm Title

Sham treatment

Arm Type

Sham Comparator

Arm Description

Intervention Type

Device

Intervention Name(s)

Empower Neuromodulation System

Intervention Description

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

Primary Outcome Measure Information:

Title

Treatment adherence

Description

Feasibility as assessed via treatment adherence (treatment sessions administered as a percentage of total possible) for each participant

Time Frame

6 weeks

Title

Usability

Description

Acceptability as assessed via a usability assessment (System Usability Scale (SUS)). For the SUS, the score range is 0 to 100, with a higher scoring meaning better usability.

Time Frame

6 weeks

Secondary Outcome Measure Information:

Title

Effective nerve stimulation

Description

The percentage of treatment sessions that provide effective nerve stimulation as assessed via participant-reported confirmation of tingling sensation

Time Frame

6 weeks

Title

Satisfaction with treatment

Description

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.

Time Frame

6 weeks

Title

Device-related adverse events

Description

Safety assessment via device-related adverse events

Time Frame

6 weeks

Title

Clinician-assessed anxiety severity

Description

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.

Time Frame

6 weeks

Title

Participant-reported anxiety severity

Description

Anxiety severity evaluation via participant-reported Beck Anxiety Inventory (BAI) score. For the BAI, the score range is 0 to 63, with a higher scoring meaning more severe anxiety.

Time Frame

6 weeks

Title

Responder rate

Description

Percentage of participant who experience ≥50% reduction in HAM-A score from enrollment to study completion

Time Frame

6 weeks

Other Pre-specified Outcome Measures:

Title

Participant blinding to treatment group

Description

Participant blinding to treatment group will be assessed per the method proposed by Bang et al. 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.

Time Frame

6 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Daniel Burnett, MD

Organizational Affiliation

TheraNova, LLC

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Nebraska Medical Center

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68198-5575

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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Empower Neuromodulation System - Pilot Study for Anxiety Treatment

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