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| ID | Type | Description | Link |
|---|---|---|---|
| R43AT011497 | U.S. NIH Grant/Contract | View source |
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Unable to fully enroll study.
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| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
| University of Nebraska | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active treatment | Experimental | 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. |
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| Sham treatment | Sham Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Empower Neuromodulation System | Device | Peripheral nerve stimulation with the Empower device. The active and sham treatments only differ by the location of application on the body. |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Adherence | Feasibility as assessed via treatment adherence (treatment sessions administered as a percentage of total possible) for each participant | 6 weeks |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Effective Nerve Stimulation | The percentage of treatment sessions that provide effective nerve stimulation as assessed via participant-reported confirmation of tingling sensation | 6 weeks |
| Satisfaction With Treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Burnett, MD | TheraNova, LLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Nebraska Medical Center | Omaha | Nebraska | 68198-5575 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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. |
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Of 18 subjects that signed the Informed Consent, 6 did not meet all of the Inclusion/Exclusion criteria before randomization to a study arm. Therefore, only 12 subjects were fully enrolled and randomized into the trial.
18 participants signed the Informed Consent Form and screened. 12 Subjects were fully enrolled.
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| ID | Title | Description |
|---|---|---|
| FG000 | Active Treatment | 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. 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. |
| FG001 | Sham 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. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Active Treatment | 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. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Treatment Adherence | Feasibility as assessed via treatment adherence (treatment sessions administered as a percentage of total possible) for each participant | Posted | Mean | Standard Deviation | Percentage of Treatment Sessions | 6 weeks |
|
Adverse events were recorded during the nominal 6 weeks after enrollment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Active Treatment | 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. 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Infections and infestations | Non-systematic Assessment | Norovirus |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Depression | Psychiatric disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical | TheraNova, LLC | 4159268616 | clinicalstudy@theranova.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 26, 2021 | Apr 30, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 15, 2021 | Apr 30, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000098647 | Generalized Anxiety Disorder |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
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At enrollment, participants will be randomized (1:1) to receive either the active or sham treatment for the duration of the 6-week study.
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Research staff will not provide any details that would cause participants to become unblinded to the treatment groups.
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 |
| Number of Participants With Device-related Adverse Events | Safety assessment via device-related adverse events | 6 weeks |
| 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 |
| 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 |
| 6 weeks |
| BG001 | Sham 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. 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | Years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
|
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. 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. |
|
|
| 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". | Posted | Mean | Standard Deviation | Units on a scale | 6 weeks |
|
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| Secondary | Effective Nerve Stimulation | The percentage of treatment sessions that provide effective nerve stimulation as assessed via participant-reported confirmation of tingling sensation | Posted | Mean | Standard Deviation | % of treatments that felt skin tingling | 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. | Posted | Mean | Standard Deviation | VAS score | 6 weeks |
|
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| Secondary | Number of Participants With Device-related Adverse Events | Safety assessment via device-related adverse events | Posted | Count of Participants | Participants | 6 weeks |
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|
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| 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. | Change in HAM-A score from Baseline to 6 weeks | Posted | Mean | Standard Deviation | Score | 6 weeks |
|
|
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| 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. | Change in BAI score from Baseline to 6 week visit | Posted | Mean | Standard Deviation | Score | 6 weeks |
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| Other Pre-specified | 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. | Blinding Index at 6 week visit | Posted | Mean | 95% Confidence Interval | Index | 6 weeks |
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| 0 |
| 6 |
| 0 |
| 6 |
| 1 |
| 6 |
| EG001 | Sham 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. 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. | 0 | 6 | 1 | 6 | 2 | 6 |
| Anxiety | Psychiatric disorders | Non-systematic Assessment |
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| Nausia | Infections and infestations | Non-systematic Assessment |
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| Fever | Infections and infestations | Non-systematic Assessment |
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| Burning sensation at site of electrodes | Product Issues | Non-systematic Assessment |
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